Google SEM Changes Update

In June, Google announced changes to the ways search engine marketing (SEM) would work for marketers of prescription drugs. The background on the changes and the full original update is available here.

Recently, Google has provided additional detail about the new vanity URL policy, some new options, and hard dates for implementation.

First a quick backgrounder (see the earlier post for a more extensive background).

Background

Google eliminated the black box ad format that was created in 2009, and it announced that changes would be coming to its policy on the use of redirecting URLs (aka vanity URLs) by marketers of prescription products. SEM ads that make use of redirecting URLs are one specific instance of a more general category of ad I call redirecting ads.

Redirecting ads are not limited to search engines, but they're featured very prominently in search engine marketing. The basic idea behind a redirecting ad is that the ad itself does not promote a prescription product, instead it directs viewers to another location (website, toll free number, etc.) where a prescription product is being promoted. Marketers of prescription products make use of them extensively in space-limited contexts, such as SEM, because it can be difficult to fit all of the required elements from a full product promotion into such contexts.

For SEM ads, marketers often have to use these ads because their only other option is using a reminder ad, and a reminder ad is by definition worthless if the person seeing the ad doesn't already know the name of the product.

So, the key features of a redirecting SEM ad are:

1. Does not mention or imply a specific prescription product
2. Provides a link to a prescription product website
3. Displays a URL that does not match the destination page URL

It's that third element (the mismatch between the display and the destination URL) that has caused Google some agita. Google has long had a policy that prevents advertisers from having a significant mismatch between the display and destination URL. Google has previously been making an exception to that policy for marketers of prescription products precisely because there didn't seem to be any other option for them when a reminder ad would not work.

June Announcement

In June, Google announced that it would be changing its exception to that policy. At the time, Google said that instead of permitting marketers to invent their own display URL, Google would limit marketers to just three options.

1. Use CompanyName as the display URL
2. Use CompanyName.com as the display URL
3. Use "Prescription treatment website" or "Prescription device website" as the display URL

Latest Update

Now, Google has changed those options. First, Option 1 is no longer available. The only possible display URL using a company's name is for the display URL to be CompanyName.com. Moreover, to use that option, the URL itself must be live and the advertiser must own the URL. It is important to note that although the DISPLAY URL will be CompanyName.com, the DESTINATION URL  (i.e., the page people land on when they click on the ad) is completely under the control of the advertiser and does not have to be the company's main website.

In addition, the display URLs available under Option 3 have expanded significantly. Whereas the June announcement mentioned only two possibilities ("Prescription treatment website" or "Prescription device website"), there are now six display URLs available in both English and Spanish. Those display URLs are:

1. Prescription treatment website
2. Prescription device website
3. Medical device website
4. Preventative treatment website
5. Prescription contraception website
6. Prescription vaccine website

In Spanish:

1. Sitio de tratamientos con receta
2. Sitio de dispositivos con receta
3. Sitio de dispositivos médicos
4. Sitio de tratamientos preventivos
5. Sitio de anticonceptivos con receta
6. Sitio de vacunas con receta

Again, just as was previously announced, manufacturers of prescription products will be able to choose any of these display URLs, but whereas "CompanyName" in CompanyName.com is a template that will be filled in with the actual company's name, the options above must appear exactly as presented.

Timing

In addition to this change in the number of options, and the Google text options, Google has also announced the timing for these changes to take effect. There are three timing deadlines to keep in mind. The first is now.

Marketers who choose to make use of the option to use CompanyName.com as the display URL can immediately begin doing so. There is no need to wait, but there's also no requirement to do that immediately.

The next milestone is February 1, 2016. Beginning on that date, all of the 12 display URLs (six in English and six in Spanish) will be available as possibilities for redirecting ads to use.

Finally, the deadline for transitioning to these new options is March 1, 2016. On that date, no ads that are running using customized vanity URLs will be able to run. All ads must switch over to either of the two options:

1. CompanyName.com
2. One of Google's 12 display URLs
1. Prescription treatment website
2. Prescription device website
3. Medical device website
4. Preventative treatment website
5. Prescription contraception website
6. Prescription vaccine website
7. Sitio de tratamientos con receta
8. Sitio de dispositivos con receta
9. Sitio de dispositivos médicos
10. Sitio de tratamientos preventivos
11. Sitio de anticonceptivos con receta
12. Sitio de vacunas con receta

Implications

Search engines are vital to people using the Internet looking for health information. Consequently, marketers cannot afford to ignore SEM ads, and since these changes have been announced, there is plenty of time to update SEM campaigns to conform to these new Google-specific guidelines, and it is worth emphasizing that as I write this blog post, there is no word as to whether Yahoo!, Bing, or other search engines will also be adopting similar policies.

Additionally, marketers and their regulatory counterparts will have to review these ads to determine whether they need to be adjusted beyond the change in URL to avoid the implication of a specific prescription product; and we will have to wait to see how users adapt to seeing multiple ads using the same words as their display URL for unique ads.

21st Century Cures Act Tracker

I found this handy legislative tracker, so I'm adding it to the blog, so you can bookmark this post to stay updated on this legislation. Currently, it's in the Senate and has been assigned to a committee.

The Amarin Injunction

On August 7, 2015, a federal district judge issued a preliminary injunction prohibiting the FDA from taking action to prevent Amarin Pharma from disseminating off-label information about Vascepa for the treatment of patients receiving statins who also had persistently high levels of triglycerides. This action has been widely hailed as a significant blow to FDA's authority to regulate off-label promotion and also as a major victory for defenders of the first amendment rights of pharmaceutical companies, and while I've seen and read many blogs and news stories dissecting the ruling for attorneys (I recommend this and this from FDAlawBlog), I haven't seen anyone discuss how this affects FDA regulatory professionals. That's what this blog entry is intended to address.

For this post, I feel the need to reiterate that I'm not an attorney, and nothing you read on this blog should be construed as legal counsel.

Background

Amarin's Vascepa is currently approved by FDA as a drug indicated along with diet to lower triglyceride levels. Amarin sought expanded approval for patients who were taking statins and continued to have higher cholesterol levels. To gain this approval, Amarin entered into a Special Protocol Assessment (SPA) with FDA, where FDA sets out and agrees to a specific study design, endpoints, etc. Generally, if companies abide by the SPA and the study meets its primary endpoints, approval is a foregone conclusion.

In this case, Amarin followed the SPA and met the primary endpoints, but the FDA decided that research conducted in the interim had cast doubt on whether the endpoints were meaningful, so FDA convened an advisory board, which voted against approval, and then FDA issued a complete response letter to Amarin denying the approval. FDA stated in its complete response letter that Amarin should NOT promote Vascepa for the expanded indication.

Amarin filed suit against FDA stating that FDA was attempting to preemptively prevent Amarin from disseminating truthful, non-misleading information about its products.

In response to this suit, FDA sent a letter to Amarin (and the court) stating that FDA did not object to any of the information that Amarin intended to disseminate, so long as Amarin made certain disclosures about that information.

That takes us to the preliminary injunction.

Key takeaways from the Amarin ruling:
1. Dissemination of off-label reprints is uncontested.
Though previous FDA guidance on this topic would seem to have firmly enabled this practice, there nonetheless have been holdouts and suspicion about its provenance. This ruling further enhances the confidence companies can have in the permissibility of disseminating these reprints.

2. Disclosures are crucial.
One key component of the injunction that was ignored by many is that Amarin wanted to omit information about FDA having declined to grant approval for the use being studied. The judge disagreed with Amarin, and though he didn't entirely accept FDA's proposed wording of the disclosure, he did agree that Amarin needed to provide the information that not only was the use not currently approved, the FDA declined to approve that indication.

3. There's more to come.
The judge issued this ruling on August 7 granting Amarin the preliminary injunction it sought. The preliminary injunction was a sign that the judge thought Amarin was likely to succeed based on the merits of the case, but it was not itself a final decision; and it appears unlikely that such a decision will be reached because on August 28, Amarin and the FDA requested that the judge hold off on ruling on the underlying case because the two parties were working out a settlement. The nature of that settlement might provide greater clarity, if it is publicly released.

4. The status quo is unchanged.
As much as the ruling itself was heralded in many circles as a significant blow to FDA's authority to prohibit off-label promotion, at the end of the day nothing has changed. FDA had already stated that it would not have objected to Amarin's dissemination of the information if certain disclosures were provided. So, the injunction ruling prevents FDA from taking an action that FDA had already said it didn't intend to take.

This wasn't so much a landmark ruling against FDA as it was tweaking around the edges of how to follow FDA's off-label reprint guidance, but the specifics of the case are highly relevant. Unless your company happens to be in the 2nd circuit and to have entered into a Special Protocol Assessment with FDA and to have had the specific indication rejected by FDA, it will be very difficult to apply the principles of this ruling to your situation (such as how to modify your disclosures outside of FDA's guidance on the matter). And in the meantime, companies should feel quite comfortable disseminating off-label reprints in accordance with FDA's previously issued guidance while avoiding off-label promotion itself.

The Danger of Celebrity

Kim Kardashian's Instagram account joins a long line of celebrity endorsers whose communications have been cited by the FDA.

The following list is definitely incomplete, and I'd appreciate people adding to it in the comments, but this is just a smattering off the top of my head of the celebrity endorsers who have been cited in FDA enforcement:

Magic Johnson in 2009 for Kaletra

Ty Pennington in 2008 for Adderall

Eric Bergoust in 2002 for Tamiflu

Joan Lunden in 2000 for Claritin

Jackie Joyner-Kersee in 1997 for Flovent

Are celebrities dangerous?

Well, they are likely to be featured in high-profile campaigns, especially television advertising, and FDA has always made clear that from a public health perspective, they pay particular attention to high-profile campaigns because their broader reach translates into a greater public health impact.

In addition, celebrities can present a host of issues for otherwise-staid pharmaceutical company employees. There's certainly something thrilling about getting to meet them, and there might be a bit of reticence to tell them exactly what to say. Celebrities themselves are frequently going to have significant experience with endorsing products, and that experience can make them more dangerous. The rules of the road for pharmaceutical promotion are just different, and if a company doesn't have sufficient procedures in place to ensure compliance with scripts and specific language, then it's very easy to start weighing the costs of a reshoot against the risk of FDA enforcement. And once that Rubicon has been crossed, it's very difficult to return.

What Kim Kardashian Could Have Done

Update: Apparently some people are weighing in on this issue who don't follow FDA ad-promo issues. For their benefit, I'm including a link to my post about why a link to the risk information doesn't suffice, i.e., why one-click isn't a rule.

Today, FDA's Office of Prescription Drug Promotion posted a letter citing Duchesnay for violative promotion relating to social media posts made by Kim Kardashian. The violative materials clearly included a discussion of the product's indication combined with the use of the product name, and a picture of Ms. Kardashian holding the product's bottle with the name prominently displayed.

Instagram Post from Violative Materials on FDA Website

It should come as no surprise that FDA objected to this presentation. In its letter, FDA cited both an omission of material fact and the omission of risk information.

And though I risk being accused of doing this solely for the clickbait, I'd like nonetheless to spend a bit of time looking at the violations, and the promotional material because there were options to engage in this promotional activity while complying with FDA's regulations and guidances.

First, look at the image above. Clearly, the image itself included the product name, and the submission to the FDA included a note stating that "image of Diclegis bottle will be prominent enough to read established name." This image (if used alone) would probably have been OK as a straight reminder promotion, which is only required to include the brand and generic names. It is, admittedly a bit difficult to tell from the material posted by the FDA whether the note on the material is indeed accurate, i.e., whether the generic (established) name would indeed have been legible, but it certainly is within the realm of possibility that both the brand and generic name would have been legible, and thus that the image alone might have been acceptable promotional material.

And if the image had been used alone (and the generic was actually legible), then it would have been compliant, so that was Duchesnay's first option. Engage in Reminder Promotion. Just show Ms. Kardashian holding the product bottle.

Option 2 would have included additional copy but still remained within the reminder ad format. You could easily imagine copy along the lines of: "I use Diclegis. You should ask your doctor about it." Such copy would not inherently have provided any indication or representation of the product's usage, and thus would appear to be acceptable within the reminder ad format.*

However, the accompanying text did not limit itself to the reminder ad format. Instead, that copy clearly alluded to the product's indication with Ms. Kardashian's message discussing her morning sickness and making a claim about the product's efficacy and its safety.

Of course, another option for Duchesnay (and Ms. Kardashian) would have been to omit the product mention and simply redirect followers to a location where the full product promotion could have been delivered. Such a communication could have teased the product, "Guess what helped me alleviate morning sickness" so long as it didn't refer to, or imply, the specific product.

That would have been tricky to do since Diclegis is currently the only FDA-approved treatment for morning sickness, but I think it would have been possible to do so, especially in a product category where there are tons of home remedies, homeopathic, and other OTC drugs that are used (sometimes off-label) for morning sickness.

So, this is Option 3: A redirecting ad that omitted product mention (or picture) but that took people to a location where the full product promotion could have been supplied.

Would it have been possible for Duchesnay to take advantage of the space-constrained product guidance released by the FDA on National Social Media Guidance Day?

The first thing to notice here is that although I've only posted and discussed one post from Ms. Kardashian, there are at least three that were involved in the violative materials. In addition to the Instagram post shown above, there was a Tweet and a Facebook post:

Tweet from Violative Materials on FDA Website

Facebook Post from Violative Materials Posted on FDA Website

Instagram does appear to have a character limitation to its posts. The limit is 2,200 characters. Diclegis.com has an ISI posted with more than 3,000 characters, so it would have taken some editing to fit the complete ISI into the post, but it's not entirely clear that the editing would have reduced the total information provided. Hence, it's unclear whether there would have been any need to take advantage of the space-limited guidance to accommodate a compliant message in this particular forum.

Of course, the third post is a Tweet, and the Tweet makes use of precisely the redirecting ad format discussed above in Option 3. However, instead of redirecting users to a page with all of the elements required to meet the product promotion requirements, the Tweet directed users to the Instagram post, which the FDA found to be violative.

I've previously commented on how difficult it is to fit all of the required elements into a Tweet, and it's an open question whether Duchesnay could have done so.

Let's try.**
Required elements are:

1. Brand name
   Diclegis--8 characters
2. Generic name
   doxylamine succinate and pyridoxine hydrochloride--49 characters
   But taking advantage of FDA's willingness to accept abbreviations, we can shorten that to doxylamine succinate & pyridoxine HCl--37 characters
3. Non-misleading indication statement
   It's unclear exactly what FDA would have considered an acceptable statement of the indication. We know from the letter that FDA considered the omission of the limitation that the product has not been studied in those with severe vomiting (hyperemesis gravidarum) an omission of material fact, so presumably that would have been needed in the Tweet. Let's try
   For morning sickness, but not w severe vomiting--47 characters
4. Contraindications (other than mere hypersensitivity to the active ingredients)
   In the case of Diclegis, this means those using MAOIs
   Don't use w MAOIs--17 characters
5. Abbreviated risk statement*
   Risks incl severe drowsiness--28 characters
6. Link to full risk info
   Diclegis.com/risk--22 characters***

Putting it all together, you'd have

Diclegis(doxylamine succinate & pyridoxine HCl) For morning sickness, but not w severe vomiting Don't use w MAOIs-Risks incl severe drowsiness Diclegis.com/risk

That's a total of 165 characters, and I'm taking some liberties by using abbreviations FDA has not formally endorsed, and perhaps underestimating the characters FDA might require to communicate some of the elements.

Now, though, consider the context. Imagine for a moment that the character count were 139 instead of 165. Could anyone imagine Ms. Kardashian sending out that Tweet?

I can't either.

So, this takes us back to the options above:

• Option 1: Picture Reminder Ad (Product pic with generic name prominent and legible)
• Option 2: Reminder Ad with Additional Copy
• Option 3: Redirecting Ad

Absent any changes, that's where prescription product promotion in social media stands, and we'll need to do some work to keep up with...(just can't finish that sentence).

* I'm assuming that the bottle would have been a more prominent presentation of the generic name than the copy, but the specific execution of this option might have required inclusion of the generic in the copy as well.
** Note that in the following, I am taking advantage of several abbreviations that have not been explicitly endorsed by FDA (such as the use of "w" for the word "with" and "incl" for the word "include"). These abbreviations are extremely common on Twitter, but they do go beyond FDA's explicit endorsement of the "&" for the word "and."
*** For more on why this is 22 characters long, see my earlier post on counting characters.

One-click Legislation Lives On

On Friday, the House of Representatives passed the 21st Century Cures Act. An early draft of this legislation included a provision about social media that would have essentially written the one click rule into law.

This video presents the exchange between Dr. Janet Woodcock, who leads the Center for Drug Evaluation and Research at FDA, and Representative Billy Long of Missouri about that provision (exchange begins at 2:35:35 mark).

Unfortunately, that provision didn't make it into the final version that passed last week; however, one click isn't finished just yet. As I discussed in a new column for DTC Perspectives and another recent article in The Medicine Maker, this is far from finished.

Representative Billy Long of Missouri has sponsored this item as a standalone piece of legislation. In addition, copy and paste is one of the easiest technologies to master, and once draft language is available, there is a tendency for it to get picked up in other efforts that aren't always directly related.

It's worth noting in that regard that discussions have kicked off in earnest about the renewal of the Prescription Drug User Fee Act (PDUFA). The last time this legislation came up for renewal was 2012, and that renewal included a mandate that FDA release guidance about using social media, leading directly to a new national holiday.

At the moment, one click doesn't have a Democratic cosponsor, but I know from conversations with Rep. Long's office that they consider this a bipartisan issue and expect to find a Democrat to sign on. Certainly, from my perspective, there is nothing partisan about this topic. People are adopting social media channels, and there is an incentive for industry to provide truthful, balanced, FDA-regulated information to them. But FDA's current interpretation of the regulations makes it difficult (and frequently impossible) for industry to provide that information.

It is worth pausing to consider the implications of industry's forced absence from these conversations. Of all of the information that is available about prescription treatments, the ONLY information over which the FDA has jurisdiction is promotional communication by industry. So, the only people who are required by the FDA to provide accurate, balanced information are currently being hindered in their efforts to provide that FDA-regulated information.

And as Aristotle (and Gary Larson) taught us, nature abhors a vacuum. Absent industry's involvement in these platforms, others, who don't face the same restrictions, will participate. Some of that information will be accurate; some of it won't. None if it will be subjected to the same high standards required by the FDA for industry's communications.

Google Search Engine Marketing Changing

Update: Google has announced additional details and specific timing for the vanity URL changes discussed below. You can read the full update here.

Google has announced two significant changes to the way paid search engine advertising works for pharmaceutical products.  The first change affects only black box drugs and will take effect beginning July 20, 2015. The second affects redirecting ads and will take effect in January of 2016.

Following some background on the history of FDA enforcement and how companies adjusted to those actions, this post explains the changes Google is making and explores their implications.

Background*

In March 2009, the Food and Drug Administration sent 14 letters for violative search engine marketing practices of 48 brands. Thirteen of these letters explicitly referred to SEM ads running on Google, while the last one actually cited organic search listings on Yahoo!, but everyone (including the FDA) acted as if those were SEM ads also.

The FDA identified four types of violations in its 2009 enforcement actions:
1. omission of risk information
2. inadequate communication of indication
3. overstatement of efficacy
4. failure to use the required established name

Omission of risk information means the ads did not include risk information. Not all prescription drug advertising is required to include risk information; however, if a product promotion mentions (or implies) a specific product and includes information about that product’s usage or benefits, it is required to include risk information to meet the fair balance requirement (21 CFR 202.1(e)(5)(ii)). This is the only violation that was cited in every letter, and thus the apparent trigger of this unprecedented simultaneous issuance of 14 letters.

Sample 2009 Violative SEM Ad

Inadequate communication of indication is familiar to readers of FDA enforcement letters and most often relates to the failure to make clear restrictions on the drug’s intended use. (21 CFR 202.1(e)(3)(ii)). For example, the paid search listing for Flomax included the phrase “Learn About Treating Prostate Problems.” According to FDA, that implied a broader intended use than contained in Flomax’s Prescribing Information, which states Flomax is indicated specifically for treatment of the signs and symptoms of benign prostatic hyperplasia. More than half of the drugs cited were found to have impermissibly broadened the indication.

Only one drug (Mirena) was alleged to have overstated efficacy by “failing to reveal that Mirena is only indicated for up to 5 years of use before replacement.”

Failure to use the established name refers to the inclusion of the generic (i.e., “established”) name of the drug. Forty-two of the 48 cited drugs failed to include the established name. For more on this topic, see here.

None of the ads cited by the FDA were compliant reminder ads, which are required to include only two elements:
1. Brand name (if applicable)
2. Generic name and/or active ingredient

In addition, reminder ads are permitted (though not required) by regulation to include:
1. quantitative ingredient statements (e.g., 20 mg)
2. dosage form (e.g., tablets or capsules)
3. quantity of package contents (e.g., 30 pills per bottle)
4. price
5. name and address of the manufacturer, packer or distributor
6. other information so long as it makes “no representation or suggestion” about the product use

Importantly, certain drugs with severe warnings, so-called black box drugs, are forbidden to engage in reminder ads. (21 CFR 202.1(e)(2)(i))

However, as noted previously on this blog, FDA has acknowledged the existence of a separate category of communications, which they call Reminder-like ads. Reminder-like ads share many of the same features of reminder ads, in that they are not permitted to make any representation about the use of the drug, but reminder-like ads have additional requirements.

A compliant reminder-like ad for a black box drug must include:
1. Brand name (if any)
2. Generic name of the product and/or active ingredients
3. "Please see..." statement directing people to the PI or Brief Summary
4. Provision of a PI or Brief Summary immediately accompanying the advertisement

Following the FDA's enforcement activity in 2009, SEM ads for prescription drugs basically stopped. Then, industry regrouped and began running compliant reminder ads and/or redirecting ads.

Redirecting ads (a phrase I coined) have the following characteristics:
1. Nothing in the SEM ad mentions or implies a specific product.
2. The display URL redirects to a distinct destination URL.
3. The destination URL is a product-specific promotional website.

Sample Redirecting Ad from 2009 Enforcement Action--Not Cited as Violative

In addition, Google created a new dedicated ad format that was only available to marketers of prescription drugs with a black box. That ad format has an additional line of copy and a separate destination link.

Yaz was the first brand to use Google's black box ad format.

The dedicated line of copy reads, "“Click to see full safety and prescribing information, including boxed warning. More info." The words "More info." contain a separate hyperlink that takes people who click on it to a page dedicated to the presentation of risk information including the boxed warning.

Though the FDA has never directly addressed the Google black box ad format in any guidance or public statement, this ad format seems to fall within the scope of the reminder-like ads that the FDA has acknowledged are compliant.

Google's Changes

There are two separate changes to Google's policies regarding pharmaceutical company SEM ads.

First, Google is discontinuing the dedicated black box ad format. This will no longer be available for anyone.

This change will take place on July 20, 2015. Beginning that date, any ads using the black box format will no longer run.

Instead, all marketers of black box drugs will have to make use of the standard ad format without the additional dedicated line of copy and the separate hyperlink to a page dedicated to risk information.

While this is likely to upset many pharmaceutical companies, for most companies, it will be possible to develop a compliant reminder-like ad within the standard ad format for their black box drugs.

Sample reminder-like ad in standard ad format

Specifically, such ads will have to take advantage of the reminder-like ad format that FDA has acknowledged as being compliant. These ads will need to include the brand and generic name as well as a "Please see" statement directing users to the full PI including boxed warning.

The only open question in terms of FDA compliance is whether it suffices to have the accompanying PI be provided via a second hyperlink from the destination page as opposed to having a separate dedicated hyperlink in the original ad. The FDA's previous statements about the provision of a PI for reminder-like ads have been silent on this question (as noted here).

It is worth noting that in FDA's recent guidance about providing risk and benefit information in space-limited context, FDA considered it acceptable to provide the PI via a hyperlink from the destination page as opposed to having a separate dedicated link to the PI. (page 10)

Of course, that guidance did not directly address reminder-like promotion, and in fact, explicitly exempted all reminder ads from its scope. (see page 4 note 10)

Nonetheless, it is not too far fetched to believe that if the PI can be provided via a hyperlink from the destination page when the ad itself contains product benefit and risk information, then it would also be acceptable to have the PI provided in the same fashion for a reminder-like ad that does not contain any representation about a product's usage.

In addition, many companies currently making use of Google's dedicated black box ad format currently just provide a link to a webpage with risk information (not a direct link to the PI), and none of those ads have been cited by the FDA as being violative.

One benefit for pharmaceutical companies of this change is that the black box ad format never worked on mobile phones. That ad format was dedicated exclusively to desktop/laptop computers and larger tablets. Consequently, some black box drugs were already adopting the standard ad unit for their mobile campaigns making use of the reminder-like ad format without having the black box ad format available.

By being forced to adopt the standard ad format, marketers will be forced to adopt a format that is available on mobile devices.

Sample mobile ad for black box drug

The second change deals with the so-called redirecting ads. As noted above, these ads have been running without receiving any enforcement action from the FDA both before and after the infamous 14 letters of 2009.

FDA has never objected to marketers making use of this format, nor, so far as I'm aware, has FDA acknowledged that these ads exist. In previous discussions of these ads, I have speculated that the reason for this silence is that FDA does not clearly have any authority over these ads when done correctly because they do not explicitly reference or imply a specific prescription product.

I have also noted that this ad type is not in any way limited to SEM ads. Redirecting ads can be used on television commercials (for example, see this), billboards, print ads, or any other medium. The basic idea just is that redirecting ads do not themselves promote a prescription product. Instead, they direct people to another location (URL, telephone number, etc.) where they can see the ad for a prescription drug.

Google has long had a policy prohibiting ads where the destination URL differs dramatically from the display URL. Such advertising is not limited to the pharmaceutical industry, and while it is sometimes done by reputable, legitimate advertisers, it is also a practice that is shared by many unsavory practitioners. That is why Google has strictly forbidden it across the board, except for the pharmaceutical industry.

This exception was maintained because in many cases, the reminder (or reminder-like) ads discussed above don't seem appropriate. For example, if a user doesn't already know the name of my prescription drug, then a straightforward reminder ad might be at best worthless for the user who by definition isn't being reminded of anything since she isn't already aware of the product. And depending on the specifics of the case (for example, whether the user is aware that there are prescription treatment options for her condition, or whether prescription drugs frequently advertise without describing their uses), such a reminder ad might actually seem less appealing than other ads (for example, over the counter or homeopathic treatments that describe the product's name and use).

To reach such people, prescription product marketers have been using the redirecting ads, but beginning in January of 2016, Google will no longer permit advertisers to have vanity URLs (such as "PrescriptionTreatmentforConditionX.com") that redirect users to a website (e.g., BrandY.com) that promotes a specific treatment.

Instead, prescription product marketers will have three options for the display URL.

Option 1

They can simply display the company name as the display URL.

Sample ad showing company name as URL

Option 2

They can add ".com" to the company name.

Sample ad showing company name plus .com as URL

Option 3a (for prescription drugs, biologics, and presumably vaccines)

They can display the phrase "Prescription treatment website" as the display URL.

Sample ad showing prescription treatment display URL

Option 3b (for medical devices)

They can display the phrase "Prescription device website" as the display URL.

Sample ad showing device display URL

The only difference for marketers of prescription products between the new and the old redirecting ad formats is that there will no longer be any latitude in what display URL can be shown.

As noted earlier, the FDA has never commented officially in public on any of these ads, nor have any such ads been subject to enforcement action, so this change doesn't seem to face any immediate difficulties from the FDA.

There are, however, implications depending on which ad format is chosen. For example, one feature of the redirecting ad format is that the ad not only doesn't mention a product name, it also doesn't imply a specific product. FDA has taken enforcement action against products that made use of redirecting URLs when they deemed the ad itself to have implied (though not mentioned) a specific product.

So, in deciding which of the three options is the right one for a product, reviewers will have to consider whether inclusion of the company name or the phrase "Prescription treatment" (or "device") combined with the rest of copy implies a specific product.

It is also worth pointing out that this change by Google doesn't appear to have any obvious implications for the use of redirecting ads in other media (such as billboards and television). Google isn't preventing advertising from using URL redirects tout court. They can't do that. The only thing they can do is prevent advertisers from using certain redirecting URLs in Google paid SEM ads.

Conclusion

As a first step, marketers of prescription products will have to review all existing Google SEM ad campaigns. In some cases, these changes could completely stop all SEM advertising for a product (e.g., if a black box drug is only running the dedicated black box ad format) as soon as July 20. Most marketers, however, will face far less interruption. And for some marketers (those marketing products without a black box and not using the redirecting ad format), there will not be any changes at all.

Finally, it's worth noting that although Google dominates the search engine market, it is not the only player in town. Yahoo!, Bing, and others have their own policies, and it is dangerous to assume that everything Google does will be carried over to those other platforms. Individual campaigns will have to be modified to work across all platforms.

Given the immense importance of search engines, SEM is far too vital to fail to address these changes, and because people rely on search engines to find the information they need about their health, marketers have to make their information available via this channel.

* The following discussion draws heavily on my article about developing compliant search engine marketing from the September 2014 issue of Regulatory Focus. That article is now outdated, but I'll continue to keep it posted publicly here.

"New" Mobile Apps Guidance Released

I'm using the word "new" in the headline of this blog post in the technical sense that FDA uses for promoting drugs, namely within the past six months, because the new guidance was actually published in February of this year. I didn't notice it at the time, so apologies for the late notice.

I'm blogging about it anyway because the topic is of interest in general (namely what apps are subject to FDA enforcement focus vs. enforcement discretion), and because the update itself is interesting to FDA process geeks like me.

Here's a quick timeline for the uninitiated:

In 2011, FDA released its first draft guidance* about how it would apply its regulatory authority to the realm of mobile apps. Here's my take at the time.

Industry (and Congress) reacted as if FDA were suddenly imposing a new set of regulations on a vibrant and rapidly evolving technology, despite the fact that FDA had been regulating apps for years.** As a result, there was significant pressure exerted on FDA to finalize its guidance.

In 2013, FDA released a finalized version of the guidance. Here's my take at the time.

In 2014, FDA released a new draft guidance about Medical Device Data Systems. As I noted at the time, this guidance significantly downgraded the regulatory status of MDDS, essentially shifting the entire category of apps from the group of apps where FDA would focus its regulatory attention to the group of apps where FDA would exercise "regulatory discretion," i.e., choose not to enforce regulatory requirements.

In addition, this guidance also by extension altered the finalized mobile apps guidance, and though I agreed (and continue to agree) with this decision, I mentioned that this created an odd situation for those relying on FDA's guidance. We had a new draft guidance about MDDS, which was making revisions to the mobile apps guidance, without any indication in the mobile apps guidance itself that it was undergoing a revision.

Instead, FDA is maintaining a separate, real-time listing of apps that it is updating as individual classification decisions are being made.

I applaud this innovation. I think it helps industry tremendously to have FDA maintaining this consolidated listing of decisions, especially because (as the MDDS guidance itself shows), FDA is willing to reconsider these decisions as the technology evolves.

The wrinkle is that you have to keep on top of these process issues closely to understand them. Otherwise, you'd find yourself going to the guidance, which was always kept in its final status, and assume that you were reading FDA's current thinking about a topic without realizing that FDA had released other, newer guidance that contradicted the position from the "final" guidance.

Well, as of February of this year, that discrepancy has been resolved. FDA finalized the MDDS guidance, and at the same time (apparently), released an updated final mobile apps guidance.

In reading through the new version of the final guidance, it does not appear any significant changes have been made to the FDA's classification scheme for mobile apps, or any additional reclassifications have been introduced; however, if anyone finds such changes, please point them out in the comments.

* I'm posting this (and other) guidance on my own site. My sharing these documents should not be construed as endorsing the views set forth in it, nor should it be taken as a sign that these views represent FDA's current position. This link is merely being provided for historical research purposes and use by others who would like to see how FDA's position has evolved.
**According to both FDA and press, FDA has been clearing (i.e., regulating and accepting apps as medical devices) since at least 1997.

Help-Seeking Guidance Withdrawal Update

Last week, FDA withdrew 47 guidance documents, including the disease awareness guidance that has become so central to ad-promo professionals. As I mentioned at the time, this move left those of us who care about these issues in a bit of a quandary.

It certainly seemed from FDA enforcement activities and other statements that many (if not all) of the principles set forth in that guidance still represented FDA's view, but the guidance itself was technically no longer an official statement of FDA's position.

Since I was teaching a two-day ad-promo class for FDAnews this week, I reached out to OPDP about whether I needed to radically alter my treatment of the topic of disease awareness in light of this development.

I received the following statement in response:

FDA continues to believe that disease awareness communications can provide important health information to consumers and health care practitioners, and can encourage consumers to seek, and health care practitioners to provide, appropriate treatment.  While many of the principles in the withdrawn draft guidance are still relevant, we are taking this opportunity to work on an updated draft guidance that considers new technologies and includes information about social science research to better reflect FDA’s current thinking on help-seeking and other disease awareness communications.

I'm sharing this with the community because I think it provides important amplification on the initial withdrawal statement.

FDA is apparently working on a new updated draft guidance (despite that guidance not being listed on the 2015 guidance agenda). Also, FDA continues to endorse the view that disease awareness communications are important and can improve the public health.

I'm particularly excited to see what FDA has to say about new technologies. The 2004 guidance was silent on the use of the Internet, and as readers of this blog might know, I've been curious about this topic for several years.

So stay tuned. Clearly there's more coming.

 

How Not to Submit Interactive Materials to FDA

In two recent guidances, FDA has requested that sponsors submit materials "in an archivable format that allows FDA to view and interact with the submission in the same way as the end user (e.g., working links)."*

I understand the need to experience digital promotional communications in their native environment to fully appreciate the communication and ensure its compliance.** However, achieving the stated goal of creating an experience for the FDA reviewer in the submission that is the same as the end user is not practical.

The most common format for submitting materials to FDA for the postmarketing submission of promotional materials is via the .PDF document format. Websites, emails, and other digital tactics are converted into PDFs. Typically, this process is achieved by taking screen shots of each webpage or other unit, gathering those screens into a convertible format such as .jpeg files and combining those files into a single .PDF file.

There are various techniques for doing this, and lots of software out there to assist with both the screenshots and the conversions. Adobe has at various points provided software additions that purported to convert an entire website into a single .PDF file at the click of a button. I've worked with most if not all of these solutions, and none of them work. At the end of the day, the only reliable technique to create a .PDF file that looks like the finished piece is to do so manually.

To convert such a file into a piece that functions in the same way as the original thus requires manually building into the .PDF file individual links that move the user around the PDF in the same way as the hyperlinks behave in the website (or email, etc.).

Depending on the complexity of the original piece, that task can be considerable. For example, a 12-page website probably actually has about 25 pages once error states, index pages, and other miscellaneous aspects are included. Assuming 10 hyperlinks per page (which is low), that's more than 120 individual hyperlinks that have to be created (and checked) prior to submission. It's very easy to introduce an error during that manual build.

And the resulting PDF will never be used other than for a 2253 filing. So, there's a lot of effort to create something that no one (outside FDA and the sponsor company) will ever see. A lot of effort with a high likelihood of error for no benefit.

As if this were not reason enough to avoid creating this file, the timing for its creation could not be worse. Digital tactics aren't like print ads. When I submit a print ad to the FDA for a postmarketing submission, the actual ad itself is unlikely to be on newsstands for several days or even weeks. But a digital tactic will often go live immediately after the materials are submitted to the FDA. Every additional minute spent creating the file for the postmarketing submission is a delay in making the materials available.

This also ramps up the pressure on the ad agency or other responsible party to complete the submission as rapidly as possible. That pressure further increases the likelihood of an error being introduced.

To recap, creating fully functional PDFs that recreate the end user experience of a digital tactic is an expensive, time-consuming, error-laden process that delays the deployment of promotional communications and benefits no one other than the FDA reviewers. This is one time I think industry is likely to ignore FDA's request.

* Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics, page 6, note 7. See also "The website should allow the FDA reviewer to click on links within the website," in Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs, page 31.

** Indeed, a significant portion of my primer on this topic is devoted to the idea that reviewers have to understand and experience the platform to determine its compliance.

Help-Seeking Communications Guidance Withdrawn

FDA announced today (technically tomorrow) that they are withdrawing nearly 50 guidances.

One of these guidances has become a staple for ad-promo professionals who have turned to it repeatedly in the more than 10 years since its initial publication.

The notice in the Federal Register provides the following rationale for the withdrawal of these guidances:

Many of these draft guidances were not finalized most often because of higher priorities and resource issues. However, over the years, because of new information, scientific developments, and emerging technologies, a number of draft guidances have become outdated and therefore, should be withdrawn.

No further explanation is provided for the individual guidances listed.

Ad-promo professionals will be surprised to see the Disease Awareness Guidance on this list.* Since its publication in 2004, poring through this guidance has become a rite of passage for ad-promo professionals. The guidance itself has always been something of an odd bird in that it sets out a category of communications over which FDA does NOT have authority.

The basic idea is that FDA has authority solely over the communications that promote or provide instructions for use of drugs. FDA does not have authority over all other communications. Sometimes, companies are cited by the FDA for engaging in communications that the FDA deems to have been product promotion but which the company itself clearly intended to be some other form of communication.

This guidance sets out many of the criteria that FDA identified in 2004 as crossing the boundary from non-regulated to regulated speech.

Based on the limited information in the Federal Register, there's no way to know why FDA has chosen to withdraw this specific guidance document.

It is worth noting that there is not currently anything on the CDER Guidance Agenda that touches on this topic, so it appears that people promoting prescription drugs will be left without any guidance about what FDA considers inappropriate in this area.

* I'm posting this guidance on my own site because I'm assuming that FDA's site will no longer host the guidance as of May 6, 2015. My sharing this document should not be construed as endorsing the views set forth in it, nor should it be taken as a sign that these views represent FDA's current position. This link is merely being provided for historical research purposes.

Why professional associations matter

The following remarks were delivered to the Temple University QA/RA program during their 2015 career night. I'm providing here the prepared remarks, which differ slightly from what was actually presented.

I’m Dale Cooke, the president of PhillyCooke Consulting, which is an FDA regulatory consulting firm that helps pharmaceutical companies and technology platforms make information about FDA-regulated products available via new and emerging technologies.

I also serve as the co-chair of the local Regulatory Affairs Professionals Society (RAPS) chapter, and it’s in that capacity that I’ve been asked to speak to you.

Specifically, I’ve been asked to speak about the importance of professional society involvement in your ongoing career development.

So, here it is: It’s really important to be involved in professional societies.

Seriously.

What’s in it for you?

Well, first, you get to meet other people outside of your specific company. The value of having those contacts is very high. I like to say that when you hire someone you’re also hiring their Rolodex.

For those of you who have never heard of a Rolodex, it’s a mid-20th century technology, kind of like an offline LinkedIn.

And the reason you want to hire someone’s Rolodex is that no matter how talented you are, there’s always something you don’t know. There’s nothing wrong with that. It’s just a fact of life, and when you’re facing that area where your own knowledge is lacking, it’s important to be able to reach out to other people who can help. Not to mention that at some point, you hope your company will be expanding, and when you do so, the first place you turn is your (and your team’s) Rolodex to look for more talent.

So, professional societies are an important means of extending your brain to tap into the larger community of professionals who also work in your field.

Second, professional societies keep their membership up to date on the latest developments. If you’ve been paying attention to the news, you’re certainly aware that Congress has been completely gridlocked and absolutely nothing is going on in Washington…except for FDA.

In the past few years, there have been several landmark pieces of legislation passed to address issues such as the supply chain, compounding pharmacies, and generic drug development, just to point out a few items that are near and dear to my heart.

Two days ago, new draft legislation that would drastically overhaul the FDA was released. I don’t know whether it’s going to pass, but if it does, I’ll be turning to RAPS, the Drug Information Association, and Food & Drug Law Institute (I’m an active member of all three) to find out how it affects me, my job, and my clients.

For example, next week, the local RAPS chapter is hosting an event with Jay Crowley, the godfather of UDI, about how the Unique Device Identification system is being implemented. This is a massive challenge for medical device manufacturers (i.e., some of the people you might be working for).

So, perhaps there’s some value for you in learning about it. Maybe?

By the way, if you want more information about the event, stop by our table to pick up a flier.

Finally, actively participating in professional societies enables you to demonstrate to your current and future employers your commitment to your career. It looks good on your resume.

If on a Thursday night, you choose to go the Maggiano’s in King of Prussia to hear Jay Crowley speak about UDI, instead of playing Quizzo at a local watering hole, then you’re showing how highly you value staying at the top of your game in your chosen career.

And serving actively in your local chapters is a further demonstration of that commitment. I always say that if you have two hours a month to volunteer with RAPS, then I’ll find a way to have you help the chapter in those two hours. If you have 10 hours, we’ll give you an award.

In addition, actively participating is fun. If I weren’t involved with RAPS, I’d never have met Linda Bowen [Editor's Note: Linda was in the audience], and Linda’s a hoot.

So, my advice to you is to get involved with at least one (and preferably several) professional societies. They’ll help you expand your network, stay on top of the latest developments, and demonstrate your commitment to current and potential employers, all while having some fun.

New 21st Century Cures Act Removes Social Media Provision

The House Energy and Commerce Committee have released a new draft version of the 21st Century Cures Act, which would significantly change how the FDA operates.

An earlier version of this bill included a provision that would basically have written a version of the one-click rule into law and required FDA to

"review each regulation and guidance that applies to the dissemination by means of the Internet (including social media platforms and character-limited applications) of information about medical products" and "treat hyperlinked information ... as if the information" were part of the initial communication.

In essence, Congress was mandating that FDA permit some version of the one-click rule, and revise or withdraw all guidances and regulations that prevented them from doing so.

This language has been completely removed from the latest draft legislation. I haven't seen any coverage of why this provision was dropped, and I was never able to determine where the initial language came from.

So, for now, the idea that legislation will drastically alter the landscape for using social media has taken a set back. But once draft legislative language is out there, it tends to crop up again and again.

Using Periscope for Regulatory Updates

Twitter released a new app a few weeks ago called Periscope. Periscope enables users to broadcast live from their mobile devices. Depending on how the broadcast is shared, you can either make the broadcast available to everyone or only a select few people.

I've been playing around with Periscope to get a feel for how people are using it and also to see what if any interesting regulatory issues it raises.

It's possible to create a distinct identity on Periscope from your Twitter identity; however, I'm using Periscope as @PhillyCooke.

One way I've seen Periscope be adopted by the larger non-pharma community is to provide additional "behind the scenes" footage from television performers, specifically people who host interview programs. I've also seen it used successfully for Q&A sessions because viewers can type responses, feedback, and questions into the app, and those comments are then seen by everyone viewing the broadcast including the presenter.

Next week, I'll be broadcasting the Philadelphia RAPS chapter meeting. We're having Jay Crowley speak about UDI.

Jay spent more than 25 years at FDA and is widely regarded as the godfather of the Unique Device Identification system, so we're extremely excited to have him speak. Another chapter chair asked whether we could turn the event into a webinar or otherwise make Jay's talk available to a wider audience, and that's when I decided to leverage Periscope.

So, start following @PhillyCooke on Periscope, and tune in next Thursday, May 7, at 6:30 to listen in to Jay's talk.

Brief Summary Guidance Digital Application

Five Things to Notice About FDA's Electronic 2253 Filing Guidance

Today, FDA produced its long-awaited guidance of submitting promotional materials electronically.

As ad-promo guidances go, this is a hefty one, weighing in at nearly 40 pages. For comparison, last year's two social guidances released on social media guidance day totaled 30 pages combined.

Rather than trying to provide a comprehensive digest of the guidance, I'm going to here provide a framework for understanding the guidance and point out some the items that leapt out at me on a first reading.

1. What is this guidance about?

Up till now, FDA's two primary groups responsible for overseeing the promotion of prescription drugs and biologics, the Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research (CDER) and Advertising and Promotional Labeling Branch (APLB) in the Center for Biologics Evaluation and Research (CBER) have had different policies about accepting electronic filing of promotional materials. APLB accepted them; OPDP didn't.

Moving forward, both agencies will accept promotional material submissions electronically, and they will do so using the common eCTD format used for all other electronic submissions, such as NDAs and BLAs.

2. Which submissions are affected?

This guidance affects only submissions of promotional materials to the FDA, and such submissions are either voluntary or mandatory. All promotional materials for any prescription drug must be filed with FDA at the time of initial dissemination or publication (though see here for an important exception regarding social media). In addition, a small class of products (call subpart H or E) have additional mandatory submissions.

In addition, companies sometimes request voluntarily that FDA provide feedback (so-called advisory comments) on draft promotional materials. Companies do so to minimize the likelihood of receiving an FDA enforcement action, since the worst situation a company can find itself in is having spent money to develop promotional materials only to have FDA take enforcement activity that requires the company pull the existing materials and lose the time and money of creating all new materials. Voluntary submissions of promotional materials primarily include requests for advisory comments from the FDA on a newly approved product in its launch phase, TV spots, new messaging, or perhaps as a result of previous enforcement activity.

Because all submissions of final samples of promotional materials include a completed copy of Form 2253, these submissions are typically referred to as 2253 submissions. Though note that APLB requires that companies include Form 2253 for voluntary submissions of draft materials for advisory comments; and that difference will continue even in the new eCTD submissions as proposed in this guidance.

3. Guidances are usually voluntary; but this one isn't (sort of)

Right now, everything in this guidance is voluntary; and the guidance itself is in draft status. There is no requirement that any company begin adopting the procedures set out in this guidance today.

HOWEVER, after this guidance is finalized by the FDA, then parts of the guidance (the parts addressing mandatory submissions of promotional materials) will become mandatory 24 months later.

So, even after the final guidance is released (and there's no way of knowing when that will be), only parts of this guidance will represent mandatory changes; but the mere fact that some parts of the guidance are mandatory is itself a significant difference from most other guidances.

4. But aren't TV spots required to be submitted for review 45 days prior to use?

No. PhRMA's guiding principles on DTC television advertising recommends that companies submit them to the FDA with sufficient time for FDA to review them, but this is not a regulatory requirement. It is only binding on PhRMA signatories, and even then, the companies are not required to submit the materials for advisory comment, just to give FDA time to comment, should the Agency choose to do so. 

Also, FDASIA granted FDA authority to mandate that TV spots be submitted to FDA 45 days prior to airing for FDA to comment, and FDA issued a draft guidance about how it would implement such a program. However, as this new guidance states repeatedly, that guidance has not yet been implemented, and FDA does not want companies to follow those procedures currently. The process itself is deeply problematic, as I pointed out in an appendix to my primer on the topic.

5. Is there any glaring change from current 2253 submission processes?

This guidance provides far more extensive discussion of the submission of promotional material than previous direction. Most of the discussion will sound familiar to ad-promo professionals. One item that leaps off the page in the section on final samples submission is this passage:

Firms are also encouraged to submit annotated versions of the promotional material(s) cross-referenced to the product labeling and references, if applicable. (page 6)

Standard final samples submissions do not include references, and this "encourage[ment]" appears in a section of the document that otherwise will cover mandatory changes. Adopting this change would be deeply problematic for most promotional materials.

In the standard review and approval process, the references are only included for the initial medical legal regulatory (MLR) review, and then deleted from subsequent check-changes, and final samples submissions to the pharmaceutical company. Adding references back for the final 2253 submission would create significant additional expense, and would create additional possibility for error during the most time-sensitive portion of an elaborate process. 

New Video Lecture Available

The Digital Health Coalition, where I serve as one of the Digital Scholars, has created a new online resource called the Digital Health Coalition Academy. At this online destination, they are providing a series of short videos about topics of interest to people working in the digital health space.

I am pleased that they asked me to create one of the inaugural presentations. I chose to update and slightly expand on the presentation I previously delivered at the FDLI enforcement conference. 

I've previously asked on this blog how much value people get from the slide decks I post on SlideShare when there's no corresponding audio because I sometimes post unaltered decks that were not created as standalone pieces, but were intended to be accompanied by my narrative.

I've also previously declared my intention to start making more video content available, and though this presentation isn't on my YouTube channel, which remains woefully inadequate, I hope the DHC partnership will jump start that process.

Please provide any feedback in the comments or privately about whether you find the presentation useful, especially whether it was significantly more valuable than just the slides alone on SlideShare.

DIA Marketing Pharmaceuticals Wrap-up

As I mentioned in a previous post, I led a panel on Leveraging Innovative Technologies at this year's Drug Information Association's Marketing Pharmaceuticals conference.

In general, DIA only makes the slide decks available to attendees; however, presenters retain ownership of their decks, so I also post mine on SlideShare, and this year, I've done the same.

I always wonder how much value people get from a deck like this one. It wasn't designed to be a standalone read. Instead, it very much was intended to be accompanied by my commentary. The essential points I was trying to make to attendees were that:

1. Mobile is no longer fringe for people consuming health information
2. Device proliferation and interaction is real. Your content is just one node in a larger ecosystem.
3. Phone/phablets keep getting bigger (which fuels further consumption and makes supplying all of your information easier)
4. However, although the phone footprint is bigger the proliferation also means people are interacting using other interfaces, such as voice recognition and spoken responses.

The rest of the panel comprised representatives from Twitter and YouTube, talking about how they are making their platforms available and what people are doing, and then Johnson & Johnson and AstraZeneca discussing how they're leveraging these platforms and ensuring compliance.

I had a great time, and the audience asked a lot of good questions and was very engaged.

Aside from the panel I chaired, there were many great sessions. You can get a feel for the conference by checking out my Twitter feed. The conference hashtag was #DIAmp.

This conference is one with significant FDA participation. From my perspective, some of the highlights from FDA's presentations and panel discussions included:

1. FDA reiterated with exactly the same slide as at September's Food and Drug Law Institute's Advertising & Promotion conference the points about Reminder-like advertising. There was no change. This further affirms that this category is well-established in FDA's eyes and should not be regarded as suspect by industry. 

2. In oral statements, there was some language on the desirability of mentioning serious risks in the link from Reminder-like advertising. Specifically, the link to the PI (which is required for reminder-like ads, but not for reminder ads) should mention that there are serious risks with the product. See my live Tweet, which is of course not a transcript.

3. The seemingly perennial question of repurposing TV spots on Hulu came up again. Repeatedly, I have heard FDA panels receive this question, and every time, FDA says something along the lines of "If it's compliant on TV, then it's compliant on Hulu." (See here for example.) Yet during this conference, the response was phrased differently. The emphasis in the response was in the narrow definition of a broadcast ad in the regulations and that Hulu is allegedly outside that definition. 

4. Finally, there was lots of discussion about the brief summary guidance. FDA did clarify that they will accept using the full PI and/or PPI in lieu of developing the new consumer brief summary document. That point had been included in the previous versions of the guidance explicitly but was eliminated from the latest version; however, FDA is strongly encouraging companies to adopt the newer recommendations instead. As the FDA speaker said, "That [using the full PI] would make us sad."

Upcoming Speaking Engagements

The conference season starts up in February, and I have a few engagements (listed in the right hand column as always) coming up. If you follow this blog, then keep in mind that I sometimes have discounts available and will send you the info if you register for updates or send me an email using the form that is also in the right hand column.

First up on Tuesday, February 10 is a webinar I'm delivering with LSTI on the current state of social media guidance. This is an updated version of the webinar that I presented in the fall on the same topic. Since that initial presentation, the comment period has closed on the two social media guidances from last summer (though of course, it's always permitted to send comments even after the docket is closed).

The following week on February 18-19, I'll be leading an exciting panel on leveraging innovative technologies at DIA's Marketing Pharmaceuticals conference. Here's the official description of the conference:

The importance of understanding the complex regulations regarding the marketing of pharmaceuticals, veterinary products, biologics, and medical devices has never been higher. The DIA Marketing Pharmaceuticals 2015 conference will explore drug and device marketing in an evolving environment while serving as a vital forum for all stakeholders involved with the marketing, advertising, and promotion of a wide range of health care products.

Featured Topics:

• Latest enforcement actions and policies issued by the FDA
• Leveraging innovative technologies compliantly
• How other companies are complying with government regulatory requirements
• Best review and approval practices with industry colleagues
• Novel promotional tactics trending in the pharmaceutical industry 
• Emerging issues in the oversight of marketing materials

The panel I'm leading will feature participation by AstraZeneca, J&J, Twitter, and YouTube. Here's the description from the conference webpage:

Consumers and health care professionals rely on the Internet and their mobile devices as essential tools for finding information about health care, medicine, and other treatment options. Makers of prescription products have been lagging behind in the uptake of these tools. This session provides the hands-on experience of some of the people who are leveraging YouTube and Twitter at the time and in the platform that people are using.

You can see the full conference agenda and get registration information here.

The week of February 23 will see me back in DC for the final session of the ACDRS program. This is something I started doing last year and really enjoy because of the intimate classroom setting of working with a group of professionals who have spent more than a year following the development of prescription drugs and studying the regulatory requirements. It's an intense program, and I speak in the final session dedicated to commercialization and (no surprise) the need to understand and leverage new and emerging communication channels.

Before that travel gets started, I'll be attending the local Philadelphia RAPS chapter meeting next week on Thursday, January 29. Gary Buehler from Teva Pharmaceuticals will be speaking about the Citizens Petition process and ways companies use it to delay introduction of generic versions of products. Gary spent nearly 10 years at FDA's office of generic drugs before moving over to Teva four years ago. It should be a great topic, and I hope you'll join.

But whether you're also in the Philadelphia area, will be traveling to one of these events, or joining a webinar remotely, please stop by or drop a line and say hello.