Recap of FDLI #AdPromo2023

Disclosure: I sit on the Planning Committee for the FDLI Ad-Promo conference. This is an unpaid, volunteer position. The contents of this post were not discussed with or influenced by any member of the FDLI staff.

This post provides some of the highlights from FDLI's ad-promo conference. An on-demand version of the conference presentations is available at: https://www.fdli.org/2023/11/advertising-promotion-for-medical-products-conference-on-demand/

The Food and Drug Law Institute's (FDLI) Advertising & Promotion for Medical Products conference wrapped up last week. I attended the conference and also moderated a panel on data privacy and concerns about the use of health data for the targeting of advertising.

The first day kicked off with a fireside chat with Arun Rao from the Department of Justice (DOJ), Lauren Roth from the Food & Drug Administration (FDA), and Serena Viswanathan from the Federal Trade Commission (FTC), led by Christine Simmon of FDLI.

FDA and FTC both noted their recent guidance updates. For FDA, that means the new Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers Guidance for Industry (SIUU) and the newly finalized Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements. 

FTC has also been busy, providing updated guidance on endorsements, reviews and testimonials, and a distinct Health Products Compliance Guidance.

DOJ, FDA, and FTC also mentioned the extent to which they are still very much digging out from the backlog created by the pandemic. More than three years after COVID-19 first came to our shores, its effects are very much still being felt.

Rao also mentioned a new policy from DOJ to create a safe harbor for self-reported disclosures made in connection with a merger or acquisition. Under this new policy, companies that learn of wrongdoing at a company they have acquired can be protected from later liability if they report the wrongdoing to DOJ within six months of closing the merger or acquisition. This is as Rao described it a "very big juicy carrot" to encourage self-reporting of wrongdoing, and it also ramps up the need for effective due diligence during the M&A to ensure that all wrongdoing is uncovered and can be reported.

One final point mentioned by Roth is the importance to FDA of combatting misinformation about medical products. Commissioner Califf has repeatedly warned about the need to combat misinformation, and it is not a stretch to see FDA's SIUU guidance as one small step in that direction. By providing further guidance about exactly how sponsors can share truthful, not misleading information about unapproved uses, FDA is enabling efforts to get good information from the people who should be seen as the most reliable source of that information, the product's sponsors.

The next session of the day included an update from OPDP, APLB, CDRH, and CVM related to advertising and promotion.

Katie Gray from OPDP gave a detailed presentation on the Recorlev enforcement action from earlier this year and an overview of the SIUU guidance. Lisa Stockbridge from APLB provided a reminder on reminder advertising, indicating that this well-established category of communication continues to cause firms difficulties. Debra Wolf of CDRH emphasized that although there has not been a significant amount of publicly available enforcement actions from CDRH, the Agency continues to have many private communications with firms about their marketing efforts.

The next plenary session covered scientific exchange and pre-approval communications. Elisabethann Wright of Cooley provided particular insight into the EU's approach, which of course varies widely by country, and has been especially active on platforms such as LinkedIn. Of note is the extremely active role played by the industry's own associations in not merely promulgating guidance and establishing codes of conduct but in regularly enforcing violations of those codes against member companies.

After lunch, the first set of breakout sessions occurred including the panel I moderated on data privacy. I found the discussion very lively and enjoyed hearing from Elisa Jillson from the FTC, Lyra Correa from HHS's Office of Civil Rights, and Nancy Perkins from Arnold & Porter. I have previously opined that the 2020s will be most known for its focus on privacy, and while the cookie-less future we keep hearing about gets pushed back once again, there's growing awareness and concern about how much deeply personal information has been given up and on how companies are using (or misusing) that data.

Simultaneous sessions looked at the recently finalized guidance from the FDA on Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements while another session looked more into the promotion of veterinary products. Because I was leading another session, I couldn't attend either, but I'm looking forward to using that link provided earlier to view the recordings. 

The afternoon plenary sessions resumed with a look at FTC's role in enforcement of healthcare advertising and closed out with a session on that perennial chestnut of social media usage.

Day two of the conference kicked off with an enlightening discussion of so-called CFL (Consistent with FDA-Labeling) claims. Torrey Cope of Sidley Austin provided an insightful look not just at FDA's enforcement post-guidance for claims that failed to meet the CFL standard, but also for taking the time to examine the nature and wording around the acceptance by FDA of so-called Real-World Evidence (RWE) in the context of product approvals. RWE is not the sole source of CFL claims, but Cope was able to provide some valuable lessons.

The afternoon's breakout sessions included one on artificial intelligence (which I attended), promotional challenges in rare disease treatments, and navigating accelerated approval promotion.

The closing session focused on other avenues for enforcement, including of course, the Better Business Bureau National Advertising Division's (NAD), as well as general counsel to general counsel complaint letters, filing complaints with the FDA, and perhaps even bringing a Lanham Act case.

The NAD's finding against Novartis earlier this year was of course a hot topic. But it is worth noting that in a more recent case, Viiv simply declined to participate in the NAD process. NAD referred the matter to FDA and FTC noting that decision, but as of the writing of this post, no further action by the government has been seen.

Alan Minsk of Arnall Golden Gregory noted the importance of determining your goal when looking at the appropriate path. If your goal is get a competitor in trouble then you really need to rely on the government or the courts, but if your goal is primarily to just get the company to stop the use of misleading promotion, then NAD or a direct complaint letter might be a far more cost-effective solution.

Overall, the conference was a huge success, though my opinion should be viewed as biased because I sit on the conference planning committee. FDA is definitely digging itself out from the pandemic backlog. I fully expect we'll see more from the Agency, as a very active 2023 has already demonstrated.

COVID-19 & Ad-Promo

The COVID-19 pandemic has brought to the fore some issues of ad-promo for FDA-regulated products. I'm posting here to highlight some developments and correct some of the discussion.

Snake Oil & Enforcement

One of the unfortunate things about any new health concern is that the snake oil sales start immediately. There are far too many scumbags who see an opportunity to profit in a crisis. The COVID-19 outbreak is no exception.

These people represent a real danger to the public. People who promote unproven treatments can convince the public that they don't need to take the outbreak seriously, can lead to reckless behavior, and in the extreme can contribute directly to increased deaths as their victims rely on the snake oil instead of trusting healthcare providers.

In this setting, FDA and FTC enforcement is essential. We need vigorous enforcement from the authorities to stop the spread of misinformation. I'm glad to see FTC and FDA have already taken some action in this regard. I hope we'll see more.

Off-Label Promotion & Outbreaks

Researchers, practitioners, and industry are frantically searching for any effective treatments. Currently, the science is unclear about whether any treatment works.

As I write this, there has been a lot of buzz around the possible effectiveness of an anti-malarial treatment, hydroxychloroquine sulfate. This is an already-approved drug being used for an unapproved indication, i.e., this is a classic off-label use of a product.

I have seen some misinformation in the media about off-label uses of products, so I thought it might be helpful to set out the background to all of this.

To bring a new drug to market, a company must submit a New Drug Application (NDA) to the FDA. Among other information, the NDA includes proposed labeling. The proposed labeling provides directions to healthcare providers explaining how to use the drug safely. That labeling sets out the proposed uses of the drug. The uses of the drug are known as the indications. Indications typically include a population, a condition, and the stage/severity of the condition (if applicable).

The FDA evaluates the NDA to determine whether the sponsor has demonstrated that the drug is safe and effective for the proposed indications. Assuming the sponsor meets the evidentiary burden, the FDA approves the proposed indications for the product.

After being approved by the FDA, sponsors may only promote their drugs for the specific indications approved by the Agency. Any other use of the product is "off-label" use.

Off-label use is NOT inherently bad, wrong, or evil; and off-label use of a drug is also not prohibited. The other evening I heard a television news segment where the expert commentator spoke of using drugs in violation of FDA's rules. That's wrong.

FDA does not regulate the practice of medicine, and physicians are, for the most part, able to prescribe drugs as they believe is appropriate to treat the patients they see.

But the sponsors are not permitted to promote their drugs for any uses other than those approved by the FDA. Importantly, there is no explicit prohibition in law against the promotion of unapproved uses. You won't, for example, find off-label promotion listed as one of the items that causes a drug to be misbranded. Instead, there are multiple legal theories about this prohibition and what exactly makes such promotion illegal, including the failure to include adequate directions for use in the labeling.

FDA has made it clear that it sees the continued prohibition of off-label promotion as essential to protect the public, despite some adverse judgments by some courts.

If a company learns of a new off-label use for a drug and wants to promote the drug for that use, the sponsor must conduct additional clinical trials to demonstrate that the drug is also safe and effective for that new use. After completing the clinical trials, the sponsor submits an sNDA (supplemental New Drug Application) to the Agency.

Assuming the Agency approves the sNDA, the label is updated to include the new indication, clinical trial data, additional instructions for use, etc., and the company is then able to promote the new use of the drug.

So, FDA doesn't have to DO anything to make the possible off-label treatments available, despite several prominent people calling on FDA to take action. The drug being suggested for off-label use is already on the market and can be used for this off-label use.

Why doesn't FDA simply approve the new use?

Because FDA doesn't know if the drug works.

When FDA evaluates an NDA or sNDA it weighs the risks and benefits of the drug for each specific proposed use. As FDA has repeatedly made clear, each specific proposed use requires a separate risk-benefit determination.

It is possible (even likely) that a drug that has been proven to be safe and effective for one use might not be either safe or effective for another use.

Indeed, one frequent criticism of off-label use of drugs is that there simply isn't sufficient evidence of effectiveness for many off-label uses.

And that in turns leads directly to why FDA's prohibition on off-label promotion is so important to protect the public health. Using treatments without evidence and promoting such treatments can make things worse.

FDA has the tools to act rapidly to approve new uses of a drug, but it is unwise to short-circuit the approval process, and it's irresponsible to hype an off-label use without sufficient evidence to demonstrate its efficacy.

COVID-19 Outbreak Pausing Live Speaking Engagements

I live in Pennsylvania, just outside Philadelphia, in Montgomery County. Currently, Montco is the worst hit county in Pennsylvania for the COVID-19 outbreak. Consequently, the governor ordered all non-essential businesses to close more than a week ago in Montco, and yesterday expanded that order statewide.

Because most of my work is from home, the outbreak has not yet affected my ability to provide client service; however, for the foreseeable future all live speaking engagements are cancelled.

I was scheduled to deliver the device workshop at DIA advertising conference last week and also had some workshops scheduled with FDAnews for May and June. DIA's conference was been delayed with a decision about how to proceed still to be determined. I'll post an update here when I know more.

The May FDAnews workshop has been cancelled, and the June workshop is on hold. When I know more, I'll post an update.

In addition, I am part of the leadership committee for the Philadelphia RAPS chapter. We held our last event on March 5 at Temple University, and the next day, RAPS HQ sent out a notice asking chapters to hold off on live meetings for March and April. Currently, the chapter leadership is discussing other options, such as webinars to continue getting information to our membership during the outbreak.

While we adjust to life during a pandemic, I'll provide updates as I can. Stay safe and wash your hands!

2020 CDER Guidance Agenda Released

UPDATE: The guidance mentioned below was released. Here's the link.

The FDA has released the CDER Guidance Agenda. For ad-promo professionals, the most most significant item is the inclusion of an item labeled:

• Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products--Questions and Answers 

Also notable is that no other advertising or promotional guidances are listed. The draft guidance on presenting risk information turned 10 years old last year. It seemed ripe for an update and perhaps even finalization. That seemed even more likely in the context of OPDP's study of the so-called one-click rule. That study was first announced in 2017. There's no update on the FDA website about the study, but I expected it to be completed last year.

FDA's social science research has clearly been influencing recent guidances, so I assumed (and continue to assume) that FDA would want to update the risk presentation guidance in light of its most recent research about presenting risks, including the one-click study. Apparently, we'll have to keep waiting.

BTW, for those interested in the topic of biosimilar promotion, the Drug Information Association's Advertising & Promotion Regulatory Affairs Conference will have a session covering this topic. Full disclosure: I sit on the programming committee for the conference and will be leading the medical device primer the day before the full conference kicks off. 

Temple RA/QA Advertising Course

It was just confirmed that I'll be teaching in Temple University's RA/QA MS program this spring. Specifically, I'll be teaching the ad-promo course.

If you or anyone you know is interested, please reach out to me for information. The course will be taught out of the Fort Washington campus, but online enrollment is permitted.

Here's the complete schedule of classes for the spring.

DHC Privacy Post

The Digital Health Coalition asked for my views on the renewed emphasis on privacy for pharmaceutical marketers. I shared a few thoughts here.

Expanded Service Offerings

PhillyCooke Consulting has added new services from the humble start more than five years ago, when I used to joke that the company included both me and my laptop.

In addition to continuing to provide regulatory consulting services, PhillyCooke Consulting now offers:

• Submission Preparation Services for Ad Agencies
• Medical Editing
• Proofreading, and 
• Medical Writing. 

You can learn a bit more about the expanded services here, or simply complete the "Contact Form" to request a free initial consultation.

Also, having completed law school (and been admitted to the bar in Pennsylvania), I am now able to offer legal services; however, the law practice is distinct from PhillyCooke Consulting. If you are interested in legal services related to the advertising and promotion of FDA-regulated products, please see FDAadLaw.com, which is a sister corporation to PhillyCooke Consulting.

Although the website is currently a bit spartan, the services offered are robust and address all aspects of advertising FDA-regulated products, including concerns related to the Lanham Act, privacy, and FDCA issues.

Preparing for Pricing in DTC TV

UPDATE 2: On August 21, 2019, the government filed a notice of appeal in this case.

UPDATE: On July 8, 2019, the judge in the pending litigation described below issued an order setting aside the CMS rule. The full opinion is available here.

If nothing changes, the new rule about including drug pricing in TV ads from CMS will go into effect one week from today on July 9, 2019.

There are a few wrinkles to keep in mind as we approach this deadline. First, there's a lawsuit pending that could delay the rule's implementation. Second, the operational challenges of abiding by the rule are the biggest hurdle including the expanded 2253 filing requirements. Third, the rule's scope is still unclear. Fourth, the rule doesn't preclude or preempt the PhRMA Principles change from April. Finally, the overlapping but non-identical scope of the rules could lead to some confusion and compliance hiccups. This post addresses each of these points in turn.

Pending Litigation

As I noted in a previous post, several pharmaceutical companies along with the Association of National Advertisers filed a complaint seeking to overturn the CMS rule. The full complaint is available here. The plaintiffs have filed a motion to stay the rule's implementation, and the judge has set a date of July 8 for issuing a decision. So, it is possible that companies will not actually be required to include their drug pricing in TV spots on July 9; however, as a practical matter, companies airing spots on July 9 and soon thereafter have most likely already developed them with the required pricing information included. 

All promotional materials for prescription drugs, biologics, and vaccines must be submitted to the FDA at time of initial dissemination or publication, so the FDA has most likely already begun receiving submissions of TV spots that include the information, and it is unlikely that a company would go to the time and expense of producing two versions of their TV spots (one with the pricing and one without) and submit both the FDA, only to determine on July 8 which spot to air the next day. Consequently, even if the judge issues a stay on the rule, there's a good chance that you'll see at least a few TV spots featuring pricing on July 9.

And that points to one of the issues the rule raises: operational challenges.

Operational Challenges 

Adding a line of copy to a TV ad is not a massive creative endeavor, and because the rule only requires the copy to appear on screen for a long enough time to be read, there are no audio implications, but the CMS rule requires that the pricing information presented is kept up to date. Specifically, the new rule requires that the pricing information provided be:

"as determined on the first day of the quarter during which the advertisement is being aired or otherwise broadcast." 42 CFR 403.1202 (not yet live on the code of federal regulations itself).

That means the pricing information must potentially be updated every quarter. Of course, most companies don't change their drug pricing quarterly, but it is common to have pricing updates twice per year. So, every time a company changes its pricing, it will have to determine what ads are currently airing and whether the pricing updates affect those ads. If the pricing changes affect the ads, then the ads will have to be updated. An updated TV ad both means an expense for the advertiser, but it also means a new 2253 filing with the FDA because updated materials must be resubmitted to the Agency.

And that means that the media buyers placing the ads will have one additional wrinkle to keep in mind as they manage the ad placements. They'll need to make sure that as new pricing comes into affect and ads are updated that the old ads are removed from the rotation, lest they be placed on CMS's naughty list.

That operational challenge is compounded by the fact that the scope of the rule is unclear, so it's not currently possible to say exactly what ads must include drug pricing.

Rule Scope Unclear

As I noted in a previous post, CMS made it clear that the requirement to include pricing does not apply to ALL direct to consumer (DTC) ads, but only to a limited subset of DTC ads. Specifically, the new requirement applies to only ads that appear on broadcast, cable, satellite, and streaming television. Unfortunately, CMS never explained what "streaming television" is. I tried to find a definition somewhere but wasn't able to do so. This matters because there are tons of DTC video ads that MIGHT be considered subject to the rule that are definitely not presented on "broadcast, cable, or satellite television."

Because of this scope unclarity, the operational challenges of managing ad inventory is compounded, and of course, companies must decide how to handle ads that are used on television when they appear in places where the pricing information is not required. It would certainly be easier to develop a version of the ad that doesn't require quarterly updates, but it also is easier to traffic fewer total ad units.

CMS Rule Adds to (Doesn't Replace) PhRMA's Pricing Requirements

The Pharmaceutical Research and Manufacturers of America (PhRMA) updated its Guiding Principles on Direct to Consumer Advertisements about Prescription Medicines in October of 2018. The most significant change was the addition of a requirement for television ads to include a destination where people can find pricing information about the prescription drug being advertised. This requirement became operative in April of 2019. All members of PhRMA are obligated to follow the PhRMA guiding principles, and most companies that are not members of PhRMA also abide by the guiding principles. Consequently, almost all television commercials currently airing include a link to a webpage with pricing information.

Adhering to the CMS rule does NOT meet the PhRMA guiding principles. Consequently, most companies will be providing both a link to a page with additional information and the pricing information required by CMS. We'll see how companies execute this, but my expectation is that a single screen at the end of a television commercial will accommodate both pieces of information.

Of course, not all ads are required to include both pieces (or even either piece!) of information.

Non-identical Overlapping Scopes

The new CMS rule applies to all advertised indications of a pharmaceutical product that are reimbursed via Medicare or Medicaid and whose cost is at least $35 per month (or for a typical course of treatment). 42 CFR 403.1200. Note that some drugs have multiple indications, where only some of the indications are reimbursed by CMS. For those products, only the ads that promote an indication reimbursed by CMS are required to include the pricing information; and only if the drug's list price is at least $35 per month (or for a typical course of treatment).

By contrast, the PhRMA guiding principles apply to all ads for prescription medicines regardless of whether the drug is reimbursed by CMS and regardless of the cost. Of course, the guiding principles are only binding on members of PhRMA and any non-member companies that have chosen to abide by the guiding principles.

TL;DR

Some commercials (but we don't know exactly which ones) might start having pricing information in one week. The addition of this information is allegedly going to address the allegedly high price of prescription drugs. The only guaranteed aspect of the recent changes from PhRMA and CMS is that marketing and regulatory operations groups are going to have challenges ensuring ongoing compliance, and the FDA is about to start getting more 2253 filings, including a likely surge of revised television spots in the next few days.

DTC TV Pricing Rule Challenged

SECOND UPDATE: On July 8, 2019, the judge issued an order setting aside the CMS rule. The full opinion is available here.

UPDATE: On July 8, 2019, the judge in this suit is due to provide a ruling on whether the rule will take effect on July 9. The judge might issue a stay on the rule's implementation. For more details, see this report from MM&M.

On June 14, 2019, Amgen, Merck, Lilly, and the Association of National Advertisers filed a complaint challenging the CMS rule requiring TV ads to include drug pricing information.

Here's a link to the original complaint: https://drive.google.com/file/d/1w5I5kvuYIedGaFGOYzl_VtzZEDFGA7vQ/view

If there is no action on this complaint, the rule will go into effect on July 9.

What is streaming TV?

Disclosure: This post discusses some Google products. I sit on the Google Health Advisory Board, and Google has been a client of PhillyCooke Consulting. Nothing in this post has been shown to Google or received the endorsement or approval of anyone at Google. I have not discussed the topic of this post with Google employees.

The Center for Medicare & Medicaid Services finalized a rule requiring some prescription drugs to include pricing information in some direct-to-consumer advertisements. Assuming the rule's implementation is not delayed by court challenges (which have been discussed extensively elsewhere), the rule will be effective July 9, 2019.

I've previously expressed my view about the likelihood of the rule coming into effect and the effectiveness of the rule should it be implemented.

This post, however, is about a different topic. Which ads does the rule apply to?

The scope of the rule is stated at the new 42 CFR 403.1200:

The rule will apply to all prescription drugs or biologics eligible for reimbursement via either Medicare or Medicaid that cost at least $35 per month or for a "typical course of treatment."

Later, at 42 CFR 403.1202, the rule states, "Any advertisement for any prescription drug or biological product on television (including broadcast, cable, streaming, or satellite) must contain a textual statement...."

Nowhere in the rule or the accompanying discussion does it provide any additional clarification about the meaning of television advertisements. Since the draft of the rule was released, some people have raised the question of what exactly "streaming television" is? (See, for example, this discussion published in October.)

This matters, of course, because prescription drug manufacturers will shortly be required to provide drug pricing in certain ads, and to update the ads quarterly with the latest pricing information. CMS made clear in its publication of the draft rule in October, that this requirement was limited. It does not apply to all advertising or even to all direct-to-consumer advertising. Instead, the draft publication stated, 

"We [CMS] considered whether this regulation should apply to advertisements that are in other media forums such as radio, magazines, newspapers, internet websites and other forms of social media, but concluded that the purpose of this regulation is best served by limiting the requirements to only those identified herein."

Clearly, this requirement is intended to be limited, but to know exactly what ads this requirement applies, we need to understand what "broadcast, cable, streaming, and satellite" television are. I know what broadcast, cable, and satellite television are; however, I am unclear on what "streaming television" is.

I researched the Code of Federal Regulations, the United States Code, the Federal Communications Commission website, the Federal Trade Commission website, and of course, the Center for Medicare & Medicaid Services website looking for a definition of "streaming television." None of these sources provide a definition for "streaming television."

The closest I found to an applicable definition is a discussion in an FCC report about competition in the video delivery market, though, even this discussion fails to define "streaming television."

Instead, the FCC report divides video delivery services into three categories: 

1. Television broadcasters (corresponding to broadcast television in the rule)
2. Multichannel video programming distributors (MVPD, corresponding to both cable and satellite television in the rule)
3. Online video distributors (OVD)

It's the last category--OVD--where there's discussion of streaming video services and the newer services that appear to blend features of "traditional" OVD and MVPD providers. Services such as YouTube TV (to which I subscribe), serve traditional broadcast television programming, cable programming, and other content. Nowhere does the FCC refer to any OVD provider (or any other video content provider) as "streaming television." The FCC refers to such providers as "virtual MVPDs." Perhaps, CMS intends "streaming television" to be coextensive with "virtual MVPDs." If so, they could not have been less clear.

Again, the question of what qualifies as "streaming television" matters because prescription drug marketers face a new obligation that clearly isn't intended to apply to all OVD presentations of advertising.  The draft of the rule made it clear that this requirement would not apply to all online platforms, such as Internet websites. Presumably, that means that advertisements on YouTube.com are not required to include drug pricing information. Determining the scope of the application of this new rule will have a significant impact on prescription product advertisers because ads falling within its scope will need to be updated at least quarterly to remain compliant with the CMS rule.

There are, of course, many OVD platforms that might qualify as "streaming TV" but that clearly are not "virtual MVPDs." Netflix, Hulu, individual cable and network apps, sporting leagues apps (such as MLB TV), and services such as Amazon Prime provide content that is often referred to as television. 

Presumably, CMS's published lists of advertisers who are failing to comply with the rule, once available, will provide some clarity, as we learn through its own actions how CMS is interpreting this vague and undefined new category of communication. Until enforcement begins, marketers will largely be making decisions in a vacuum about what ads fall within the scope of this new rule.

"New" Means within the Past Six Months

During the Q&A of a presentation at the AdvaMed Advertising and Promotion of Medical Devices conference (slides here), I was asked why I claimed that the word "new" meant within the past six months. I mentioned that FDA had a post noting this and that FTC also had the same position.

On the train home, I decided to hunt down the sources, and this post is the result so I don't have to duplicate the effort again. I didn't realize that FTC's position on the issue went back to 1967.

I still don't think drug ads will include pricing any time soon

So, I was right!
...

Or maybe I was wrong.
...

Or perhaps the jury's still out.

In May, when President Trump released his blueprint for lowering prescription drug pricing, I wrote a blog post saying that I didn't see how FDA had authority under existing regulations to mandate the inclusion of prices in the direct-to-consumer (DTC) ads. I further claimed that getting such a requirement in place would either require a new regulation, or more likely new legal authority.

Well, as some of you might have heard, yesterday, the Trump administration released a new proposed rule that would require pharmaceutical companies to include the Wholesale Acquisition Cost (WAC) in television ads.

I'll have much more to say about this proposed rule as the conversation continues. And I can't decide which verdict to make on my earlier prediction.

I want to make one point here that hasn't been mentioned in any of the coverage I've seen so far.

Too frequently people talk about prescription drug advertising in a vacuum. The assumption seems to be that people know absolutely nothing about anything and on to this tabula rasa the promotions from pharmaceutical companies are forced, brainwashing people into storming their doctors' offices to demand prescription drugs.

That's not true. Not even close.

People care about their health. They care about the health of their children, their parents, their spouses, and others. When they have a health issue, they start looking for information about ways to treat that issue, ideally to cure it, or at least to help mitigate the symptoms and severity of the condition.

Their search for information will (I hope) include an investigation of whether a prescription treatment is the right option, but it will also include the crap that's sold on disreputable websites. Their search will include supplements, with all of the appropriate concerns.

This is relevant to the debate about drug pricing because one reason prescription drugs cost much more than these other options is that they work. We know they work because the FDA has evaluated the science behind them and believes that there's good reason to believe they work.

The other reason they're more expensive is because most people have some form of prescription drug coverage from their insurance, and insurance companies are willing to pay far more to keep their policy holders healthy than most consumers are willing to pay out of pocket.

Throughout the CMS's proposed rule, there are repeated discussions about how information about the WAC will enable consumers to make rational decisions about treatment options. The assumption seems to be that consumers are limited solely to trying to decide between prescription drug A and prescription drug B and that knowing the WAC will somehow enable them to make a better decision between the two. All by itself, this is a deeply suspect proposition.

But the more important point I want to make now is that people aren't trying to decide between prescription drug A and B. They're also considering pseudoscience crap C and possibly dangerous supplement D and over-the-counter treatment E and loads of other options as well.

Currently, people don't know how much prescription drugs cost, and maybe that's a good thing because it keeps people from comparing that $84,000 prescription drug to the $75 pseudoscience product. Acting as if the price is the sole, or even the primary, factor that consumers should use to evaluate treatment options ignores that most of the evaluation doesn't occur purely among different prescription treatments, and it also rarely involves a qualified health care professional.

It's most often a person, maybe a family, alone, or talking with their friends trying to figure out what's wrong and how they can fix it.

The response to including pricing in prescription drug ads could be, as I've said repeatedly, that people are scared away from prescription drugs that would be relatively affordable for the individual.

It also could be that the crap starts getting more expensive. After all, if people grow accustomed to seeing health treatments advertised with a list price of $100,000 or more, then they won't necessarily notice that the item being advertised is a dangerous supplement or pure pseudoscience.

I've noticed over the past few years that more and more ads for supplements have started mimicking prescription drug advertising. They make their logos look like prescription drug logos. They include a risk statement in their ads. To someone who isn't trained in knowing the difference, you could be forgiven for thinking there's no difference between these products and prescription treatments.

Is it really a stretch to think that requiring prescription treatments to include prices will result in those pseudoscience products doing the same, or to worry that the prices they start seeing as their comparator is the now revealed price of the prescription treatment?

On Bending the Cost Curve & MACRA's Flaws

I'm taking advantage of my law school education to write about issues that are related to my work, but sometimes a bit afield of the strictly limited area of FDA regulation of advertising and promotion. Whenever I have something that I think might interest the readers of this blog, I'll post the piece to my Scribd.com account, a link to which is always available in the right rail under the label of "Long-form writings."

The first such piece is about the Medicare Access and CHIP Reauthorization Act (MACRA) and why MACRA, which was colloquially known as the "permanent doc fix," is going to be a huge issue in the 2020 election. In fact, some time next year, I expect the very serious flaws in this legislation to explode in the public consciousness and to become the next "crisis" in healthcare financing.

If you'd like to get ahead of the topic to prepare yourself, take a look at the linked piece. I'd be happy to continue the discussion of this topic in the comments on this post.

People Care about Their Cost for Medicine, Not Pricing

The Kaiser Family Foundation released a poll showing that most Americans of all political persuasions support requiring prices in prescription drug ads, as supported by President Trump.

Ed Silverman of Stat News wrote a story about this poll, including a few comments from me. Later, I mentioned on Twitter that there was at least one important point I didn't tell Ed.

The poll didn't ask people what price to include (WAC, AMP, NADAC, FUL, AAC, SWP, etc.), and that's not surprising, since most people don't realize that there are so many different prices for prescription drugs.

That's an important point. There are tons of prices for prescription drugs, and at the end of the day, none of them correlates with what consumers actually care about.

Consumers care about how much THEY will pay for their prescriptions, but there's no way to determine that for all consumers, so any price that is presented is AT BEST deeply misleading.

What actually determines the price paid by the consumer at the pharmacy counter is a combination of: 1) what insurance (if any) they have, 2) which pharmacy they're using, 3) where they are in terms of their personal/family deductible for the year (or progress toward the prescription drug donut hole for those with Part D coverage), and 4) whether the manufacturer has any sort of copay or patient assistance program.

The WAC for Drug A might be $100, but if my copay is $4, then that's what matters to me. And if Drug B has a WAC of $50, but my copay is $25 for Drug B, then I'm not going to prefer Drug B despite the lower WAC.

I didn't conduct the Kaiser survey, and it would be difficult to ask the right questions to get at this issue, but if the pollsters were to include questions about things such as which price matters to a consumer, or what consumers mean when they say they want the "price" included in the drug ads, I suspect that what they'll find is that when pollsters ask, "Do you want pricing in drug ads?" what consumers hear is, "Do you want the ad to include how much you'll have to pay out of pocket for the drug?"

And unfortunately (or fortunately), there's no way to do that. I don't mean it's very hard to do that. I mean it's impossible to do that. Because the factors (as discussed above) are deeply personal, there's no way a manufacturer can include that information in their ads.

As Peter Pitts noted in a recent column, one factor driving the recent emphasis on drug pricing is the transition to high-deductible plans. As Americans are being asked to shoulder more of the costs out of pocket, they're becoming more aware of the high cost of some prescription drugs.

A few years ago, I learned just how much variety there is among pharmacies even for generic drugs, when I was buying medicine for a family member who did not have health insurance. I called several different pharmacies because the price was solely coming out of my pocket, and I was shocked to learn that the price varied from more than $150 to $10 for a 30-day supply. Needless to say, I chose the pharmacy with the $10 prescription.

All of this is to say that in addition to the issues I've previously discussed on how unlikely it is for FDA to mandate the inclusion of drug pricing in ads, consumers really don't understand what is being proposed, and as a consequence, they're unlikely to be happy with anything that results.

As I said to Ed during our phone call discussing this in comments that wound up on the cutting room floor, this is a situation where consumers are angry at pharmaceutical companies and I suspect that a significant part of the bipartisan support for including pricing in ads is along the lines of, "if pharma companies are against it, then it must be a good idea."

Careers in Food & Drug Law

I started law school last year, enrolling in Drexel University's Thomas Kline School of Law's accelerated JD program. In the fall, I'll begin my final year.

Among other things, becoming a law student made me learn about the Food and Drug Law Institute's group for those new to food and drug law (NFDL). Although I've been involved with FDLI for more than a decade, I wasn't aware of this program, which has a variety of programs and opportunities for young lawyers and law students who are new to the food and drug bar.

In March, I organized an FDLI event at the Kline Trial Advocacy Institute in Philadelphia. This was the first NFDL event outside the DC area, and approximately 40 law students from area schools attended.

The current issue of FDLI's Update magazine has my write-up about the evening's event, including some of the insights from Gayle Lawson of the FDA, Paul Savidge of Spark Therapeutics, Yvonne McKenzie previously of Pepper Hamilton, Amy Rick of FDLI, and Marlene Shea of Johnson & Johnson.

If you know any law students considering a career in food and drug law, I hope you'll share the piece and let them know about the NFDL.

Drug Ads Won't Include Drug Pricing Anytime Soon

Updated

Earlier today, the President announced a series of measures intended to lower drug pricing. Most of the measures were expected, but one particular item caught my eye.

"FDA is going to get straight to work on having drug companies share their prices in direct-to-consumer ads," said Secretary Azar, according to this transcript of his prepared remarks. That piqued my interest because ad-promo is sort of important to me. I just spent two days training people on all of the FDA's ad-promo requirements. Do I have to revise all of my materials and send out corrections to the attendees?

This announcement was part of the American Patients First blueprint, so I went to take a look at the blueprint itself. And there it is on page 11.

Listed under the heading "Immediate Actions," "FDA evaluation of requiring manufacturers to include list prices in advertising."

And then again on page 25, "HHS may" (emphasis added)
"Call on the FDA to evaluate the inclusion of list prices in direct-to-consumer advertising."

That's a far cry from FDA beginning to require companies include drug pricing in their advertising.

I'm well acquainted with 21 CFR 202.1, and I can't figure out under what provision FDA could reasonably interpret companies to have an obligation to include list prices.

Even determining what that requirement is would take some time, since there's the list price for a single dose, the price for a standard course of treatment, the annual price for people who take the treatment, etc.

So, it will indeed take some "evaluation" from FDA to determine how to require such inclusion in advertising. That might be why the FDA commissioner's statement about today's plan neglected to mention this item.

And of course, there's a separate question of whether there's a legal basis for such a requirement.

Congress certainly could pass a law to require the inclusion of this information in advertising. Fairly recently, Congress required that print advertising include the "MedWatch" statement.

Such a new requirement would probably face court challenges, as many "compelled speech" provisions have been facing court challenges.

And as part of its deliberations, Congress would, I hope clarify things such as exactly what ads this requirement applied to.

Assuming Congress figured this out, the President signed the bill, FDA promulgated the relevant regulations, and everything successfully survived court challenges, there could at some point in President Trump's third term be a new requirement for prescription ads to include pricing information.

Why, though, would anyone want this? What exactly is the mechanism by which such a requirement would lower drug pricing?

I can think of two possibilities. First, shame. Perhaps, the idea is that pharmaceutical companies would be simply too embarrassed to include the price of very expensive drugs in their ads. Based on this idea, just exposing the prices to the light of day would itself result in the prices being lowered.

I find this idea implausible. Companies already make their prices public in various ways. It isn't unusual for companies to announce pricing in investor notices or announcements of drug approvals. That publicity hasn't resulted in any lowering of costs, and I see no reason why this would change things.

The second possibility is that consumers would demand lower-cost alternatives. I guess the idea is that a consumer who sees an ad for a potential cancer treatment with a list price of $100,000 would think, "Gee, I better look for a less expensive alternative treatment."

I don't know why a consumer would think that, and I also don't know why anyone would find it desirable to have consumers do so.

Would a consumer who definitely won't be paying the full list price really respond to seeing the list price by looking for a less expensive treatment? I doubt it.

But more importantly, I don't want consumers deciding against a course of treatment based on the list price. In FDA's 2017 guidance about presenting health care economic information to payors, FDA stated that sponsors should present this information to people with the skill to understand such information and quoted the House report that the legal provision permitting such communications were "not intended to permit manufacturers to provide such health care economic information to medical practitioners."

If FDA and Congress were concerned that physicians would not understand healthcare economic information, why would anyone think that mandating the presentation of incomplete HCEI to consumers is a good idea? Because remember that list price of treatment is only one factor in determining actual cost effectiveness of treatment.

TL/DR version: This is a bad idea that would at a minimum require new regulations to become an actual requirement. It probably requires a new law to authorize it. I fully expect that this proposal will generate a ton of headlines and chatter for the next few days, and then be quietly ignored by people who actually care about controlling the cost of medications.

Update (May 27, 2018): A group of Senators sent a letter to several major pharmaceutical companies urging them to voluntarily include drug prices in their ads. It's unclear to me whether this letter makes it more or less likely that the Senate will take up and pass legislation to add this requirement to prescription medicine ads.

FDA Product Name Guidance Finalized

Last week, the FDA published a final version of the Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements.

FDA has been remarkably active on this topic, as this is now the third update to the guidance in the past five years. People who have been following this guidance will be pleased to hear that there's little new. Though there are many changes, there are no substantial changes from the 2013 version. The most significant development in the new guidance is the provision of examples demonstrating FDA's principles about prominence of the product name.

If you'd like a quick overview of the guidance, I suggest this one from Intouch Solutions.

WTA?

Disclosure: I sit on the Google Health Advisory Board, and Google has been a client of PhillyCooke Consulting. Nothing in this post has been shown to Google or received the endorsement or approval of anyone at Google. I have discussed the topic of this post with Google employees.

"Why this ad?" (WTA) functionality has suddenly become hot news in the pharmaceutical industry. For those of you who have not noticed it previously, or heard the hubbub, here's the deal.

Google takes transparency quite seriously, and given the privacy concerns everyone has about trusting any company with as much information as Google maintains on people, it's understandable why.

As part of its transparency efforts, Google added some new functionality to its search engine marketing (SEM) results a few years ago. Users are able to learn why a particular ad is being presented to them.

In practice what users see is a symbol (either an encircled letter "i" or a green triangle) next to a promoted message.

The red box surrounds the symbol in mobile and desktop search results that
enable the user to learn more about the ad targeting.

Users who click on the symbol see a question appear, "Why this ad?"

These images show the "Why this ad?" popup that users see after clicking on the symbol.

Clicking on the question prompts a further box to appear with information about why that particular ad was displayed to the user.

There are differences between the functionality in a desktop/laptop and a mobile environment. For example, in the mobile environment, the shadow box effect obscures and separates the underlying ad from the information supplied by Google more than the overlaid box alone that is seen on a laptop.

Both mobile and desktop ads display the root URL of the destination from the ad at the top of the box, and both allow signed-in users to opt out of seeing ads from that URL via a slider at the bottom of the box, which again displays that root URL of the destination webpage.

The reasons provided for what the ad is based on will vary depending on what caused the ad to appear. The factors listed in SEM ads will always include the search terms and might also include factors such as location (if the user permits Google to access that information) or that the user has previously visited the site.

The WTA information and functionality is not advertising content. No advertiser is permitted to alter this content or has any control over it. Advertisers indirectly influence it via the parameters that they set for determining when their ads appear. For example, if an advertiser targets only users who have previously visited their website, then that factor might appear, whereas if the targeting is solely based on the search terms, then it would be less likely to appear.

Some people have recently learned about this functionality and raised questions about whether it poses a potential risk for violating the Food and Drug Administration's (FDA) advertising regulations.

The scenario these people envision is that a company is using a redirecting ad, which by definition doesn't include the brand name in the ad itself but instead redirects users to a Brand.com website. If a user sees such an ad and clicks on the WTA symbol, and then clicks a second time on the "Why this ad?" popup, the user will see the brand name appearing because the brand name is most often the root URL of the home page for the destination of the redirecting ad.

The FDA has made clear via previous enforcement actions (such as many of the infamous 14 search letters from 2009) that merely using the brand name in a URL is considered by the FDA to be a mention of the drug for the purposes of advertising the product, and carries with it all of the requirements associated with any other product name mention.

Depending on the type of ad, the requirements might include only the inclusion of the brand and generic names and the relative sizing of the two, or they could be as extensive as the inclusion of the complete indication statement, dosage form, etc., associated with a full product promotion.

Let's first address the idea that a company could be out of compliance because the brand name of its product appeared without the generic name. The brand name is appearing in a location over which the company has no control. As mentioned earlier, the popup box is not itself an advertising unit. Companies cannot ask Google to change the information that appears in the box, and they have no control over it. There is some indirect influence, but this is definitely not a company-owned or company-controlled communication. Consequently, it would seem that this appearance of the brand name would be analogous to a newspaper using the brand name, and newspapers frequently use the brand name of drugs without including the generic name. 

FDA would never take enforcement action against a company for that type of third-party action, and it is hard to imagine that they would do so here.

Then there's a second issue. Depending on whether a user is accessing the ad via a mobile device or a desktop computer, the user might be able to see the underlying ad at the same time as the overlay. It is certainly possible that this could mean that a user sees both the brand name and some of the underlying redirecting ad, which was so carefully designed by the company to avoid including the brand name. In some cases, there is information in the redirecting ad that would be considered by the FDA to describe the product's use. And in that same set of infamous letters from 2009, FDA made very clear that including some description of a product's use with the brand name carries with it the full requirements associated with a complete production promotion (indication statement, etc.).

Does that pose a risk of FDA enforcement? 

For FDA to take an enforcement action in this instance, FDA would have to hold a company accountable for a message over which it has complete control (the underlying redirecting ad) when that message is combined with a separate message over which the company has no control.

It seems hard to believe the FDA would do something like that.

I admit that I would be happier if the WTA overlay box behaved the same way on a desktop as it does on a mobile device, with the shadow box effect that obscures the underlying ad and that also makes the separation between the two communications more clear.

But even without this change being implemented, I see an extremely low risk that FDA would take an enforcement action for an advertising publisher creating a tool that reveals more information than an advertiser wanted included in their ad.

While Google is determining what (if any) changes to make to its WTA functionality in light of the latest stir, I would submit for all of the reasons above that this poses a low risk of enforcement.

FDA's One-click Study

At the beginning of November, FDA announced its intention to conduct a study looking at the so-called "one-click rule." As readers of this blog know, I've termed this, "The 'Rule' That Isn't."

The basic idea behind any version of the one-click rule is that companies can meet their fair balance requirement (21 CFR 202.1(e)(5)(ii)) by including a hyperlink to the risk information, rather than by providing the risk information itself in the original communication. As I've written about previously, this idea has had significant allure for marketers of prescription products but there has never been any indication from the FDA that it was open to it...until now.

I have been working with a few different clients preparing comments on the study proposal outlined by the FDA. Those will be posted to the docket and available for public view at a later date.

In this post, I wanted to take a step back and look at what this study means (and what it doesn't mean) for the immediate and future use of space-limited contexts by prescription product manufacturers and FDA guidance about this issue.

In 1998, FDA took its first enforcement action for Internet marketing. At the time, the FDA noted that "the link to the full prescribing information alone is insufficient to meet the requirements...that advertisements contain fair balance."

This began an 18-year history of the FDA making clear that it did not acknowledge a one-click "rule." This position was further solidified via FDA's 2014 guidance on space-limited contexts (the so-called "Twitter Guidance") that directly addressed the use of Twitter and search engine marketing formats that explicitly limit the number of characters. In that guidance, FDA asserted, "Regardless of character space constraints that may be present on certain Internet/social media platforms, if a firm chooses to make a product benefit claim, the firm should also incorporate risk information within the same character-space-limited communication." This is as explicit a rejection of any version of a one-click rule as FDA could possibly have made.

Just one sentence earlier in the guidance, FDA further asserted that, "If an accurate and balanced presentation of both risks and benefits of a specific product is not possible within the constraints of the platform, then the firm should reconsider using that platform for the intended promotional message (other than for permitted reminder promotion)."

Combined, these two statements established a framework that FDA was explicitly acknowledging could not be used by some manufacturers of prescription products for making claims about the benefits of their products. The consequences of this framework is that in certain contexts only products not subject to FDA's fair balance requirement would be able to provide benefit information about their products.

Of course, "benefit" information includes any suggestion of the product's indication. In practice, this means that prescription products manufacturers are frequently prevented from letting people know that their product(s) are possible treatment options for them; and that FDA's official position, as expressed in the 2014 guidance, is that this is fine.

Many people objected to this aspect of the draft guidance (see, for example, the comments from PhRMA), and that resulted in a brief movement to include a version of the one-click rule in the 21st Century Cures Act.

In that context, FDA's openness to studying these issues is a major step forward. Rather than simply assuming without any evidence that the public is harmed by companies following some version of a one-click rule, FDA is actually studying the issue.

This positive development is balanced, however, with the study design itself. In the proposed study, FDA is comparing a format that makes use of a one-click rule with a format that follows the recommendations from the 2014 guidance. One problem with this study design is that it is comparing a format that the FDA has acknowledged is not available to all product manufacturers because of the nature of their specific indications and risks. Indeed, I'm not aware of a single company that has attempted to use the format FDA demonstrated in that guidance for Google search or a Twitter ad.*

In addition, although FDA's willingness to study this topic is refreshing, the study announcement coming late in 2016 would seem to indicate that the status quo will remain for several years. It has been more than a year since FDA has released any new or updated guidance related to advertising and promotion (the last one was a minor revision in August of 2015), and the existing FDA guidance on space-constrained contexts has some glaring issues, independent of the position on one-click.

Taking a generous view of FDA's speed in fielding this research, it would be difficult to imagine that the final study results would be available before the end of 2017. FDA absolutely takes the work of its research team into account in developing guidance, including the ad-promo research. That probably means that the earliest we would see any update to the 2014 guidance would be 2018.

That's four years after FDA released the draft guidance and nine years after the 2009 hearings. FDA can't be expected to provide guidance that keeps up with the pace of technological change. Indeed, I think that's a virtue rather than a drawback to FDA's approach. It's better to have guidance that lags slightly behind innovation rather than wasting time developing guidance on topics that prove to be mere flashes in the pan. Consider the wasted effort if FDA had developed a guidance dedicated to Sidewiki after its 2009 hearings.

This, however, is a very different situation. FDA's enforcement activity related to its rejection of any version of the one-click rule has spanned nearly 20 years. Throughout that time, marketers of prescription products who want to inform the public about how they can help have been hindered in the ability to make that information available in the platforms that people are showing they prefer. And only now is FDA announcing its intention to see whether that position has any basis in actual experience. 

* If anyone is aware of such an ad, please share it in the comments or via the contact form in the right rail.

Google's Latest Ad Format Update

Google recently announced a change to its standard ad unit. This marks the third significant change affecting marketers of prescription products in the past year who are using Google.

At this point, I'm definitely seeing the need to revisit my article on using Google to market prescription products and even the presentation from last fall's FDLI Advertising and Promotion conference is now out of date. Over the next few months, I will be providing more on that.

In the meantime, here's the skinny on the update.

Google is fully embracing a mobile-first world view and is expanding the character count limitations for text ads.

The chart below (lifted from Google's public blog post) shows the breakdown between the current and the new formats.

For the ad copy, an additional 35 characters will be available for the headline, and an additional 10 characters will be available for the description. As pointed out by Convergence Point Media, in practice, this might expand the total characters available in a description even more than 10 characters because the description will no longer be treated as two separate 35-characters fields. That might mean that marketers are able to avoid the waste that sometimes is entailed in the current two-line description.

The primary benefit for marketers of prescription products is that it will be easier to meet their requirements for promoting drugs without a black box via a reminder ad and for black box drugs to fit all of the required elements for a reminder-like ad. This is most particularly relevant to fixed dose combination products. When the product being promoted has four or five active ingredients, it can very quickly be difficult to fix everything into the current character count limitations. Yet, failure to use the full established name remains on FDA's radar both in guidance and enforcement as a key regulatory requirement.

In addition to this expansion of the character counts, the display URL will be treated differently. Currently, marketers are able to manually enter a distinct display URL for their ads. In the new ad format, the display URL will be "automatically extracted" from the destination URL, with some (but only minimal) ability to customize the display URL seen by users.

This change has far greater implications for prescription product marketers, as it is precisely the ability to have a difference between the destination and the display URL that enables marketers to make use of redirecting ads.

If the ads automatically extract the base URL from the destination URL, then the mismatch between display and destination URL that is essential to redirecting ads will no longer be possible. This would significantly limit prescription product marketers' options. 

The biggest concern is for smaller, less well known brands. For those brands a reminder ad is not viable because very few people are already aware of their brand name; hence a reminder ad that doesn't describe the product's use has no value. But if the redirecting ads are eliminated, then such lesser known brands would have no way of attracting people who are looking for treatments. By assumption, these brands are not as well known which also means that their organic listings are not likely to be very high, so this would have a deeply chilling effect on the information available to people using Google. In essence, Google paid search would no longer be a viable means for building brands, but only for maintaining brands built on other platforms.

At the moment, Google has not provided any information about when this update will move beyond its initial testing to be available for everyone, or when it will be mandatory that ads adopt this new format. For now, this is simply something that marketers and regulatory professionals will need to stay abreast of.

It is also important to note that Google isn't synonymous with search, though it is the largest platform by a significant margin. Yahoo! and Bing remain very large players in this arena, and there's no reason to assume that Yahoo! and Bing will automatically adopt Google's changes. As a practical matter, this will probably mean having multiple sets of paid search campaigns going through the review and approval process.