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!
Showing posts with label DIA. Show all posts
Showing posts with label DIA. Show all posts
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:
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
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.
The Value of Virtual Communities
At last week's Drug Information Association's (DIA) Marketing Pharmaceuticals* conference, Kim Belsky of OneSource Regulatory spoke about the DIA Ad-promo group. Kim and Tracy Rockney, who founded OneSource, are co-chairs for the group.
This is a virtual community open to DIA members, and there are monthly sessions with set topics. Today's call is slated for noon, and the announced topic is the 2015 enforcement activity from OPDP. I suspect, however, that the agenda might be hijacked by the settlement between Amarin and FDA that was announced last night.
I'm still reading up on the settlement and expect to add to my previous discussion of the issues raised in this legal challenge.
I wanted though to note how nice it is to be able to hop on a call while this topic is fresh and hear what others are saying. There's a vibrant community of ad-promo regulatory professionals, but we tend to be dispersed around the country, and any given company will rarely have more than 10 of us. So, being able to jump on a call and hear the perspective of others is fantastic.
If you aren't already a member of the DIA ad-promo group, I hope you'll join. Just hop over to the DIA communities page and select the link for the Regulatory Affairs A&P group.
* BTW, I hope to post a recap of the conference in the next few days. You can see my live Tweets on Twitter using the hashtag #MarketingPharma16
This is a virtual community open to DIA members, and there are monthly sessions with set topics. Today's call is slated for noon, and the announced topic is the 2015 enforcement activity from OPDP. I suspect, however, that the agenda might be hijacked by the settlement between Amarin and FDA that was announced last night.
I'm still reading up on the settlement and expect to add to my previous discussion of the issues raised in this legal challenge.
I wanted though to note how nice it is to be able to hop on a call while this topic is fresh and hear what others are saying. There's a vibrant community of ad-promo regulatory professionals, but we tend to be dispersed around the country, and any given company will rarely have more than 10 of us. So, being able to jump on a call and hear the perspective of others is fantastic.
If you aren't already a member of the DIA ad-promo group, I hope you'll join. Just hop over to the DIA communities page and select the link for the Regulatory Affairs A&P group.
* BTW, I hope to post a recap of the conference in the next few days. You can see my live Tweets on Twitter using the hashtag #MarketingPharma16
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.
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:
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:
- Mobile is no longer fringe for people consuming health information
- Device proliferation and interaction is real. Your content is just one node in a larger ecosystem.
- Phone/phablets keep getting bigger (which fuels further consumption and makes supplying all of your information easier)
- However, although the phone footprint is bigger the proliferation also means people are interacting using other interfaces, such as voice recognition and spoken responses.
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 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.
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 panel I'm leading will feature participation by AstraZeneca, J&J, Twitter, and YouTube. Here's the description from the conference webpage: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
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.
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