FDA Transparency Initiative: Meeting Held to Discuss Opportunities for FDA to Foster Innovation
On August 11, the White House Office of Science, Technology, and Policy (OSTP) hosted a meeting with FDA Principal Deputy Commissioner, Dr. Joshua Sharfstein, United States Chief Technology Officer, Aneesh Chopra, members of the White House Open Government Initiative, and the health care investor community at the White House to discuss ways FDA can make useful and understandable information available about the product approval process and how transparency at FDA can foster medical product innovation. Participants included individuals who invest in small, mid-size, and large companies that develop a range of products regulated by FDA. During the conversation, participants provided feedback to FDA and OSTP in three main areas: (1) how FDA can better explain its processes and operations, (2) what information would be helpful for FDA to provide to sponsors that submit product applications to the agency, and (3) how transparent processes at FDA can foster product development and innovation.
The comments shared during this meeting will be used to inform FDA's work of developing the recommendations about how to improve transparency and open government at the agency. Those recommendations will be delivered to Dr. Margaret Hamburg, FDA Commissioner, in approximately five months.
Afia Asamoah, FDA Transparency Initiative Coordinator
Is there a transcript or recording? It is desirable for a meeting on transparency to be transparent.
Why was industry the only group really represented in this meeting? What about civil society, patient groups, and the public at large? I strongly doubt that they have nothing to say on these issues.
I would have attended this meeting had it been conducted (ironically) in a transparent and accessible way.
Although this meeting was called a “meeting with investors”, a few of the participants are not investors. Rather, they represent biotech industry itself. For example,
Michael Doherty is a Global Head, Pharma Regulatory Affairs at Hoffman-la Roche (not Genentech). According to his public Linked-in profile, he resides in Switzerland.
Barry Eisenstein is a biotech company Cubist Senior Vice President for Scientific Affairs.
John Griffin is a Chief Scientific Officer and Principal Investigator of the Project at a biotech Numerate.
It is surprising to see these people characterized as investors.
So it’s now one year since the new administration took over the FDA and they have finally started something that looks like transparency (though I’ll reserve judgment, thank you). And they’re crowing about this?!? Gimme a break! I have followed the FDA for 20 years, and — as a consumer advocate — I’d say this represents some of the “worst of times.” Was the Bush FDA worse? Sure. How much worse? At this point I’d say Obama’s FDA is giving them a real run for the money.
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Outstanding efforts in the right direction. True change takes time and trust issues still must be resolved, but this appears to be moving in the overall right direction to me.
Outstanding efforts in the right direction. True change takes time and trust issues still must be resolved, but this appears to be moving in the overall right direction to me.
This is definitely the right move. Increase the transparency so we can know what they are doing behind those “BIG” meetings.
- Oleg Mart
I also agree that this was certainly the right move, thanks for all of your hard work and effort put in!