On Thursday at FDA's Part 15 Meeting on Social Media and Medical Product Promotion on the Internet – PhRMA offered up one solution that became a focus of commentary for many. The idea, put forth in remarks delivered by PhRMA's Assistant General Counsel Jeffrey Francer, would put FDA in the driver's seat to be the arbiter of what is good Internet content that meets regulatory guidelines and what is bad. Some people embraced the idea right away, others not so much. I fall into the latter category because I think the proposal ignores the fact that the FDA has done such a stunningly poor job in regulating emerging media, that they would rather issue 14 Notice of Violation letters rather than to adapt existing regulatory standards to new media and enunciate sound policy. With that kind of poor judgement at the steering wheel, I'm not sure this proposal would solve the bigger problem – FDA's lack of process for evaluating and regulating new media. That is more of a problem than any content issue.
But read their proposal and watch the video and decide for yourself. Sorry for the substantial background noise, but FDA did not provide a media room at the venue, nor any accomodation for media (though they did provide a special room for seating for government officials – like they couldn't sit with us rabble):
About the AuthorMy name is Mark Senak. I’m a lawyer and I work at the international communications firm FleishmanHillard in New York. For the past several years, I have been consulting with pharmaceutical and biologic companies that are engaged in the process of bringing new drugs to market. I have also worked extensively with an array of medical societies and patient organizations providing strategic communications counsel and media training.
My ProfileI am an authority on regulatory aspects of communications and medical products, with particular emphasis on pre-approval communications; strategist to help pharma and biotech companies prepare best case for advisory committee approval; and counselor in issues and crisis management. I am a frequent speaker on various aspects of same - drug development, promotion, reimbursement and new media in a highly regulated environment. Author of books, newspaper and magazine pieces related to drug marketing and promotion as well as HIV specialty pieces. And of course... blogger!
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Eye on FDA is published by Mark Senak of FleishmanHillard’s New York office. The thoughts and ideas in this blog and postings are strictly my own and are not screened by my employer. Everything posted on this blog is my personal opinion and does not necessarily represent the views of FleishmanHillard or its clients.
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I reject this proposal because it would be relatively unworkable.
If manufacturers want FDA to “endorse” their sites (presumably, by reviewing their content) and provide some sort of symbol approving the veracity of the information; they’re going to have to submit it to FDA before going live. In some cases, industry already does this. In others, industry has checked with DDMAC informally before rolling out a campaign. Only in very narrow cases do they need FDA approval before they can market.
Under this proposal, industry would need to wait for FDA to approve the content before they could go live using the symbol. Do you think companies would be willing to wait for FDA? They think product review times are too long already.
Also, once a site receives such symbol, how would FDA insure the content wasn’t changed to the point where it didn’t meet muster?
BTW, I was sitting in the “special” room. It was too far away to read the presented slides. The “rabble” got the best seats.