On September 29th, the New York Times reported:
Former Drug Executive Convicted of Wire Fraud
In a verdict that could strike fear into pharmaceutical industry executive suites, the former head of a drug company was convicted of wire fraud Tuesday for issuing what federal prosecutors called a misleading press release that contributed to off-label sales of his company’s drug.
(Full story here: http://www.nytimes.com/2009/09/30/business/30drug.html)
There are rules that need to be followed and there are consequences for those who play fast and loose with them.
Except, it seems, if you are the rule-maker.
Here’s an FDA announcement that appeared Friday (October 16th):
FDA Approves New Indication for Gardasil to Prevent Genital Warts in Men and Boys
The U.S. Food and Drug Administration today approved use of the vaccine Gardasil for the prevention of genital warts (condyloma acuminata) due to human papillomavirus (HPV) types 6 and 11 in boys and men, ages 9 through 26.
(Full FDA release here: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm187003.htm)
Wonderful public health news and certainly worth promoting. And kudos to the FDA for using a regulatory action to discuss an important public health issue.
The interesting issue is how the release ends:
“Gardasil product information: www.fda.gov/cber/products/gardasil.htm”
That link doesn’t bring you directly to the package insert, but rather to a page where you can access the package insert.
Would a pharmaceutical company be permitted to forward such an FDA announcement along to others without more detailed risk information? What about posting the FDA announcement to a commercial website? What about handing it out to physicians?
In 2002, when I was the FDA's associate commissioner for external relations, Dr. Janet Woodcock (then, as now, CDER Director) came in to my office and she was not smiling. She waved a draft of a new drug approval press release at me and asked, "How is anybody supposed to understand this? It's written for scientists!"
I felt her pain. My answer to Dr. Woodcock was that the press office had written a much more consumer-friendly document, but that the release had, quite literally, been doctored when sent to the Center for Drug Evaluation and Research for review. Rather than focusing on the important public health message intrinsic in the new drug approval, the career science staff insisted on putting in more science. "Well," she said, "that's not going to happen anymore." And that was the beginning of a beautiful relationship.
What that story demonstrates—and why I never tire of retelling it—is that communications at the FDA is a perfect example of the maxim, "It's not what we say that matters—it's what our target audience remembers." All the science in the world—precise and important as it may be—is not going to help the average consumer understand why a new drug is important, why it was approved, or even what it does.
So, this isn’t about FDA needing to add more risk information – their release speaks in plain English to the general population. Well done. The question is, shouldn’t pharmaceutical companies be allowed to do the same? Isn’t a clear message in the best interests of the public health? What’s required is a more titrated approach to communications that -- like DTC TV guidance -- provides a clear pathway for achieving compliance while respecting the inherent space/time limitations of any given medium.
