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FDA: A Hit and A Miss

FDA Matters has watched FDA handle the Avandia decision differently from any prior controversy. I like the new approach. In the same week, FDA provided a status report on its long-overdue social media and Internet communications policy. Because the agency’s efforts have been glacial, the prospect of useful guidance is dim. I think this is a serious problem.

FDA’s Handling of the Avandia Situation. A HIT

FDA Matters was heartened by the agency’s deft handling of the Avandia situation. Previous columns have explored how hard it is to achieve cultural change at FDA and why it requires the Commissioner and the agency’s senior leadership to be role models.

With the Avandia decision, the agency has demonstrated progress toward two related changes: improved transparency and allowing internal dissent to become part of the public dialog.

Transparency is not part of the FDA’s DNA. Despite this, the agency has responded to the President’s government-wide transparency initiative with a serious effort. In doing so, it has struggled–mostly against itself–in making its processes and decisions more readily available within and outside FDA.

The Avandia advisory committee meeting and the FDA website were remarkably transparent about the controversy and the details. To clarify the ultimate decision, Drs. Woodcock, Sharfstein and Hamburg authored a 1500-word explanation, which appeared in the New England Journal of Medicine.

Embracing dissent has always been hard for FDA. Its customary position of “speaking with one voice” is not an accurate reflection of what happens when well-trained, analytically-oriented people gather to make a decision. With Avandia, Commissioner Hamburg has conspicuously incorporated dissent into the process.

Cultural change at FDA is difficult and always takes time. The Avandia decision is a significant step forward, demonstrating that agency leadership is committed to changes and understands that it must serve as role models.

FDA’s Handling of Policy Development for New Media: A MISS

As a rule, businesses do not like additional regulation. There are two exceptions: where it levels the playing field with competition and when it creates certainty on how companies should conduct their activities. These are the exact reasons why FDA-regulated medical products companies have repeatedly asked FDA to issue policy guidance on Internet activities.

As best I can tell, FDA’s first hearing, “FDA and the Internet: Advertising and Promotion of Medical Products” occurred on October 16 and 17, 1996. http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm175775.htm. That’s 14 years ago!

While FDA has studiously ignored the opportunity to provide policy guidance and regulation, the Internet has become a primary means of written and visual communication. Search engines control an ever expanding numbers of online interactions. Social media has flourished.

Apart from agency action against some companies for activities that many consider ethical and reasonable and a two-day hearing in November 2009…not much progress seems to have occurred toward providing more direction to industry. At a Food and Drug Law Institute meeting last week, the agency suggested a draft guidance–the first of many–may be issued later this year. Even assuming this occurs on schedule, it will take at least a year to finalize.

I suggested last year that FDA was mistaken to see Internet policy development as overwhelming. Rather, it is a number of smaller issues that can be addressed separately without a broad Internet policy. An additional advantage of this approach: it recognizes that any Internet policy guidance will be outdated before FDA can ever issue it.

After 14 years, this calls for the intervention of agency leadership, not continued delays.

Steven

Gardner Harris of the New York Times also observed the changes at FDA that have occurred as part of the Avandia decision. His column is at: http://www.nytimes.com/2010/09/25/health/policy/25avandia.html?_r=1&emc=eta1.

For those interested in more coverage of FDA and social media, I recommend Mark Senak’s Eye on FDA column at www.eyeoffda.com.

Is the New FDA Different than the Old FDA?

June 13th, 2010

Two weeks ago, FDA Matters explored Dr. Hamburg’s legacy, focusing on advocacy for resources, prioritizing regulatory science and upgrading enforcement. These will be accomplished before she leaves office. But is she making similar progress in creating “a new FDA, including changes in agency culture?” Read the rest of this entry »

Dissent and Efficiency: Difficult Trade-offs for FDA
May 9th, 2010

FDA has a reputation for being tough on dissent, whether it comes from employees or regulated companies. Whatever the truth has been in the past, FDA is trying to develop an institutional cultural that welcomes and accepts dissent from employees, industry and other stakeholders. It is difficult, even messy, to do this. Read the rest of this entry »

Internet Communications: FDA Needs to Divide the Issues to Conquer the Problem
December 2nd, 2009

Creating an Internet communications policy for regulated medical product companies is so daunting that FDA has largely ignored the responsibility. New policy will not be announced anytime soon. FDA needs a different approach. This is not a matter of a large, complicated problem with many facets. Rather, it is a number of smaller problems that can be addressed separately. Read the rest of this entry »

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