Science and Politics at the FDA - Pharmaceutical Executive


Science and Politics at the FDA

Pharmaceutical Executive

PE: You characterize the pharma industry as historically intimidated by the FDA, for example adopting the agency's increasingly stringent preapproval rules for how drugs are tested. If that is true, why is there such a widespread perception that the FDA is in the pocket of pharma?

DC: Most of the book is about the era from the 1930s to the early 1990s, when intimidation held true. Yet it is fair to say that things have changed. Perceptions matter, and when the agency reversed its longstanding position on pre-emption, it made the agency look inconsistent and obsequious.

User fees have added to the perception problem; it's not just me saying that, but [former general counsel at the FDA] Peter Barton Hutt, too.

The solution is not clear. Marcia Angell and others would have us do away with the fees altogether. I tend to favor Rep. Maurice Hinchey's (D-NY) solution, which is to keep the revenue, be honest and call it a tax, and sever the contractual tie between the taxes and agency performance.

PE: You write that FDA officials view some pharma companies more favorably than others. For example, Merck was seen as having considerable scientific integrity, and this may have swayed the FDA officials to approve Vioxx despite early safety signals. What determines a pharma company's cachet at the FDA?

DC: Scientific integrity is often witnessed through full disclosure—the capacity to admit weaknesses in one's own arguments or data. Assuming that the problems identified by FDA drug reviewer Dr. Thomas Marciniak in the Avandia case [reporting that at least a dozen patients on the drug in a major clinical trial had suffered serious heart problems but were not counted by GSK as adverse events] could have been identified by GSK officials beforehand, the company would have fared far better if it had admitted to these problems and focused on showing alternative interpretations of its results.

When you present a study as fully robust, it's easy for someone to cherry-pick the problems. Every study, and every drug, will have its "soft underbelly," so why not be rigorous about disclosing it? That kind of circumspection could serve the pharmaceutical industry well in its dealings with the FDA, the public, and the various scientific and medical professions.

PE: The reputation of the FDA has been tarnished over the past decade. In your analysis, this decline in trust coincides with the ascendancy in national politics of an antiregulatory ideology. This culminated during George W. Bush's administration with the appointment of FDA officials to carry out that agenda. What effect did this have on the career staff at the FDA?

DC: It had several effects. First, a lot of very talented people left the agency, and that damage will take a long time to repair. Second, a number of the people who remained began to adapt in different ways to the new reality. Some waited it out, others changed their minds. A large number of people were demoralized. The evisceration of regulatory capacity under the Bush administration is an inescapably sad tale.

PE: President Obama's top FDA appointees, Margaret Hamburg and Josh Sharfstein, came to the agency with distinguished records as public health officials and as previous heads of big city health departments. After their first 18 months in office, both have remarked at how long it takes for even small changes to work their way through the system. Is this just typical bureaucratic pushback or is some other kind of resistance at work?

DC: What may seem like bureaucratic pushback or intransigence is often attributable to the rule of law. Many of the FDA officials I've met are nervous about their obligations and limits under the law. In a constitutional system like ours, it can be a good thing when change comes slowly to administrative and regulatory agencies. Ultimately, governance of science or industry has to be consistent with the public good as encoded in law and regulation. It's a point that often gets ignored in the debates.

PE: After watching Commissioner Hamburg at the helm for 18 months, what kind of a job do you think she is doing?

DC: I'm impressed with her. One thing the commissioner has to do is to make good appointments and to communicate credibly. I think most would agree that Hamburg does both. Unlike the commissioners under George W. Bush, she understands that the FDA's credibility has been tarnished, so she is not overstating the agency's case on scientific or policy matters.

In addition, Dr. Hamburg and Dr. Sharfstein are pursuing a much-needed transparency initiative. With transparency, there are risks. As Hamburg's unprecedented decision to post on the FDA's website the conflicting memos of various FDA officials about what to do in the Avandia decision shows, by not presenting a united front to the public and the scientific community, people will perhaps begin to view the FDA as characterized by massive infighting. That said, in an age when anyone can tweet, blog, or talk to a reporter, I think she understands that there is a greater risk from trying to present a united front when there isn't one.


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