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Spring Brings Hope–Even about Transparency and Accountability in Government

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There is some good, albeit modest, news about the Food and Drug Administration and the way the agency addresses conflicts of interest on FDA advisory panels that consider the safety and efficacy of drugs and medical devices. We’ve wanted the agency to be more transparent, and to do more to reduce the number of conflicted experts who serve. We were distressed about conflicts that have affected votes when conflicted experts made it on to FDA panels without the agency’s acknowledging their financial ties to the companies that would benefit from the panel’s recommendations.

But lately we’ve seen some signs of hope at the FDA, some indications that policies are improving.

Spotlighting the advisory panels

On the transparency front, the news is good and straightforward. For years,  UCS, along with members of the Patient, Consumer and Public Health Coalition, had urged that FDA advisory panel meetings be webcast so that more Americans could understand the crucial recommendations these panels make and how they reach the conclusions they arrive at about the efficacy and safety or new drugs and devices.

The agency has begun to do just that. However, the move to webcasting is not perfect. If an advisory panel meets at a location outside FDA headquarters, it won’t be webcast. And the agency warns that sometimes the broadcast doesn’t work properly. But after years of making the case for webcasts, the fact that the FDA is starting on this road is heartening. This means that scientists, clinicians and interested activists can listen to an advisory panel meeting, view the evidence presented and the deliberations, and keep an eye on how well the agency protects public health and safety.

To a certain extent, some of the changes will lead to greater accountability at the FDA.

To a certain extent, some of the changes will lead to greater accountability at the FDA.

FDA also is taking some positive steps when it comes to addressing the problem of conflict of interest on its advisory panels. The fact that it’s made a few promising moves is surprising, given the actions of Congress two years ago.

In 2012, Congress approved a law that sent a strong signal to the FDA that conflicts of interest weren’t that important. Congress undid a requirement it had approved in 2007 that required the agency to gradually reduce the number of conflicted experts who served on advisory panels. Although the rollback was modest—25 percent over five years—it was enough to rally the opposition of pharmaceutical interests. These interests pushed very hard for the 2012 law, which eliminated the reduction requirement.

But to its credit, the FDA appears to continue to care about conflicts of interest. Just last month, the agency quietly released a final guidance document explaining how the agency intended to disclose information about financial ties to drug and device makers its employees or members of its advisory panels may have that could cause a conflict of interest.

Federal law requires that when an expert on a federal advisory panel has a significant financial tie to a company that will be affected by the panel’s recommendation, the expert can’t participate or must receive a waiver from the agency. The waiver is given if the agency feels the benefit of the expertise outweighs the “potential for a conflict of interest.”

The FDA’s guidance makes clear that if a conflict is discovered, the agency will get pretty specific when it issues a waiver, which must be publicly disclosed. In the past, when waivers were granted, the reason for granting a waiver was pretty vague. But the FDA is telling its advisory panel members that it intends to give pretty detailed information in the waivers it issues. The waiver will name the expert receiving the waiver and explain the nature of the conflict. FDA states that it will disclose “the type, nature and magnitude of any waived financial interests.”

In addition, a panelist has to understand the FDA’s disclosure policies and agree to them before accepting a position on an advisory panel. And the template the FDA has developed for reporting conflicts is pretty specific. Conflicts would cover a panelist’s investments or employment or work as a consultant or advisor, the holder of a patent, or work as an expert witness. Does the panelist work for someone with a relevant financial interest or have a business partner with ties to that interest? Is the panelist discussing a job with an affected interest? Does the panelist’s immediate family have such financial ties?

Because panelists have to sign a form agreeing to this public disclosure before accepting a slot on an advisory committee, they will be more focused on the longstanding requirement in federal law that they report conflicts. The FDA is not breaking new ground, but it is helping to reinforce the notion that conflicts matter.

While a good first step, the FDA needs to continue to ensure that Americans are safe from approved drugs and devices. This includes tackling conflict of interest in advisory panels head on.

While a good first step, the FDA needs to continue to ensure that Americans are safe from approved drugs and devices. This includes tackling conflict of interest in advisory panels head on.

The bigger picture

Of course, this doesn’t address the other big problems with FDA and advisory panels. The agency often has failed to find conflicts, or has decided that the conflicts were not serious enough to merit a waiver. Inadequate vetting or treating conflicts too lightly has sometimes called into question FDA advisory panel recommendations.

When they met to consider the controversial contraceptive drug, Yaz, for example, the advisory panel voted that the drug’s benefits outweighed its risks. But at least four members of the panel had substantial financial ties to its maker, Bayer. The panel made that decision despite reports of the increased risk of blood clots in those who took the contraceptive.  (The FDA in 2012 beefed up warning label requirements for the contraceptive.)

While the guidance doesn’t address this problem head-on, it opens the door for the public to help uncover and police such conflicts.

Before a panel meets, FDA now will publicly post a roster of all panel members expected to attend a meeting, along with briefing materials.  This advance “heads up” will make it easier for activists to scan the list of panelists and to identify experts with conflicts.  Once notified, the FDA will be under pressure to either issue a waiver to the conflicted expert, or ask the expert not to participate.

Change is never easy, particularly in this political environment.  When an agency makes some changes for the better, we should take notice.

Posted in: Science and Democracy, Scientific Integrity Tags: , , , ,

About the author: Celia Wexler is a senior Washington representative for the Scientific Integrity Initiative at UCS. A former award-winning journalist, Wexler is the author of Out of the News: Former Journalists Discuss a Profession in Crisis, published in 2012 by McFarland. At UCS, Wexler’s issue portfolio includes food and drug safety, protections for scientist whistleblowers, and government transparency and accountability. See Celia's full bio.

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