Life Science Compliance Update

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May 23, 2011

FDA Conflict of Interest Rules Means Fewer Experts on Advisory Panels

FDA Advisory Committee 
Forty-nine committees, with more than 600 members, advise the Food and Drug Administration (FDA) in their process to approve drugs and policies.  These advisory committees provide advice on specific regulatory decisions, such as product approvals, and general policy matters, such as regulations and guidance. The FDA however, is not required to follow panel advice when deciding whether to approve new drugs but often does.

Nevertheless, these committees are critical to public health and patients because they provide independent, expert advice on significant scientific, technical, and policy matters that assist FDA’s mission of protecting and promoting the public health. They are also important because they bring high-quality input to FDA in order to support agency decisions. 

However, last year we reported that 218 positions of the 600-plus on FDA's 49 advisory committees had yet to be filled, in part because the FDA tightened guidelines in 2007 to minimize industry ties that could sway a panelist's view.

Consequently, to address this issue, Dr. Margaret A. Hamburg, Commissioner of the FDA, sent a letter to colleagues and staff regarding the disclosure of financial conflicts of interest (COIs). The purpose of her letter was to share her perspective on “the challenge of assembling top experts to advise the agency while maintaining the integrity of FDA’s decision making processes. It also served as a message to make staff aware of “a new draft guidance on transparency and advisory committees,” which she hopes will address these challenges.  Another guidance on transparency related to advisory meetings was published earlier this year.

In putting together advisory committees, FDA can grant waivers for experts, but may not exceed a cap set in the law on the number of waivers to be granted. For fiscal year 2010, this cap was set at about 13% of all advisory committee members participating in advisory committee meetings.  Last year, Dr. Hamburg confirmed this by noting that the FDA was “granting waivers for less than 5%.”

What is perplexing about the recent exchange regarding the potential for COIs on FDA advisory committees is that a study published over 5 years ago dispelled much of the concern FDA officials have.  Specifically, a study conducted in 2006 in the Journal of the American Medical Association (JAMA) examined this issue and published an article titled, “Financial Conflict of Interest Disclosure and Voting Patterns at Food and Drug Administration Advisory Committee Meetings. 

The study examined a total of 221 meetings held by 16 advisory committees. Of the committees studied, 7 of 16 were able to keep their conflict rates at or below 20%. The research also found that only 28% of advisory committee members and voting consultants combined disclosed a conflict. Overall, the study reported that the meeting-level analysis did not show a statistically significant relationship between conflict rates (“index conflict,” “competitor conflict,” or “any conflict”) and voting patterns.

In other words, the researchers tested for a relationship not between conflict of interest and yes votes on a drug but between conflicts of interest and votes for the interest of a pharmaceutical company. Moreover, the research indicated that in all 3 conflict categories, the exclusion of advisory committee members and voting consultants with conflicts would have produced margins less favorable to the index drug in the majority of meetings, but this would not have changed whether the majority favored or opposed the drug. 

From these findings, the researchers concluded that a weak relationship between certain types of conflicts and voting behaviors was detected, and that excluding advisory committee members and voting consultants with conflicts would not have altered the overall vote outcome at any meeting studied.


Despite this research, a recent speech given at the Reuter’s Health Summit last week predicted that the current problems with FDA advisory committees might not be changing.

Discussion

Speaking during the summit, Janet Woodcock, the head of the Center for Drug Evaluation and Research was quoted as saying that she expected drug approvals to increase this year, but that the financial conflict of interest standards for advisory committee membership has made recruitment difficult.

The FDA has approved 12 novel drugs so far this year. Woodcock said she thought the total would top the 21 cleared by the FDA drugs division last year.  The yearly total remains far below the 53 new medicines cleared in 1996 during a boom for drugmakers.

Dr. Woodcock noted how “financial conflict of interest guidelines made it tough to find knowledgeable people to serve on advisory panels that provide recommendations on experimental drugs.”  She recognized that it is “a concern for all our staff.”

She added that, “the issues are very complex. Generally we want people with expertise in doing clinical trials who understand all the issues involved.”  However, many times the top experts in a field are the ones drugmakers hire as paid speakers or consultants.

"There is no doubt it is difficult finding highly experienced people who do not have conflicts," Woodcock said. Instead of the advisory panel process, Woodcock said she “would prefer to see more panel discussions of general policy issues such as approval standards for a specific area.”

Conclusion

The reality is, there is no difficulty finding experts, rather, it is that “some meetings require expertise that is limited to a handful of experts,” the majority of which put their expertise into collaboration with industry.  Since FDA is having such a difficult time finding experts with the appropriate training and background to provide the agency with informed advice, maybe it’s time for FDA to rethink its guidance on this issue, especially if the agency wants to meet its goal of approving more than 21 drugs this year.

While FDA officials are concerned that the agency’s decision making can be undermined if FDA is perceived to rely heavily on conflicted experts,” this concern is misplaced.

According to the most recent data, the rate of vacancies on FDA advisory committees was 25 percent and inched downward to just 23 percent in November and December.   In CDER, vacancies on committees were 27 percent last October, 26% in November and 25 percent in December.  At the Center for Biologics Evaluation and Research (CBER), the vacancy rate was a consistent 32 percent during those same three months. And at the Center for Devices and Radiological Health, vacancies were 28 percent, 22 percent and 19 percent, respectively

With vacancy rates such as these, the FDA will likely be causing unnecessary delays in drug and device approvals, which will only hurts patients. Accordingly, FDA must ask, what undermines their agency more, hiring experts for panels who disclose their financial interests that have no impact on votes, or delaying treatment and patients to Americans?

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I once had to get physicians to disclose their conflicts of interest for a medical journal paper of which the subject was lack of disclosure of conflicts of interest over a highly contentious issue. They balked at disclosing their own interests because they did not view them as conflicted and were somewhat offended that anyone could think they were.

After that experience, I have long felt that required disclosures should not be referred to as "conflict of interest" disclosures. That term itself is offensive and implies lack of integrity in decision making. It causes some not to properly disclose all areas of interest from which they generate income. This is because many view those with opposing views to be conflicted, with their own merely being honorable areas of interest.

It should be "interest" disclosures with catagories to disclose such as ten years worth of:
Federal and state grant/contract funding
Expert witness fees
Corporate/non-profit contracts/grants
Other state/federal/non-profit committees they serve
Association memberships/offices,
Sponsored speaking engagements, etc.

If the word "conflict" were removed from required disclosures, I think it would go a long way toward more accurately reflecting one's motivation for wanting to sit on a particular committee without offending anyone that they must disclose their interest in detail.

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