In 2012, Congress passed the FDA Safety and Innovation Act, reauthorizing the regulatory agency’s longstanding practice of collecting user fees from the companies whose products it reviews. The legislation also loosened restrictions against individuals with conflicts of interest from sitting on FDA advisory committees — a development that could lead to inaccurate assessments of potentially dangerous drugs and medical devices, according to a paper published last week in the journal Science.
FDA advisory committees are panels of “external experts” who provide guidance and recommendations on products up for review. The FDA generally bans people with conflicts of interest — such as individuals with a financial stake in the product — from being a part of these committees, though it does grant waivers that allow their participation under certain circumstances. After scientists complained that the waivers undermined the objectivity of the review process, the FDA instituted caps on the number of waivers it could grant in 2007. The 2012 legislation removed those caps and amended several other requirements under the assumption that individuals with conflicts of interest have higher levels of expertise and are easier to recruit than nonconflicted individuals.
A couple of studies from 2006 and 2009 support removing the caps — both found that there was no significant difference in the voting patterns of advisory committees with and without members who reported conflicts of interest. But the authors of the current paper, Susan Wood and Jillian Mador of George Washington University, counter with a 2009 Institute of Medicine report, which concluded that conflicts of interest threaten “the quality of patient care.” Another report from 2006 found that individual committee members can exert disproportionate influence on product decisions.
Evidence of the potential harm posed by conflicts of interest can be seen in recent high profile regulatory failures. After reports that the contraceptive pills Yaz and Yazmine had increased women’s risk for blood clots and caused several deaths, the FDA convened an advisory committee to assess the medications’ safety. The committee voted 15 to 11 to keep the drugs on the market, but four members were later revealed to have undisclosed conflicts of interest. By April 2012, Bloomberg reported that settlements related to Yaz and Yazmine associated injuries had reached $142 million.
In another instance, when an FDA advisory committee reviewed the painkillers Bextra, Celebrex, and Vioxx after they had been linked to strokes and heart attacks, 93% of the committee members with conflicts of interest voted to approve the drugs, compared to 56% of members without conflicts of interest.
Wood and Mador point out that the limit on conflict of interest waivers has never been reached, so it is unclear how removing the caps would make the committees more efficient. And even if efficiency is improved by loosening the conflict of interest restrictions — is it worth it if the trade-off is safety?