In order to achieve results that it believes are vital to public health, the Food and Drug Administration (FDA) has demonstrated time and again that it’s not afraid to trample laws and constitutional rights along the way. Occasionally, judges reintroduce FDA to the Rule of Law. We applaud one such recent rebuke by Judge Richard Leon, whose July 21 Lorillard v. FDA decision reminded FDA that it cannot stack a science advisory panel with members who will tell the agency what it wants to hear.
FDA tobacco control. After the U.S. Supreme Court rejected the agency’s attempt to seize regulatory oversight of tobacco products in 2000 (FDA v. Brown & Williamson), Congress granted FDA the authority it coveted in 2010. Banning or severely restricting the use of menthol in cigarettes has long been a goal of FDA’s friends in the anti-tobacco movement. FDA created a science advisory panel, the Tobacco Products Scientific Advisory Committee (TPSAC) to study menthol. The TPSAC concluded in 2011 that menthol had a negative effect on public health. Two companies filed suit in Febuary 2011, charging that FDA violated federal law by appointing members to the TPSAC who had clear conflicts of interest. The plaintiffs asked the court to strike the TPSAC’s report from the regulatory record.
Judge Leon’s opinion. The TPSAC members in question had ongoing contracts to testify as expert witnesses for plaintiffs in suits against tobacco companies. They also served as consultants to manufacturers of tobacco cessation products. FDA didn’t feel such relationships conflicted with their duties on the TPSAC. Judge Leon was quite flabbergasted by FDA’s decision. “Please!” he exclaimed, adding, “This conclusion defies common sense.” With regard to the members’ work with plaintiffs’ lawyers, Judge Leon explained that they had a financial incentive not to make any recommendations that would compromise the lawsuits in which they would testify. On the product consulting work, the judge noted that any FDA regulation of menthol would likely inspire more smokers to quit, potentially with the assistance of cessation products. Thus the TPSAC members also had a financial incentive to offer advice that would encourage a ban or restrictions on menthol. Judge Leon concluded that such blatant disregard for obvious conflicts violated federal law, and he enjoined FDA from utilizing the report in its assessment of menthol.
A conflict for thee, but not for me? Federal health regulators have a rather flexible interpretation of what constitutes a conflict of interest. FDA and its counterparts at the Centers for Medicare and Medicaid Services (CMS) see conflicts in just about any interaction between medical product makers and health care professionals. The result is a proliferation of disclosure rules, counterproductive curbs on medical education, and life-threatening limits on communicating about so-called off-label uses of treatments. Such regulations preserve and expand FDA’s and CMS’s control over health care decisions.
In 2009, FDA asked the Institute of Medicine (IOM) to create a committee that could advise on agency efforts to improve the review process for medical devices known as “510(k)s.” IOM failed to appoint a single individual who ever had created a medical device, sought 510(k) approval of them, or prepared 510(k) applications. IOM’s rationale: it didn’t want to run afoul of conflict-of-interest rules. That did not, however, stop IOM from including a professional activist from Public Citizen Litigation Group, an organization which has long sought to end the current 510(k) program.
WLF petitioned FDA in 2011, alleging FDA breached the Federal Advisory Committee Act by failing to ensure that IOM’s panel was “fairly balanced.” FDA denied our petition in 2012.
Stop stacking the deck. FDA and other federal agencies have broad discretion to either accept or ignore the recommendations of advisory committees. But such groups of experts provide regulators with a patina of credibility. If experts tell regulators that the science compels action, that conclusion makes agencies’ jobs easier. And what better way to make sure that the science supports regulation than to appoint advisers whose views on the policy issue at stake comport with those of the agency?
Such a deck-stacking approach toward regulation, especially when science is involved, poorly serves the public interest. That’s why federal law requires agency advisory committees to be impartial, and that they not be used to justify a pre-determined regulatory outcome. As we said above, FDA has no problem spotting some conflicts of interest when doing so suits its agenda. When it conveniently closes its eye to other conflicts for the same reason, the judiciary must fulfill its checks-and-balances role, as Judge Leon properly did in Lorillard v. FDA.
Also published at WLF’s Forbes.com contributor page