More committees with less conflicted members may increase regulatory safety.
While most consumers may know about the U.S. Food and Drug Administration (FDA) and what it is supposed to do, many consumers may not have the most confidence in the agency. According to a recent survey, more than half of respondents had a negative view of the FDA’s role in regulating the importation of safe prescription drugs, and nearly as many respondents had a negative view of how well the agency regulates the safety of prescription drugs in general.
A report from the Institute of Medicine (IOM) lays part of the blame for FDA’s tarnished reputation on the agency’s perceived lack of transparency and accountability. To stimulate a change in how consumers perceive the agency, the IOM encouraged the FDA, among other recommendations, to use public advisory committees more often, preferably before or soon after approving drugs. By more frequently seeking the opinions of medical experts, knowledgeable industry members and interested consumer advocates through public advisory committees, the FDA, IOM argued, could stimulate greater expertise and greater transparency for the agency, with a goal toward improving the quality of FDA decisions and enhancing public confidence in the agency.
In a chapter in the recently published book, Regulatory Breakdown: The Crisis of Confidence in U.S. Regulation, Susan L. Moffitt, an assistant professor of political science and public policy at Brown University, attempts to bring empirical rigor to bear on the debate over the function of public advisory committees in the regulatory process. Moffitt analyzes the FDA’s use of public advisory committees in its approval of new drugs from 1986 to 2009. Her study evaluates both when the agency uses advisory committees and how the information exchanged during committee deliberations influences regulatory policy decisions.
Overall, Moffitt found, as FDA has suggested, that innovative drugs with possibly uncertain effects—what the FDA terms “priority” drugs—were substantially more likely than other drugs to have a pre-approval advisory committee review. This result seems to indicate that the FDA is using public advisory committees at least when it would seem to matter the most—for so-called “close call” approval decisions.
To test how a public advisory committee may lead to safer drugs, Moffitt focused on the relationship between drugs that received a committee review and whether those drugs either required a new warning label or caused safety alerts after going to market.
Armed with this dataset, Moffitt also evaluated the statistical effect of having members on the committee with potential conflicts of interest, which the FDA allows if the member applies for and receives a waiver. Moffitt compared the post-market safety results of public advisory committees with members who received such waivers to those with fewer or no conflicted committee members.
The data revealed that drugs receiving public advisory committee attention in which the members had no conflicts of interests were far less likely either to require new boxed warnings or to have caused drug-specific safety alerts than those with conflicted members on the public advisory committee.
While recognizing the limitations of the study, including a small sample size of public advisory committees, Moffitt interprets the data to suggest that “fewer post-marketing safety problems [arise] when drugs are reviewed by committees with few conflicts of interest.” These results seem to confirm that FDA may want to use public advisory committees more frequently—and include fewer members with potential conflicts of interest—as a way to overcome the public’s crisis of confidence in the agency.
Moffitt cautions, however, that the use of public advisory committee alone is not a panacea. Instead, she describes it as “only a partial antidote for the systemic challenges facing the agency,” which critics have seen as including the FDA’s continued reliance on industry experts and its much-maligned monitoring of adverse drug effects. Nevertheless, as a way to facilitate both decision-making transparency and the exchange of information, Moffitt suggests that the FDA may want to continue to use public advisory committees to increase drug and overall regulatory safety.
This post is part of The Regulatory Review’s three-week series, Regulatory Breakdown in the United States.