The Food and Drug Administration recently held an “Advancing Regulatory Science Through Innovation” forum to allow the public to “view the unique scientific research and collaborative efforts of FDA’s 11,000 scientists.” Intended to restore public trust in the agency, it was a bust in at least one important respect. It failed to address the broad public concerns that have arisen over the unscientific regulatory decisions of the agency’s Center for Tobacco Products.
In December, the Office of Special Counsel alerted the president and Congress that the CTP “had relaxed its standards of review for certain tobacco products and stifled attempts by its scientists to raise concerns.” This came on the heels of a leading CTP toxicologist informing the OSC that CTP “directed scientists to stop using objective, quantitative data to evaluate applications and to instead use an approach which was more akin to ‘eyeballing it’, resulting in unclear review standards and less reliable decisions.”
The OSC is not the only government-created body to have concluded that the CTP is ignoring science when conducting its rulemaking. In fact, the same month the OSC tipped off the legislative and executive branches to this concern, a long-awaited agency review conducted by the Reagan Udall Foundation — the nonprofit body created by Congress to work with the FDA — made it clear that the CTP’s rule-making lacks consistency and transparency.
Over the last several years, the issue of the CTP forsaking science when formulating and issuing its product bans has arisen repeatedly.
For example, in April the FDA proposed banning menthol cigarettes even though the menthol smoking rate for minors has decreased to almost zero. Similarly, the CTP is now trying to ban flavors even in premium cigars, which less than 3 percent of Americans smoke every day. (Moreover, FDA-funded studies show that children aren’t smoking premium cigars.) A federal judge ruled in August that CTP’s approach to regulating these products was arbitrary and capricious and vacated the FDA's regulation.
In February, the CTP promised to address many of the concerns raised by the Reagan-Udall report but warned that the process “will take time.” Several months have passed, however, and the agency has yet to show any signs of slowing down its overzealous, illogical regulatory agenda. CTP hasn’t even suspended — let alone withdrawn consideration of — rules that many in the public health community have criticized for having no scientific basis, such as the menthol cigarette and flavored premium cigar bans. Instead, it seems intent on playing damage control by holding forums on its “unique approach to scientific research and collaboration” like the one it conducted last month.
Holding such forums is fine, but they are no substitute for making substantive operational changes. Restoring scientific integrity should be the CTP’s priority. Without it, the agency will continue to face onslaughts of well-founded litigation, distrust from the public, negative press and criticisms from lawmakers that will weaken its operational authority going forward. If the agency were serious about its commitment to protecting public health and promoting health equity, it would immediately permit the sale of menthol e-cigarettes and other flavored lower-risk products that would allow adult smokers from disadvantaged communities to lower their risks from nicotine use.
Fortunately, members of Congress are pressuring the agency to implement much-needed reforms. Rep. James Comer, R-Kentucky, chair of the House Oversight and Accountability Committee, sent a letter to the CTP expressing concern that the agency is being “influenced by political concerns rather than scientific evidence.”
He opened an investigation into the agency’s decision-making process and requested documents that would shed more light on the rationales for the CTP’s rule-making. Other members have introduced legislative fixes that would block the agency from finalizing some of its proposed product bans that lack scientific backing.
We hope these actions from the legislative branch will push the CTP to make the needed corrections. Public health and FDA’s reputation will both be better off for it.
Henry I. Miller, a physician and molecular biologist, is the Glenn Swogger Distinguished Fellow at the American Council on Science and Health. He was the founding director of the FDA’s Office of Biotechnology. Jeff Stier is a Senior Fellow at the Consumer Choice Center.
Henry I. Miller, MS, MD
Henry I. Miller, MS, MD, is the Glenn Swogger Distinguished Fellow at the American Council on Science and Health. His research focuses on public policy toward science, technology, and medicine, encompassing a number of areas, including pharmaceutical development, genetic engineering, models for regulatory reform, precision medicine, and the emergence of new viral diseases. Dr. Miller served for fifteen years at the US Food and Drug Administration (FDA) in a number of posts, including as the founding director of the Office of Biotechnology.
