Tag: news

In a new op-ed published in the HPHR Journal, The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) Director Brian King writes about what the FDA is calling “health equity.” However, missing from the editorial is any response to either the recent Reagan-Udall Review or the findings of a recent investigation into the CTP by the U.S. Office of Special Counsel (OSC).

In the editorial, King writes that “there is no safe tobacco product; however, products do exist on a continuum of risk, with combustible products being responsible for the overwhelming burden of disease and death from tobacco use.”

He also states that “science is central to informing tobacco regulatory decision making,” noting that he is “a scientist by training” and is “particularly attuned to the vital importance of ensuring we gather and use the best scientific evidence available.”

In writing about his “vision” for the CTP, King does not address memos recently submitted to the U.S. Court of Appeals for the Third Circuit that show King reversed a recommended marketing approval of Logic Technology’s menthol vaping products, ignoring the advice of FDA scientists, according to Logic’s lawyers. 

King also failed to address the conclusion a recent investigation conducted by the OSC that found the CTP had relaxed its standards of review for certain tobacco products and stifled attempts by its scientists to raise concerns. The OSC sent a letter to the U.S. President and Congress outlining the findings.

In the op-ed, King claims that the CTP “strive[s] to engage with a wide array of stakeholders, including those that work with and represent individuals and communities who are disproportionately impacted by tobacco use, to facilitate an open exchange of opinion from diverse groups.”

However, when the Reagan-Udall Foundation submitted its recommendations to Robert Califf , commissioner of the FDA, in December, the report concluded that vaping industry stakeholders observed a lack of “consistent implementation” of what the industry understood to be the policies of the CTP, particularly with respect to tobacco harm reduction and the requirements needed to navigate the premarket tobacco product application (PMTA) process.

King then goes on to state that in the 13 years since the landmark Tobacco Control Act (TCA) was signed into law, CTP has done “significant work to effectively research, regulate, and educate in a complex and rapidly changing tobacco product landscape.”

However, the Reagan-Udall report stated that the CTP needs to make “process improvements and identify and address the policy and scientific questions” that underpin its regulatory framework. The review concluded that CTP’s implementation of its PMTA program also has been affected by “changes in leadership and administrations.”

Since the implementation of the TCA, CTP has operated under seven different commissioners in three different administrations, and recently hired its third CTP director, King. In October, numerous comments from staffers of the CTP for the Reagan-Udall assessment of the performance of the FDA’s tobacco center claimed the regulatory agency is in a state of disarray and being influenced by outside forces, not scientific research.

One comment stated that reviewers of PMTAs in the CTP’s Office of Science (OS) lack the autonomy to exercise “best scientific practices” in their reviews of PMTAs.

“Scientific disagreement is frowned upon, if not entirely suppressed, and punished through various backhanded methods (e.g., lack of assignments, projects, and other opportunities that are needed for career development/promotion),” the comment states. “In some divisions (e.g., Division of Nonclinical Science [DNCS]), leadership pushes a ‘gotta get em’ mentality onto staff, which is unsupportive of a reviewer’s fundamental duty to provide an unbiased review using the best available science.”