Tomorrow morning, the beleaguered head of the Food and Drug Administration’s Center for Tobacco Control (CTP) Brian King, will be forced to testify before the House of Representatives Energy and Commerce Health Subcommittee on the multiple failings of his agency.
This hearing is as a result of lawmakers multiple frustrations and the CTP’s refusal do the job Congress and taxpayers have tasked it with, and could not come soon enough. Under King’s leadership, the CTP has lurched from scandal to scandal.
Multiple whistleblowers amongst the agency’s staff repeatedly cried out it is placing politics above science in its approach to tobacco policy. The full bench of the U.S. Court of Appeals for the Fifth Circuit delivered blistering judgements on how the agency acted in “arbitrary and capricious” manner, while an independent review by the Regan Udall Foundation found it “struggled to function as a regulator” with a “deep culture of systemic problems“.
Is it any wonder polling has shown a staggering 76% of Americans demand urgent FDA reform, with a particular focus on the agency failures to embrace tobacco harm reduction?
At issue is CTP’s failure to fulfill its statutory requirements under the Family Smoking Prevention and Tobacco Control Act of 2009 to authorize new technologies to help smokers quit – products evidence shows are overwhelmingly appropriate for the protection of public health. These new nicotine delivery systems are shown conclusively to be 95% safer than deadly combustible cigarettes and multiple times more effective than other forms of nicotine replacement therapies. According to the best analysis from cancer researchers worldwide compiled by Georgetown University have the potential to save 6.6 million lives over a ten-year period yet King’s FDA continues to fail to allow them for legal public sale.
International best practices and academic evidence clearly show the need for governments to fast-track the approval of products that help smokers quit, whether it be through electronic nicotine delivery systems, devices which heat rather than burn tobacco, nicotine pouches, or other technologies, while currently the CTP is doing just the opposite.
In addition, as Americans for Tax Reform has extensively documented, the CTP as has failed to act with transparency and predictability. Taxpayers remain in the dark as to how over $700 million in fees collected by the agency are spent. The Premarket Tobacco Product Application (PMTA) process has created impossible administrative burdens on applicants and an unacceptable backlog with applications waiting for years in review.
Furthermore, the agency’s failures to educate the public about the continuum of risk in nicotine products – despite their own internal documents demanding the need to do so – has meant that 75% of Americans inaccurately believe vaping is equal to or worse than smoking. The fact that the agency’s leadership continues to ignore its own Comprehensive Plan for Tobacco and Nicotine, where harm reduction is supposed to play a central role in the FDA’s tobacco control plan, is a downright scandal.
Tuesday’s hearing is a rare chance for our elected representatives to get accountability from a bureaucrat who has actively failed in his mission to protect public health. By placing private ideological opinions above science, and creating a culture so toxic and dysfunctional, the present CTC it is literally putting million of lives at risk. We hope that this hearing will not only pressure the CTC to authorize life-saving products, but also be the start of a national conversation about structural reform so it may once again return to its core function of promoting public health in the United States. Millions of lives quite literally depend upon it.