Reforming the FDA: Saving Money, Saving Lives
Taxpayers Protection Alliance
October 3, 2019
The Food and Drug Administration (FDA) is responsible for the approval and regulation of prescription drugs, tobacco products, medical devices, and food items. With a $5.7 billion budget for fiscal year (FY) 2019 ($2.6 billion from various user fees), the agency falls short in providing Americans adequate access to the products they need or want. The prescription medication approval process remains languid and demands increasingly-outdated statistical guidelines from drug sponsors. The agency’s “tobacco product” evaluation process focuses more on fear and risk-aversion than evidence-based policy making, and bizarrely includes products such as electronic cigarettes that do not contain tobacco. The FDA often has food guidelines based on politics and hysteria rather than science.
Reforming the FDA: Saving Money, Saving Lives identifies myriad problems with the FDA regulatory process and proposes reforms that can save thousands of lives each year.
- Reevaluate medication safety, and efficacy statistical standards: FDA statistical standards are far too strict which results in promising and experimental medications being denied by the agency even if there is more than a 90 percent probability that the drug will be effective against an illness. The FDA should consider different standards based on the diseases being targeted by medications and allow clinical trials to adopt alternative statistical standards.
- Tighten advisory committee standards: The FDA often relies on outside experts to assess the applications of drugs and medical devices. Unfortunately, positions on these committees are often vacant, resulting in remaining members having outsized influence. Additionally, regular conflicts of interest require routine waivers to be issued by the FDA. Vacancies and conflicts of interest should be strictly limited by the FDA.
- Cease consideration of reducted risk electronic nicotine delivery systems (ENDS) products (i.e. e-cigarettes) as “tobacco products:” Because of rules promulgated in 2016, the FDA considers vaping products as tobacco products, even though they do not contain tobacco. Reduced-risk products such as e-cigarettes are 95 percent safer than cigarettes and treating such goods as tobacco products creates significant regulatory costs and undermines smoking cessation. The FDA should make clear that ENDS products are not tobacco products.
- Reaffirm mandated time guidelines for the premarket tobacco product application (PMTA) process: The last alternative tobacco product submitted for a PMTA took 716 days, well past the agency’s own guidelines stipulating a 180 day evaluation window. The FDA should reaffirm its own evaluation timetables, and publicly promise to maintain an expedient approvals process. To hold itself accountable, the agency should commit to automatically approving any product that it fails to evaluate within the 180-day determination window.
- Revise nutritional guidelines: The FDA’s definition of the word “healthy” centers around the fat content of food products, without taking into account the presence or absence of other nutrients critical to a healthy diet. The FDA should revise its definitions, and use a holistic approach to assess health claims.