Taxpayers Hoping for Healthy Dose of Oversight at FDA Hearing

As the U.S. House of Representatives’ Committee on Oversight and Accountability convened a public hearing today with Food and Drug Administration (FDA) Commissioner Robert Califf on a variety of topics, the National Taxpayers Union (NTU) urged lawmakers on the panel to carefully scrutinize the fiscal and regulatory aspects of the agency’s mission and operations. NTU President Pete Sepp offered the following observations.

“FDA oversight and accountability is often conducted in the interests of consumers and patients,  but public officials should bear the interests of taxpayers in mind as well. The agency’s total program funding level is well above $6.5 billion, funded by the nation’s taxpayers as well as ‘user fees’ from regulated companies seeking product approvals. Between Fiscal Years 2017 and 2022 alone, FDA’s appropriations (not counting supplemental funding) rose by more than 20 percent, while user fee collections skyrocketed by nearly 50 percent.  These trends alone deserve careful scrutiny, to ensure that Americans are getting the value they deserve from FDA’s activities, and in many cases the answer is a resounding ‘No.’ 

As an NTU-led coalition noted last year, FDA’s approval procedures for new prescription drugs and other medical breakthroughs have remained mired in practices no longer suited for the research and development pace of the 21st Century. Other parts of the Department of Health and Human Services offer both practical lessons – and cautionary tales – for how FDA can and should do better.

Meanwhile, consumer products that could reduce public health harms – such as alternatives to combustible tobacco – continue to languish in FDA approval mazes and delays that create countless millions of dollars in red tape. In addition, the Biden Administration has even gone as far as to propose bans on flavored tobacco and alternatives, which fail to learn from the mistakes of tax policies over many years.

Many of these smoking-alternative products already face attempts at the state level to impose punitive, discriminatory tax burdens and product bans. FDA should not pile onto those burdens with equally punitive, discriminatory regulation and approval processes. A few states are finally seeing the light, while other countries’ regulators have embraced a wide range of options to combustible cigarettes and tobacco harm reduction. Why can’t Americans have this informed freedom of choice?

Aside from public health, FDA’s actions – or lack of actions – have much larger, indirect effects on the fiscal health of the nation. Prescription drugs for conditions such as heart disease, diabetes, and obesity can over time reduce other costs such as surgeries and hospital stays within taxpayer-funded health care programs. Tobacco harm reduction can reduce some treatment costs as well, while allowing many Americans to enjoy more productive taxpaying lives. 

Oversight and Accountability Committee members should ask Commissioner Califf some serious questions about whether FDA’s strategies are based in sound science and economics, or ideology. Taxpayers are waiting for answers.”