Ex-FDA chief warns agency cuts raise illicit product risks

Former FDA Commissioner David Kessler has told lawmakers that sweeping cuts to the FDA and other regulatory bodies in the US are raising the risk of counterfeit medicines, devices, and precursor substances reaching the US.

He told a meeting of the House Committee on Oversight and Government Reform – entitled Restoring Trust in FDA: Rooting Out Illicit Products – that while the total impact of the job cuts on FDA functions is hard to gauge, there are already examples of how they have crippled key FDA functions "particularly regarding oversight of illicit and counterfeit products."

He highlighted the widespread use of compounded GLP-1 receptor agonist therapies – often produced with ingredients imported from China that could make quality shortcuts – describing it as "a reckless national experiment."

While the FDA has said that the number of inspectors has not gone down since the staffing reductions started, Kessler said that preventing potentially unsafe products from entering the US requires nimble, responsive action as bad actors frequently shift their tactics when importing their goods.

"I agree that we need to improve – and yes, streamline – FDA’s oversight and response to illicit products. But the cuts last week are not streamlining. They are not improving," he told the committee.

"If you remove the people doing the work to ensure the safety of products entering this country’s supply chain, it is not hard to project that more illicit and counterfeit products will enter this country as a result of last week’s haphazard cuts."

Citing the example of illegally imported flavoured vapes, Kessler noted that FDA officials with decades of experience came up with a plan to enable regulatory action on products, to which industry objected.

"FDA fought all the way to a victory at the Supreme Court last week. Key staff at FDA’s policy shops and the Center for Tobacco Products, including Center Director Brian King who led this strategy, were all cut last week."

Kessler's comments come after US Health and Human Services (HHS) Secretary Robert F Kennedy Jr said he is planning 10,000 cuts to the full-time workforce at the agencies his department oversees, taking the total reductions to around 20,000, factoring in an already running early retirement scheme, the 'Fork in the Road' scheme of deferred resignation, and the wholesale firing of probationary workers.

"These cuts to me seem devastating, haphazard, thoughtless and chaotic," he told lawmakers on the committee, which is chaired by James Comer (R-KY).

"Mister Chairman, I agree with your priorities of increased enforcement of illicit imports and counterfeits. I agree with your priority of improving the safety of our food. The current cuts will make achieving those impossible."