Former FDA commissioner warns about losing a generation of scientists

Recent cuts at the US Food and Drug Administration (FDA) and other scientific agencies such as the National Institutes of Health (NIH) could have dire consequences for the future of US research and innovation, according to former FDA Commissioner David Kessler.

Kessler was one of several experts who testified at a House Oversight Committee hearing on 9 April about the FDA and its oversight of illicit products entering the US.

Committee Chair James Comer (R-KY), opened the hearing by arguing that under the Biden administration FDA had pushed burdensome gender identity requirements on clinical trial sponsors, which made compliance more expensive. He also said the previous administration had ignored the infant formula crisis and the importation of illicit products.

"The Biden administration stifled innovation with red tape and put bureaucrats before the health of the nation. Reform is essential,” said Comer. “The FDA must prioritize innovation, safety, and the health of all Americans.

“The FDA needs better systems to identify and address drug shortages, quick approval of medicines and techniques identified with [artificial intelligence] in support of President Trump's promise to cure cancer is a necessity," he added. "Incentivizing domestic manufacturing of pharmaceuticals is essential to improving the safety of prescription drugs and will enable more research."

Kessler, who served as FDA commissioner under Presidents George W. Bush and Bill Clinton, said that President Trump’s recent cuts to the Department of Health and Human Services (HHS) and FDA means there are fewer resources to counter illicit products and regulate products on the US market.

"This feels a little surreal just sitting here because everybody wants a stronger FDA, everybody wants more regulation, fix this, make sure that infant formula is safe, …, do a better job, go here, go there, make sure this import doesn't contain any harmful products,” said Kessler. “But over the last several weeks, this agency has been devasted."

He noted that Peter Stein, former director of the FDA Office of New Drugs (OND), who was fired as part of Trump’s reduction in force (RIF) initiative, also saved the president’s life by contributing to the authorization of monoclonal antibodies used to treat him when he contracted COVID-19.

“These cuts to me seem as devastating, haphazard, thoughtless and chaotic,” said Kessler. “Mr. 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.”

Kessler noted that only 4% of active pharmaceutical ingredients are made in the US, while 80% are imported from China and India. He also warned that imported compounded versions of GLP-1 drugs used for weight management currently are not being sufficiently inspected by FDA, leading to safety risks.

According to Kessler, China's bigger threat is that it is surpassing the US in the sciences. He noted that according to the Nature Global Index the top eight global universities conducting research in the natural sciences and the top 10 universities in chemistry are in China. For now, the US only holds the lead in health sciences, he added.

"Do you want China to eat our lunch when it comes to science and innovation?” Kessler asked. “We need to understand that China is poised to surpass us in the sciences, and we need to quickly act to make the necessary investments to shore up our competitiveness and avoid putting our nation at risk."

Kessler said the recent cuts at HHS, and especially at NIH, could have dire consequences as young scientists who relied on NIH funding for their research suddenly lost that funding.

"This is about expertise, this is about pipeline,” said Kessler. “We're going to lose a generation of scientists that's going to set back this country, and that's [also] true at FDA.

“We've lost a thousand person-years of expertise in a few weeks,” he added. “If we let this go on, in a matter of weeks, this may not be fixable, this may affect us for decades.”

Not everyone agreed with Kessler’s dire warnings. Richard Williams, a senior affiliated scholar at the libertarian think tank Mercatus Center and former director for social sciences at the FDA Center for Food Safety and Applied Nutrition, argued that fewer staff would mean fewer regulations, which ultimately could be better for the US economy.

“FDA justifies budget increases with the same information every year coupled with new challenges, but increased funding for FDA means more regulations, more control over the economy, and higher prices,” said Williams. “I don't think people care about giving FDA more money or seeing them exercise greater control; they just want safe and healthy food.

“FDA needs to cut out ineffective programs and regulations and going forward needs to produce far fewer regulations,” he added. “If we cut out useless programs and we have far fewer regulations, resources will be freed up to meet new challenges.”

Former FDA commissioner warns about losing a generation of scientists

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