Kennedy’s FDA Continues Big Pharma Corruption

Back in February, newly-confirmed Secretary of Health and & Human Services (HHS) Robert F. Kennedy Jr. promised to reverse decades of industry capture of the public health agencies. Yet, recent moves by the Food & Drug Administration (FDA) strongly suggest more of the same: faster approvals with less evidence of safety and effectiveness resulting in exorbitant, ill-gotten Big Pharma profits.

Calling institutions like the FDA sock puppets for industry, Kennedy has spent years railing against how powerful pharmaceutical companies work with the federal government to corrupt the drug approval process.

These criticisms are correct. The agency has been institutionally corrupted by the drug companies it is meant to regulate. Every former FDA commissioner except one since the 1980s has gone on to work for the pharmaceutical industry. Around halfof the agency’s budget comes from those very drug companies in the form of user fees, and the same is true for two-thirds of its budget for human drugs.

Companies don’t just pay the agencies, they actively negotiate with agency officials to give higher payments in exchange for regulatory favors. They enjoy immense leverage; user fee funding sunsets every five years, which means that failed negotiations can lead to the FDA facing financial catastrophe.

The signature goal of the pharmaceutical industry’s dealings with the FDA has been to secure faster approvals for its drugs while providing less evidence that they are safe and effective. This has come through the FDA approving more drugs in expedited programs and requiring weaker clinical trials to back their approval.

Indeed, regulators now strive to meet performance goals ironed out with industry. Rather than ensuring drugs are safe and effective, these goals are squarely focused on reviewing drug applications faster. Faster approvals have led to increased safety issues such as issuing drug label changes and black box warnings.

Yet, one of the FDA’s central initiatives is to dramatically reduce application review times through the Commissioner’s National Priority Voucher program. Currentindustry-negotiated performance goals have the FDA reviewing standard new drug applications within 10 months and priority applications in 6 months. This new voucher program would shorten reviews for drugs hand-selected by agency leadership to 1-2 months.

A recent investigation by The Lever conservatively estimated that among the clinical trials backing 427 FDA drug approvals from 2013-2022, 72 percent did not meet one or more of four key standards to show they actually proved that the drugs were safe and effective. For example, most trials did not actually measure the clinical benefit the drug is supposed to provide. Nearly half of all approvals only relied on a single trial, meaning there was no trial replicating proof of benefit.

While Secretary Kennedy has denounced the replication crisis in science – the widespread failure to reproduce study findings – the FDA has moved to exacerbate it. The agency is planning to approve even more drugs based on a single clinical trial without replication.

This move builds on the very industry capture Kennedy has denounced, as industry used its financial leverage during negotiations for the very first user fee reauthorization in 1997 to lower the required number of trials for FDA approval from two to one. The number of approvals relying on just one trial ballooned from a quarter from 1995-1997 to over half by 2015-2017.

Lack of replication is especially problematic given that industry funds the trials meant to prove safety and effectiveness. Substantial evidence shows that industry-sponsored research is significantly biased to provide industry-favorable findings.

Industry controls the results from these trials and predominantly does not provide the full results data to anyone outside the FDA. Thus, medical journals – which doctors rely upon to guide how they treat their patients – act as drug company marketers, publishing their trial results without truly vetting their accuracy. The FDA has the legal authority to make these trial results public – fulfilling Secretary Kennedy’s promise of radical transparency – but the agency has not done so.

The FDA not prioritizing proof of safety and effectiveness along with lack of transparency has had deadly consequences. The case of Vioxx alone – where the FDA did not require sufficient safety testing and the New England Journal of Medicine published faulty industry trial results – resulted in the deaths of an estimated 40,000-60,000 Americans.

Faster approvals with weaker evidence were the priorities of the previous agency leadership that Kennedy has declared were captured by industry. And Secretary Kennedy has cited estimates that adverse drug reactions are among the four leading causes of death in the United States, lambasted industry-funded research, and remarked that “the disastrous health of the American people was no longer a mystery” after learning of FDA user fee funding.

Yet, these FDA actions under his leadership do not reflect an agency dedicated to reversing industry corruption – rather, they show one committed to continuing it. For the FDA to change from being a sock puppet of industry, its leaders must reverse the decades-long trend of regulators relying on industry money and prioritizing industry demands of faster approvals for drugs without truly proving they are safe and effective.

This first appeared on CERP.

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