Stakeholders Warn Against Deregulation of FDA Approval Process

Reducing FDA standards for drug approvals will harm health everywhere, some experts warn.

President Donald Trump has spoken out about the speed of the FDA’s approval process, saying it is too slow and burdensome. In January, President Trump told pharmaceutical industry executives, “We’re going to be cutting regulations at a level that nobody’s ever seen before.”

In a new report published in Nature, 3 experts said plans to deregulate the FDA testing and approval process would harm health, not just in the United States, but worldwide. Furthermore, deregulation would stifle innovation and “waste patients’ and taxpayers’ money,” according to the authors.

The experts said President Trump’s argument is consistent with a history of neoliberal economics, which claims regulatory agencies are systematically biased towards excessive caution, and that the burden of testing a drug’s efficacy before it comes to market outweighs the benefits.

“They argue that potentially harmful drugs can be identified quickly after they go on sale,” said John Rasko, one of the letter’s authors. Furthermore, that the FDA runs an overly stringent system that withholds or delays safe and efficacious drugs.

Rasko disagrees with these arguments and said they are wrong.

“The most extreme proponents of deregulation say that the market should be the sole arbiter of utility: if a medicine sells well, then it must therefore, be safe and effective.

“A more moderate version of this argument says reliable information on safety and efficacy can be collected after a drug is on sale, through observational studies or using biomarkers.”

But the authors believe lessening the FDA’s regulatory system will subject patients to drugs that could be toxic, citing the infamous thalidomide era, which caused more than 10,000 birth defects worldwide.

“Even in the past dozen years, initially promising drugs, such as torcetrapib (for reducing cholesterol and heart-disease risk) and semagacestat (for improving cognition in people with Alzheimer’s disease), were found to cause harm only after they had been tested in large, mandatory trials—–effects that were not seen in the smaller trials,” the authors wrote.

The authors also cited the issue of safe, but “useless” drugs.

“Untested drugs can be reasonably safe but provide no benefit,” Rasko said. “And unregulated markets are hopeless at sifting out these ‘futile drugs’. We only have to consider the multibillion-dollar industries in homeopathy and other pseudo-medicines to see this.

“The ineffective pills and potions are a massive waste of money and provide false hope to millions of people worldwide. What’s more, for progressive diseases such as cancer or multiple sclerosis, if a doctor were to prescribe a drug that didn’t work, she’d be giving a disease a free pass.”

The authors stressed that the current regulatory system is working well. Earlier this year, the FDA released a report identifying 22 products that initially showed promise, but proved disappointing in later-stage clinical trials: 14 for lack of efficacy, 1 for lack of safety, and 7 for both safety and efficacy.

Rasko noted the importance of considering how far the industry has come with the help of agencies such as the FDA.

“In 1938 US Food, Drug, and Cosmetic Act required only that drugs demonstrate safety,” Rasko said. “In 1962, new legislation demanded that marketed drugs also go through well-controlled studies to test for therapeutic benefit.

“More than 1000 medical products were subsequently withdrawn after reviews found little or no evidence of efficacy. The free market that existed before 1962 revealed no connection between a drug’s ability to turn a profit and its clinical usefulness.”

The experts warn history may repeat itself if the future holds a deregulated market.

“Patients and doctors must have access to reliable information to make educated and ethical choices,” the authors wrote. “But reliable information costs money and no one will invest in producing good quality evidence if they can make the same profit on a drug or technology without it. Rigorous clinical studies are still the best way to learn whether a drug works, and regulation is essential to ensure that these studies are conducted.”