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Duke experts caution against loosening FDA regulations

President Donald Trump has made cutting back on Food and Drug Administration regulations a priority, but what are the potential costs?

In his Feb. 28 speech to Congress, Trump called for “slashing the restraints” from the FDA's “burdensome” drug approval process. He pointed to a 20-year-old student who survived Pompe disease as an example of the benefits when treatment is allowed to reach patients sooner rather than later. But Duke faculty said that Trump’s efforts to slash FDA regulations could have dangerous consequences.

“The president is complaining about the FDA being slow and overly cautious, and I think the president is right about that critique of the FDA of 20 years ago, but I think that’s not true of the FDA today,” said David Ridley, faculty director of the Health Sector Management program. “In the past, the FDA was too slow approving all drugs and set too high a bar for some breakthrough drugs, but today the FDA is faster reviewing all drugs, and also gives some shortcuts to breakthrough therapies.”

In a recent interview with ABC11, Dr. Steven Patierno, deputy director of the Duke Cancer Institute, said he believes that these regulations are in place to “balance patient safety with entrepreneurship.”

Dr. Robert Califf—who was FDA commissioner for a year but resigned after Trump took office—told The Chronicle that rhetoric about loosening drug approval requirements is "misplaced and incorrect."

“Shortening and expediting is a great idea, but it needs to be done without lowering the standards,” said Califf, who is now the Donald F. Fortin professor of cardiology at the DCRI.

He pointed out that more than 90 percent of drugs that enter clinical trials currently do not make it to the market. If regulations are loosened to approve those, he said “a lot of people are going to get hurt or end up taking ineffective drugs.”

Instead, improving patient engagement earlier in the process would lead to faster recruitment in clinical trials, he said. Ridley also noted that public confidence in FDA-approved drugs could be undermined if they do not undergo proper scrutiny. 

And there are protocols in place to expedite drug approvals when there are no currently available treatments, Califf said, citing one of the most controversial decisions during his year-long tenure.

Despite many concerns raised about a lack of rigorous scientific data, the FDA approved a Sarepta Therapeutics drug in September for treating Duchenne muscular dystrophy. Califf deferred to the judgment of Dr. Janet Woodcock—director of the FDA's Center for Drug Evaluation and Research. In doing so, he also noted that the lack of alternative treatments was a consideration.

“If you have a serious disease with no treatments, the law already enables the FDA to expedite drug development,” he said.

A new commissioner

On March 10, Trump announced his nomination for the next FDA commissioner—Dr. Scott Gottlieb. Gottlieb has formerly served as the FDA's deputy commissioner for medical and scientific affairs during the George W. Bush administration. 

Although Gottlieb’s history of supporting lowering FDA regulations has been the subject of criticism, Califf said Trump’s other reported potential picks could have been worse.

“I think people [in the scientific community] are breathing a sigh of relief,” Califf said. “[Gottlieb] knows the FDA, he knows the industry.”

Although FDA commissioners naturally differ by administration, Califf said that the commissioners actually "come out agreeing with each other on almost everything." This includes the regulatory process itself and how it needs to operate independently of politics. 

"The club of former FDA commissioners is in constant communication," he said. "We’ll certainly be weighing in [on issues]."  


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