It’s time for change at the FDA, say expert panel

The FDA needs structural and cultural changes to align the agency with its original mission to act as an independent government regulator of the food and pharmaceutical industries, according to a panel of experts.

Their call for change was based on the FDA’s “eroded” reputation as the gold standard in drug evaluation, which has been weakened over the past decades by legislation, regulation, external pressures and practices. internal, argued Sharon Batt, PhD, of Dalhousie University. in Halifax, Nova Scotia, Canada, and Adriane Fugh-Berman, MD, of Georgetown University Medical Center in Washington, DC, in a report published by PharmedOut, a project of Georgetown University’s Department of Pharmacology and Physiology.

“We recognize that the FDA is under tremendous demand in the face of two pandemics, multiple public health crises,” said Reshma Ramachandran, MD, of Yale School of Medicine in New Haven, Connecticut, who is part of the group. work of PharmedOut. , during a round table. And that’s on top of the agency’s regulatory workload across a large group of industries, she added. “However, at the end of the day, it’s clear that there needs to be a truly independent FDA.”

Batt and Fugh-Berman outlined four areas where the agency should consider changes to bring it back in line with its mission, including transparency and accountability, commitment to innovation, standards of evidence for commercialization of drugs and value in the broader healthcare landscape.

They said that to improve transparency and accountability, the agency should clarify the conflicts of interest of each member of the advisory board, increase the diversity of opinions of those members when grappling with politically charged issues, and minimize the use of guest speakers with ties to a drug sponsor.

Additionally, they highlighted the need for clearer internal and public communications from the FDA about the complexity of drug approval decisions, including sharing any concerns reviewers may have had about a drug approved after the process.

The authors also recommended using the term “innovation” accurately when applied to new drug approvals, noting that the term is commonly misused to describe all agency-approved drugs, especially when they are granted according to an accelerated approval procedure.

Panelist John Powers, MD, of the George Washington University School of Medicine, who is also on the task force, stressed the need for greater transparency in these expedited approvals.

“You want to call it what it is. It’s conditional approval,” Powers said. “We don’t know the evidence is there yet, and some of these things, like breakthrough therapies, almost seem wrong at first glance. You can’t know something is a breakthrough the moment they give that designation.”

Task force member Susan Molchan, Walter Reed National Military Medical Center in Bethesda, Maryland, noted that how the FDA describes its processes and designations can have profound implications.

“Language is important,” she said. “FDA, who are they working for? More and more it looks like corporations against valuing public health.”

To further improve the standards of evidence for approvals, the authors recommended that the agency rely more on clinical trials that directly compare different drugs, as opposed to the standard use of placebo comparisons.

This reliance on comparing placebos and accelerating new drug approvals is problematic, Powers suggested.

“In the current era, the focus seems to be more on getting drugs to market quickly and on the quantity of drugs approved, on the premise that more is better and access is better for patients, although it is unclear whether these interventions improve the patient. results,” he said.

Overall, Batt and Fugh-Berman suggested the agency needs to focus on approving new treatments that are “truly innovative” based on evidence that sufficiently assesses the therapy’s usefulness for patients.

The wide range of recommended changes will need to be enacted by an equally broad coalition, they added. They expect these changes to require legislative efforts, as well as updates to internal policies and cultural shifts in how the agency interacts with industry representatives.

Still, they wrote that they were “optimistic” about the agency’s ability to make those changes and reaffirm its mission to improve the lives of all Americans.

  • Michael DePeau-Wilson is a reporter on the business and investigative team at MedPage Today. It covers psychiatry, the long covid, and infectious diseases, among other relevant US clinical news. Follow

Disclosures

The report was supported by Arnold Ventures.

The authors did not report any financial information.

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