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Distrust of FDA Drug Approval Process Leads To Hesitation Prescribing New Meds: Survey

A new survey reveals that nearly half of prescribing doctors across multiple specialties do not trust the U.S. Food and Drug Administration’s (FDA) new drug approval process, due to the agency’s lack of consistency and transparency, which results in hesitancy prescribing new medications.

Spherix Global Insights, an independent market research firm, released the results of a new drug approval confidence survey on July 27, finding that more than 40% of physicians said their confidence in the FDA has plummeted over the last year.

The fall in confidence comes following several controversial decisions by the agency to approve new drugs, despite nearly unanimous recommendations against doing so by its independent advisory panels.

Researchers surveyed 252 specialists in dermatology, gastroenterology, nephrology, neurology, and rheumatology to gauge their confidence of the agency’s New Drug Application (NDA) reviews and transparency with the medical community.

According to the results, 84% of neurologists reported that their confidence with the FDA has eroded in the past year, while 43% of rheumatologists, 43% of dermatologists, 38% of nephrologists, and 32% of gastroenterologists also reported declining trust in the agency.

The overall perception of physicians was either a lack in trust of the agency or no change at all in confidence levels, with only 4% of nephrologists, 6% of neurologists, 10% of rheumatologists, 4% of gastroenterologists, and 4% of dermatologists reporting an improved sentiment.

According to the findings, physicians reported an array of problems leading to the distrust in the FDA’s ability to make scientifically sound and safe decisions for approving new patient drugs, including suspected political motivations and a lack of transparency with the medical community.

The report indicates more than 70% of all surveyed physicians agreed the FDA should established new standards for Advisory Committees, with 40% of respondents reporting the agency should be bound to the Committee’s recommendation.

One neurologist who participated in the survey pointed to the recent approval of the Alzheimer’s drug Aduhelm as a sign of why mistrust in the FDA is growing.

“The erosion [of my confidence] is based on the disastrously bad decision to approve aducanumab (Aduhelm), which seems like a poorly developed and even possibly corrupt decision,” he told surveyors. “I cannot remember a similar situation in which there was so much dismay and disbelief created by an FDA decision. We do not plan to use aducanumab at this time and we no longer know what to think about and how much to trust any future FDA decisions.”

The neurologist references the FDA’s recent approval of Biogen’s Aduhelm in early June. The first Alzheimer’s disease therapy drug was cleared despite a nearly unanimous vote against the drug by the agency’s Peripheral and Central Nervous System Drugs Advisory Committee, which found that the clinical trials failed to prove effectiveness, and contained evidence the drug may actually worsen some patients’ conditions.

The FDA was instantly criticized for granting accelerated approval of Biogen’s Aduhelm, with many critics claiming the approval is reckless. As a result of the FDA’s decision to grant approval of Biogen’s Aduhelm, despite the lack of clinical trial data, Washington University neurologist Dr. Joel Perlmutter and Mayo Clinic neurologist Dr. David Knopman, who are members of the advisory committee, resigned from the panel, stating they did not “wish to be part of a sham process”.

Last month, FDA Acting Commissioner Janet Woodcock sent a letter to the inspector general of the FDA, calling for an investigation into the approval of Aduhelm, and into interactions between Biogen and FDA staff. She said such an investigation was warranted given the amount of criticism the FDA has received over the drug’s approval and accusations of an overly close relationship with the manufacturer.

“To the extent these concerns could undermine the public’s confidence in FDA’s decisions, I believe that it is critical that the events at issue be reviewed by an independent body such as the Office of the Inspector General in order to determine whether any interactions that occurred between Biogen and FDA review staff were inconsistent with FDA policies and procedures,” Woodcock wrote.

Past studies have raised concerns about the safety of drugs approved through an expedited process, indicating that new medications that hit the market after going through the FDA’s accelerated approval process are 94% more likely require a safety related label change every year, and had a 48% higher chance of requiring a black box warning or contraindication; the sternest label warnings the FDA can require.

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