More than half of American doctors think the U.S. Food and Drug Administration (FDA) approval process for new drugs and medical devices is more rigorous than it actually is, according to a national survey.
The survey, conducted by a research team from the University of California (UC)–San Francisco and the San Francisco Veterans Affairs Medical Center, shows that less than half of doctors have at least a moderate understanding of the FDA’s drug approval process, while just 17 percent reported having at least a moderate understanding of the agency’s medical device approval process.
“Physicians’ understanding of the FDA’s evidence requirements is important, especially given the increasing use of expedited approval pathways for both drugs and medical devices,” the research team wrote.
To determine doctors’ understanding of the FDA approval process, between October 2021 and January 2022, the researchers surveyed 509 physicians actively certified with the American Board of Internal Medicine. They received 478 completed responses from internists, oncologists, and cardiologists. Sixty-five percent of the respondents were male. Many were veterans of the field, with 38 percent reporting they had practiced medicine for between 20 and 32 years. One-third also had ties to the pharmaceutical and medical device field, having received a payment from a drug, device, or other medically related company within the past two years.
Physicians Call For More Stringent Standards and Protocols
More than half of physicians thought the FDA should require that new drugs and devices be approved only after undergoing at least two or more randomized controlled trials. Randomization, which is the random assigning of participants in a study to either the treatment or control group, was the most critical factor in approval for most physicians.
The survey found that most physicians favored requiring that trials include randomization or blinding or meet primary endpoint thresholds to make it to regulatory approval. However, the research team noted that randomization and blinding are “particularly infrequent” in trials for devices and that at least 13 percent of devices that receive premarket approval didn’t meet primary endpoint thresholds. Medication trials fare better, with 75 percent involving randomization and 60 percent involving blinding.
Although most physicians supported the FDA’s Breakthrough Devices Program, they also called for protocol changes. The program is meant to speed up the development and approval process of medical devices that are new and innovative and can dramatically affect or save the lives of patients.
Physicians also noted they were more likely to use or recommend a drug that received a breakthrough designation. Such a designation allows for more flexible study designs. However, one-fourth of respondents said those relaxed rules were, in fact, too relaxed and that “the current bar for FDA approval of most new devices was too low.”
When a drug or medical device is approved with a breakthrough designation, more trials or studies are usually required after going to market. However, the study noted that these postapproval trials are often incomplete or delayed. When they are complete, they often aren’t rigorous enough and fail to address knowledge gaps.
Ninety-five percent of doctors thought the FDA should withdraw approval if postapproval trials don’t show clinical benefits. Dr. Sanket Dhruva, the study’s lead author from UC–San Fransisco wrote that this finding was “particularly intriguing because FDA rarely takes regulatory action for these issues—but physicians want the agency to do so.”
Why Physician Understanding Matters
As the FDA continues to approve higher numbers of novel drugs and medical devices, prescribing physicians must have confidence and trust in the approval process.
A stricter approval process could prevent adverse reactions that trigger investigations, such as the FDA’s current investigation into GLP-1 agonists (such as Wegovy and Ozempic) for potential suicidal ideation, alopecia, and aspiration.
“Physicians would value higher-quality evidence standards to support approval, as well as regulatory action such as withdrawal or banning promotion for drugs or medical devices that do not demonstrate clinical outcome benefit,” the researchers wrote.