麻豆传媒

Many physicians have only a hazy understanding of the FDA's approval process for new drugs and medical devices, a national survey found.

Of 509 physicians surveyed, 41% reported a "moderate" or better understanding of the FDA's drug approval process, and 17% reported the same for the medical device process, Sanket Dhruva, MD, MHS, of the University of California San Francisco and the San Francisco Veterans Affairs Medical Center, and colleagues reported in the January issue of .

Moreover, around two-thirds of physicians thought the FDA's current bar for the approval of new drugs and devices was "about right," at 59% and 66%, respectively, as opposed to too high or too low.

Most physicians also felt that the evidence required for FDA approval of drugs or devices should be two or more randomized controlled trials, though most were aware that the evidence requirement for FDA approval could be a single randomized controlled trial, as in the case of some expedited approval pathways.

"Many of the physicians we queried felt that the FDA has become more lenient overtime," Dhruva said in a . "Physicians need – and want – to know if a drug or device was rigorously studied before they can make recommendations to their patients."

For products approved through expedited pathways, like FDA's accelerated approval and breakthrough device programs, most physicians thought the agency should require post-marketing studies, and should withdraw approval or prohibit advertisements and promotion of the drug or device, if they failed to demonstrate safety and effectiveness.

"Misconceptions about the meaning of FDA approval and breakthrough terminology could lead physicians to mistakenly assume that all new drugs and devices have evidence of clinical benefits," Dhruva and colleagues wrote, "which means that physicians cannot accurately advise patients about uncertainty, benefits, and harms."

Prior research has shown that of physicians thought FDA drug approval meant comparable effectiveness to other approved drugs, and that only drugs with statistically significant and clinically important effects were approved, though this is not the case.

In recent years, the FDA has increased the use of to make drugs and devices available to patients earlier, based on evidence from smaller and fewer trials, or trials that assess surrogate measures, as opposed to , the researchers noted.

"It was not surprising to find that physicians overwhelmingly felt that randomization, blinding, and meeting primary endpoint thresholds were important characteristics of trials used to support regulatory approval," the authors wrote. "Despite these preferences, the proportion of studies leading to FDA approval that feature these characteristics has fallen in recent years."

Researchers recommended more education on FDA approval processes as requirements for accreditation of medical education programs, inclusion of this information in continuing medical education, or expanded FDA efforts to include relevant approval data in clinical practice guidelines for medical products.

From 2021 through 2022, researchers sent email surveys to U.S. physicians board certified in internal medicine, medical oncology, or cardiovascular medicine, sampled from an American Board of Internal Medicine list. They designed the survey with input from experts in survey development that covered physicians' perception of FDA approval, characteristics that physicians think are important among studies supporting FDA approval, views about expedited FDA development or review, and views about moderate-risk devices. Participants received a gift card and up to seven reminders to take the survey.

Among respondents, 186 were internists, 146 were oncologists, and 146 were cardiologists. They were 65% male, and 38% had been in practice for 20 to 32 years. Around a third had received payments from drug, device, or other medical-related companies. Male respondents were more likely than females to report understanding the approval processes.

The study was limited by its sample, which did not represent all medical specialties. The survey did not ask about clinical practice setting or time spent in clinical practice, and researchers also cited the risk for nonresponse bias, because only 39% of physicians contacted responded. Regulatory events during the course of the study could have affected their findings, and social desirability bias could have also played a role, the authors acknowledged.

Comment