Docs Don’t Understand FDA Approval Process: Research

Many doctors are not familiar with how FDA regulates new drugs and medical devices, according to the results of a survey conducted by researchers at the University of California San Francisco (UCSF). The researchers say that doctors may be under the impression that the data supporting drug and medical device approvals are more rigorous than they are.

Writing in Health Affairs, the researchers report (purchase required) that doctors said they wanted to see more rigorous pre-market evidence and regulatory action against products that don’t demonstrate safety and effectiveness after they have been approved for use.

“Many of the physicians we queried felt that FDA has become more lenient over time,” said UCSF cardiologist Sanket Dhruva, an assistant professor of medicine and the article’s lead author. “Physicians need, and want, to know if a drug or device was rigorously studied before they can make recommendations to their patients.”

The national survey involved 509 randomly selected internists, oncologists, and cardiologists. It covered physicians’ perception of FDA approval, characteristics that physicians think are important among studies supporting agency approval, views about expedited FDA development or review, and views about moderate-risk device approvals.

Nearly all respondents thought that randomized, blinded trials that met primary endpoints should be very important factors required to secure regulatory approval, with majorities saying that FDA should require two or more randomized controlled trials of most new drugs (57%) and for most new devices (60%). Nearly all respondents thought FDA should revoke approval for drugs in the accelerated approval program (95%) or breakthrough devices program (89%) that do not show benefit in post-approval studies.

“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,” Dhruva commented. “Despite these preferences, the proportion of studies leading to FDA approval that feature these characteristics has fallen in recent years.”

The authors say that the prevalence of doctors reporting a lack of understanding of drug and medical device approval reflects the limited coverage of these topics during medical education. They also say FDA could explain clearly and concisely how and why a drug was authorized, including the key rationale in its risk/benefit assessment and what knowledge gaps remain.