Survey Suggests Disconnect Between What Physicians Expect When New Drugs Are Approved, And What FDA Actually Requires

"It matters because physicians use prescribed drugs on the presumption they have been adequately tested and rely on FDA approval," said Dr. Aaron Kesselheim, a co-author of the research. "They feel comfortable that a group of independent experts have reviewed the data, but it’s a problem because physicians are relying on their perception of what FDA approved actually means,”

Stat: Many Doctors Uncertain About FDA Approvals — And Dislike Off-Label Marketing

In the wake of debate over regulatory approval standards for medicines, a new survey finds that most physicians favorably view the approaches taken by the Food and Drug Administration, but a key “disconnect” also exists between their perceptions and the reality of the approval process. Of nearly 700 respondents, 80 percent agreed that the FDA process helps “protect the public from ineffective or dangerous drugs.” And 65 percent reported they were satisfied with the standards used by the FDA to approve medicines, while only 24 percent indicated approval standards are too high, according to a research letter in JAMA Internal Medicine. (Silverman, 1/30)

In other news on the FDA —

The Associated Press: FDA OKs 1st Generic Version Of Popular Advair Asthma Inhaler

The first generic version of the popular Advair asthma inhaler has been approved by U.S. regulators. The Food and Drug Administration on Wednesday approved Mylan's version in three strengths for ages 4 and up. The inhalers are used twice daily to keep airways open and prevent flare-ups of wheezing, shortness of breath and other symptoms of asthma or chronic obstructive pulmonary disease. About 42 million Americans have those conditions. (Johnson, 1/30)

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