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# Doctors’ Concerns About FDA Approvals, Off-Label Marketing
- URL: https://www.fdaweb.com/doctors-concerns-about-fda-approvals-off-label-marketing/
- Published: 2019-01-29T12:00:00.000Z
- Updated: 2026-09-15T00:58:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143248

A *JAMA Internal Medicine* Research Letter by researchers from Harvard Medical School and elsewhere [says](https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2720752?ref=fdaweb.com) that most of 686 respondents surveyed favor a relatively high bar for FDA approval of new drugs and prefer restrictions on off-label marketing. The survey was conducted to gauge the attitudes of internists, endocrinologists, and cardiologists toward FDA’s greater use of expedited development and approval pathways that place greater reliance on postmarketing drug data, and toward court decisions and state and federal legislation easing restrictions on off-label advertising.

“Since FDA approves about one-third of new drugs on the basis of a single randomized trial and often relies on results from nonrandomized studies,” the researchers wrote, “we thus observed a disconnect between many physicians’ perceptions of the drug approval process and its current reality. Physicians’ views on the dangers of widespread off-label marketing undercut judges’ rationale for permitting off-label marketing; for example, the majority decision in one notable case did not recognize that off-label marketing statements, even if not fraudulent, may still fall well short of accurate, unbiased information.”