FDA to review the marketing of off-label use of medications to doctors


The U.S. Food and Drug Administration (FDA) is taking a step that could lead to new regulations governing the way pharmaceutical companies can put out off-label information about medications to physicians.

The FDA will hold two days of public hearings in November to receive feedback on just how companies should communicate with doctors about unapproved uses of drugs and medical devices. A notice of the November 9 and 10 hearings was published yesterday in the Federal Register.

The agency said it is undertaking a comprehensive review of its regulations and policies. While doctors can prescribe a medication for an unapproved use when in their judgement it is medically appropriate for an individual patient, drug manufacturers have been restricted in their ability to distribute information, such as reprints of medical studies, and have lobbied Congress and the FDA to loosen regulations, according to a report on STAT.


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But the FDA is concerned about companies disseminating information about an unapproved use of a drug that has not been proven safe and effective. Cases about pharmaceutical companies rights to distribute information about off-label use of their products have ended up in court.The upcoming meeting will be held at FDA offices in Silver Spring, Maryland, to allow the public to offer opinions and debate the issue.

In its notice, the FDA posed several questions including the impact on public health if increased marketing of products for off-label use is allowed and said input from the meetings would inform its future policy development.

Off-label prescribing is a common practice for physicians, particularly when treating some of their sickest patients for whom other remedies have failed, as FiercePracticeManagement has reported. But one study found the incidence of side effects also rises sharply when drugs are given to patients for other than their intended purposes.