Magazine article Drug Topics

Off-Label, Off-Base

Magazine article Drug Topics

Off-Label, Off-Base

Article excerpt

Physicians are getting unapproved-use data from manufacturers that is denied to pharmacists

Information from a pharmaceutical manufacturer on an off-label drug use may already be showing up in physician's offices. Last month, the Food & Drug Administration told the first five companies-which it declined to name-that it had completed a 60-day review of the reprints of peer-reviewed journal articles or published reference material that they submitted and want to distribute.

Until ordered by Congress to lighten up, the FDA had long forbidden manufacturers from disseminating unsolicited data on unapproved uses to anyone. Under the 1997 FDA reform law and a final FDA rule just taking effect, drugmakers now can disseminate certain off-label-use data about approved products. They first have to let the FDA examine the material-such as studies they had no influence over on the safety, efficacy, or benefits of an off-label use-for 60 days. They also have to pledge to submit a supplemental New Drug Application for the off-label use.

But neither pharmacists nor patients qualify to receive the data. "It is essential that this information be provided only to persons who have the education, training, and experience to interpret its meaning and relevance," said the FDA when it first proposed its rule on dissemination of information on off-label use. According to the FDA, that covers prescribers, pharmacy benefit managers, health insurance issuers, or group health plans, but not pharmacists.

Pharmacy fought a losing battle with the FDA to gain access to the information. "Pharmacists receive extensive in-depth training in pharmacology, kinetics, dosage estimates, drug interactions, available products, and drug therapy management," Judith A. Cahill, executive director of the Academy of Managed Care Pharmacy, told the FDA. "This training in appropriate medication use makes the pharmacist uniquely qualified to interpret the meaning and relevance of this information. …

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