APCO assists 'off-label' push

WASHINGTON: APCO Worldwide is providing media relations support for a coalition of drug companies hoping to persuade the Food and Drug Administration (FDA) to permit distribution of peer-reviewed articles on "off-label" use of drugs to doctors.

WASHINGTON: APCO Worldwide is providing media relations support for a coalition of drug companies hoping to persuade the Food and Drug Administration (FDA) to permit distribution of peer-reviewed articles on "off-label" use of drugs to doctors.

The Medical Information Working Group (MIWG), which includes AstraZeneca and Pfizer, among others, argued in recent submitted comment to the FDA that distribution of "non-misleading, scientifically substantiated manufacturers' communications" benefits patients.

The MIWG sought media representation on the issue to avoid public confusion with current Congressional investigations into the marketing of drugs, like Lipitor, and the alleged delay in a release of a study discussing problems with cholesterol drug Vytorin, said the lead attorney for MIWG, Alan Bennett, managing partner for law firm Ropes & Gray's DC office.

"One would think this would be noncontroversial, but it gets confused with a whole set of issues," Bennett said.

APCO SVP Bill Pierce said outreach will be reactive, responding to trade or general interest media when inquiries are made.

The FDA has not stated when it will issue a decision on the matter.

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