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Biotech / Medical : Pharma News Only (pfe,mrk,wla, sgp, ahp, bmy, lly)

PFE 25.74

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Nov 28 9:30 AM EST

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To: James Baker who wrote (230)	6/7/1998 12:11:00 PM
From: Anthony Wong	Read Replies (1) of 1722

FDA Issues Proposal for 'Off-Label' Advertising of Products Bloomberg News June 5, 1998, 12:59 p.m. PT FDA Issues Proposal for 'Off-Label' Advertising of Products Washington, June 5 (Bloomberg) -- Companies will be able to tell doctors, insurers and government agencies about unapproved uses or benefits of drugs or medical devices already on the market, under a new U.S. Food and Drug Administration proposal. Under the new regulation, companies could distribute certain information to health professions -- such as a medical journal article -- as long as they abide by set of rules. Among other things, companies must inform the FDA ahead of time, ensure the product doesn't pose ''a significant risk'' to patients and agree to submit an application for the new claim within three years among other things, the agency said. The proposal on so-called off-label uses of products is one of several regulations the FDA is required to draft under an agency overhaul act passed by Congress last year. In the past, the FDA refused to allow companies to advertise unapproved claims about an approved product to doctors, saying that would eliminate an incentive to prove the claim with research. The FDA overhaul law ''and the new proposed rules tie dissemination of this information to a commitment to do the necessary research on the new uses,'' said William Schultz, the FDA's deputy commissioner for policy. One potential beneficiary of the new regulation would be Eli Lilly & Co. The Indianapolis-based drugmaker is studying its Evista osteoporosis prevention drug for use in preventing and treating cancer. Under the new rules, the company could distribute preliminary studies to doctors showing the drug's benefits in cancer as it prepares its application for formal FDA approval of that use. The proposal is open for comment for 45 days, the FDA said. A final rule is supposed to be in place by Nov. 21, one year after the FDA overhaul bill's enactment, the agency said. --Kristin Jensen in the Washington newsroom (202) 624-1843 /mfr

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