FDA Reform "Unlikely To Pass This Year"

Legislation to reform the US Food and Drug Administration will not happen this year, according to an attorney working with the Biotechnology Industry Organization on its agency reform proposals (Marketletter July 31). However, says Stephen Lawton of the law firm Hogan and Hartson, "there is a very real possibility" that it will pass in 1996, given "the enthusiasm on Capitol Hill of virtually everybody" for reform.

The BIO's proposal is being developed with the Pharmaceutical Research & Manufacturers of America, and covers only areas where the two are in full agreement, in order to speed passage. Mr Lawton said they hope to produce a three or four-title bill, with a portion each for drugs, biotechnology, medical devices (the PhRMA and BIO hold regular meetings with the Health Industry Manufacturers Association) and, perhaps, a general portion.

The BIO/PhRMA joint legislation is expected to include proposals on subjects such as privatization of FDA activities, and acceptance of products approved by the European Medicines Evaluation Agency and the UK Medicines Control Agency, but not on promotion and labeling of off-label drug uses, where there is still no agreement. According to Mr Lawton, this is an issue which is "basically going to be a war, and it's going to be resolved on Capitol Hill." Representative Ron Wyden's FDA Modernization Act (HR 1742: Marketletter June 26) would amend Section 201 of the Food, drug and Cosmetic Act's definitions of the words "advertising" and "labeling," in order to remove the FDA's power to approve promotional labeling prior to use or dissemination of drug products, and allow manufacturers to distribute scientifically-valid information on off-label uses of drugs and devices at professional meetings and to formulary committees. Such changes are necessary to foster sensible competition within the system, says Rep Wyden.