US PhRMA FDA Reform Bill Planned For May

The pharmaceutical Research & Manufacturers of America is seeking a legislative path to reform of the Food and Drug Administration, and to this end, it plans to have a bill ready to go to Congress in May.

Making this announcement at the PhRMA annual meeting at the end of March, association president Gerald Mossinghoff said that the goal is to enact legislation to achieve fundamental improvement in the FDA's approval of safe and effective drugs and biologics, and to ensure even-handed enforcement of regulations. He said the PhRMA was not yet ready to announce any final decisions regarding the legislation, but its Key Issue Team on FDA reform, which has had the assistance of three ex-FDA Commissioners, has agreed to general concepts regarding reform, and will now work to flesh these concepts out in much greater detail.

Association chairman Lodewijk de Vink, who is president and chief operating officer of Warner-Lambert, said the PhRMA is looking for a fundamental restructuring of the agency. Just as the industry must evolve new approaches, so must government policy make room for the innovations that serve the patient and, at the same time, make economic sense, he said.