The Pharmaceutical Research and Manufacturers of America (PhRMA) is expected to unveil its legislative agenda formally at a press conference this week, but drafts of its FDA reform bill have been floating around Washington for weeks.

The draft bill is an amalgam of last year's Senate and House bills. Provisions include: imposing performance standards on the agency; changing the statutory basis for regulating biologicals to achieve uniform regulation of drugs and biologicals; allowing the submission of summary data for NDAs; giving FDA authority to use third party reviewers for NDAs and supplemental NDAs; and imposition of strict deadlines for scheduling and meetings with sponsors.