US Congress Acts on Follow-On Biologics and FDA Funding

In late June and early July, the US Congress moved forward on three important bills affecting the biopharmaceutical industry, related to follow-on biologics, the Prescription Drug User Fee Act (PDUFA), and the 2008 FDA budget.

In late June, the Senate’s Health, Education, Labor, and Pensions (HELP) Committee voted in favor of the Biologics Price Competition and Innovation Act of 2007 (S. 1695), which will address the scientific, regulatory, and legal issues involved in bringing generic biologics to the marketplace. The bill will now move to the Senate floor.

On July 11, the House also voted overwhelmingly, by a vote of 403–16, to pass legislation reauthorizing the Prescription Drug User Fee Act (PDUFA) and enhancing the FDA’s drug safety programs. The bill, H.R. 2900, was debated under a suspension of rules, preventing the addition of any amendments to the legislation.

On July 19, the House and Senate Appropriations Committees each passed bills that would increase the FDA’s budget for fiscal 2008 by $128.5 million. The Senate version of the bill would increase FDA funding to $1.76 billion, where as the House version would provide the agency with $1.69 billion, an increase of approximately 11% and 8% over last year. Both bills will now move to the full chamber for consideration.