HELP preparing skinny user fee bill

The Senate Health, Education, Labor and Pensions (HELP) Committee will meet May 10 to discuss and vote on legislation that will accompany reauthorization of FDA medical product user fees. HELP is expected to include very few new policies or missions in the bill, according to congressional staff, pharma industry lobbyists and patient advocates. HELP Chairman Lamar Alexander (R-Tenn.) has stated that he will only accept provisions that are non-controversial, bipartisan and related to medical products (see BioCentury, April 7).

HELP staff have been meeting with stakeholders over the last month to try to gain consensus on incentives for the development of generic drugs, the Research to Accelerate Cures and Equity (RACE) for Children Act (S. 456, H.R. 1231), and a federal right-to-try law. It is likely that incentives aimed at creating competition among generic drugs will be included in the final bill...