On Wednesday, the Senate Health, Education, Labor and Pensions Committee approved by voice vote legislation that would reauthorize and modify the Prescription Drug User Fee Act, The Hill's "Healthwatch" reports. The bill now heads to the full Senate.
The Senate bill would reauthorize user fees that drug and medical device makers pay to FDA to help the agency more quickly review their products. The measure also would:
- Add a new fee for generic drugmakers;
- Allow FDA to fast-track products for rare or serious diseases; and
- Strengthen record-keeping requirements for drugmakers (Baker, "Healthwatch," The Hill, 4/25).
The panel also approved a manager's amendment by Sens. Tom Harkin (D-Iowa) and Michael Enzi (R.-Wyo.) that would permanently reauthorize two programs aimed at encouraging drugmakers to perform pediatric studies on their products.
The manager's amendment also includes language that establishes an approval process for certain medical gases, as well as another provision that would require FDA to withdraw directives it gave to drugmakers regarding when the agency must be informed about changes to medical devices on the market (Khatami, CQ Today, 4/25).
Another provision by Sen. Orrin Hatch (R-Utah) would allow FDA to remove from circulation potentially dangerous imported drugs (McCarthy, National Journal, 4/25).
Reauthorization Legislation Stalls in House
Meanwhile, negotiations over similar legislation stalled in the House Energy and Commerce Committee on Wednesday, Politico reports.
Before the full Energy and Commerce Committee could begin marking up the legislation, committee Chair Fred Upton (R-Mich.) announced that the markup would be delayed until May 8.
Upton's announcement came after leaders of the House Energy and Commerce Health Subcommittee on Tuesday released a blueprint for the user-fee legislation that includes several provisions that are non-starters for Democrats, including one that would require FDA to weigh the economic effects of their regulatory decisions (Norman, Politico, 4/25).
Critics say the language would cause FDA product reviewers to stray from their traditional focus on determining drug safety and effectiveness. Democrats also disagree with provisions that would create incentives to develop new antibiotics, as well as a provision calling for new standards for approving medical devices (Reichard, CQ HealthBeat, 4/25).