The House Energy and Commerce Health Subcommittee, chaired by Rep. Joe Pitts (R-PA), today approved the Food and Drug Administration user fee package with strong bipartisan support on a voice vote. The legislation ensures continuation of various FDA programs, including the Prescription Drug User Fee Act and Medical Device User Fee Act, and authorizes new user fee programs, the Generic Drug User Fee Act and Biosimilars User Fee Act, to facilitate the review and approval of life-saving and life-improving drugs and medical devices. As part of the agreement, FDA will commit to certain performance goals, fostering more interaction, predictability, and certainty between industry and FDA. The legislation also includes reforms to ensure patients receive quality care and timely access to new therapies while promoting innovation and job creation. Click here to read a legislative summary.
Bipartisan FDA User Fee Bill Breezes Through House Panel
By Brett Norman
The FDA user fee bill was sent to the full House Energy and Commerce Committee Tuesday morning on a raft of blown kisses from Democrats and Republicans on the health subcommittee.
After more than a year of work, at least 10 hearings related to user fees, and “intense negotiations as recently as last weekend,” Chairman Joe Pitts (R-Pa.) said, the committee members praised their staffs and one another and passed the bill by unanimous voice vote. It took only about a half hourâ€¦
â€¦But the markup couldn’t have been more cordial, quite a contrast to the recent mood of the House. Waxman said development of this bill “should be a model for legislative action,” and heads nodded, all around.
FDA User-Fee Package Breezes Through House Subcommittee
By Margot Sanger-Katz
The package would renew agreements that fund FDA reviews of new drug and medical device applications. It also would create new, similar programs to fund reviews of generic drugs and so-called biosimilarsâ€”generic-like copies of biologic drugs, like blood products and vaccines. It would also make some alterations in how the agency reviews certain devices and provide financial incentives for drug companies to make new antibiotic drugs, among other provisionsâ€¦
Congress is Moving Quickly on FDA Bill
By Sam Baker
Congress is quickly moving ahead on a must-pass Food and Drug Administration bill, and so far, negotiators have been able to avert any major controversiesâ€¦
â€¦Steven Grossman, a regulatory consultant who writes a regular update called “FDA Matters,” said the negotiations have gone smoothly and lawmakers don’t seem dramatically far apart on most provisions.
“Right now I feel like they’re working pretty hard and staying within the channels of reasonable people disagreeing,” Grossman said.
The pharmaceutical industry’s leading trade group, the Pharmaceutical Research and Manufacturers of America (PhRMA), was still reviewing the Energy and Commerce proposals Monday, but a PhRMA official said the process has gone “really smoothly” so far.
Industry always pushes for a timely reauthorization, and the official said the pressures of election-year politics also helped build consensus for a quick, bipartisan process on the FDA bill.