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While the FDA’s recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) would cover the agency’s needs, Congress should consider appropriating more funds so the agency does not rely so much on user fees, PhRMA CEO Billy Tauzin said.
The two lead sponsors of legislation on improving the FDA’s drug safety efforts told the agency that, while they don’t like the idea of industry fees paying for agency reviews, the way these funds are used can be changed to balance the quick approval of drugs with increased safety monitoring throughout a product’s life cycle.
The U.S. Food and Drug Administration (FDA) is exempting drugs that will be used for the President’s Emergency Plan for AIDS Relief (PEPFAR) from Prescription Drug User Fee Act fees to lessen the financial difficulties associated with developing the products, agency guidance says.
The two lead sponsors of legislation on improving the FDA’s drug safety efforts told the agency that, while they don’t like the idea of industry fees paying for agency reviews, the way these funds are used can be changed to balance the quick approval of drugs with increased safety monitoring throughout a product’s life cycle.
The Senate Health, Education, Labor and Pensions committee will hold a hearing this week on industry user fees, continuing a series of congressional efforts to look into the FDA’s drug review process.
Astellas Pharma is moving to extend patent protection for its enlarged-prostate treatment Flomax, a blockbuster drug that generated more than $1 billion in sales last year, the company said.
Recommendations in the latest installment of the Prescription Drug User Fee Act (PDUFA) seek to bulk up the premarket drug approval process, stabilize financing and expedite drug development, FDA officials said at a recent public hearing.
The reintroduced “Access to Life-Saving Medicine Act,” a bill that would establish a clear and effective pathway for the FDA to approve generic copies of biologic drugs, may be attached to the Prescription Drug User Fee Act (PDUFA), congressional lawmakers said.