On Friday, January 13, Health and Human Services Secretary Kathleen Sebelius transmitted FDA’s recommendations to Congress for the fifth reauthorization of the Prescription Drug User Fee Act (PDUFA) and for new user fee programs for generic drugs and biosimilar products.
Under a user fee program, industry agrees to pay fees to help fund a portion of FDA’s drug review activities and in return FDA agrees to certain performance goals, including tighter review timelines.
The new user fee proposals are the result of numerous public meetings between FDA and various stakeholders on their content, cost and impact.
In December, the last of five public meetings on the Generic Drug User Fee Amendments (GDUFA) was held at FDA’s White Oak, Maryland headquarters (IPQ “In the News” December 29, 2011).
Also in December, FDA held a public meeting on its proposal for user fees for biosimilars (IPQ “In the News” December 28, 2011). Before the meeting, a draft of its biosimilar performance goals was released for public comment. As in its GDUFA, FDA asked for comments to be submitted by January 6 to allow it to meet the tight timeline for getting the proposal to Congress.
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