AMCP pleased with revised PDUFA

The Academy of Managed Care Pharmacy (AMCP) strongly favors the revisions of the Prescription Drug User Fee Act (PDUFA) that the US House of Representatives and the US Senate conference committee negotiated earlier this week and the House passed by voice vote on Wednesday.

This legislation reauthorizes drug and medical-device user-fee programs for 5 years and establishes new user fees for FDA’s review of generic drugs and biosimilar agents. The measure will return to the Senate for approval.

Among the provisions outlined in the bill, the AMCP supports changes that would promote the development and use of safe and effective biosimilar therapies and generic drugs and eliminate barriers to these products coming to market. The AMCP also is pleased with the provision that manufacturers provide early notice to FDA about drug shortages, according to AMCP’s press release.

“AMCP is supportive of the establishment of a biosimilar and generic user fee within PDUFA reauthorization. We believe funding is imperative not only to support the biosimilar and generic review programs but also to support effective postmarket risk management,” said AMCP CEO Edith A. Rosato, RPh, IOM, in a statement.

The biosimilar user-fee provision will help to address the need to bring lower cost but equally effective biological therapies to the US marketplace. “Consumers, health plans, and other payers can eventually look forward to significant savings with these life-saving products that are becoming more prevalent in today’s healthcare marketplace,” Rosato continued.

The AMCP is concerned that certain provisions were not included in the reauthorized legislation, such as stringent postmarket risk management requirements and efforts to review direct-to-consumer (DTC) marketing. “The Academy supports measures to strengthen the FDA’s postmarketing safety and DTC advertising efforts, and urges Congress to continue to work together to enhance these programs for the benefit of future patients and healthcare providers,” Rosato said.