The US Food and Drug Administration has recommended three user fee programmes that are designed to help speed up the delivery of safe and effective drugs to patients.
Under the programmes, the industry can choose to pay fees to help fund a portion of the FDA’s drug review activities, while the FDA agrees to overall performance goals within a particular time frame. Recommended to Congress by Health and Human Services Secretary Kathleen Sebelius, the programmes include the fifth authorisation of the Prescription Drug User Fee Act (PDUFA), and new user fee programmes for human generic drugs and biosimilar biological products.
FDA Commissioner Margaret Hamburg said, "At a time of greater budgetary constraint, user fees provide a critical way for leveraging appropriated dollars, ensuring that FDA has the resources needed to conduct reviews in a timely fashion. Human drug user fees have revolutionised the drug review process in the US since they were adopted 20 years ago, allowing the FDA to speed the application review process without compromising the agency’s high standards."
It is hoped that fees paid by industry will speed up the review of critical prescription drugs and advance the development of drugs for rare diseases.
Caption: User fee programmes are designed to speed up the delivery of drugs to patients. Photo: Martin Allinger.
