The U.S. government promulgated the Food and Drug Administration Reauthorization Act of 2017 (FDARA) in August 2017 after two years of negotiation, which authorizes FDA to continue to use the user fees of medical devices, pharmaceutical products, and other health products as its main source of fund and will continue in effect until 2022.
Sources of the budget for the U.S. pharmaceutical product review mainly include congressional appropriations and fees. The current user fee acts concerning pharmaceutical product review mainly include Prescription Drug User Fee Act (PDUFA), Medical Device User Fee Amendments (MDUFA), Generic Drug User Fee Amendments (GDUFA), and Biosimilar User Fee Act (BsUFA). For decades, user fees paid by the pharmaceutical products industry have provided necessary resources needed to conduct product reviews in a timely fashion and to help ensure the safety and effectiveness of pharmaceutical products that American patients depend upon; meanwhile, the user fee laws and corresponding performance goals and program enhancements have helped evolve the drug and device review process in the U.S., allowing patients access to new and innovative treatments as quickly as possible without compromising the FDA’s high standards.
Next, let’s learn about those user fee systems one by one:
PDUFA
The new drug application quantity increased year by year from 1970s, and the technical requirements for new drug application became increasingly higher, leading to the increase of data required to be submitted by pharmaceutical manufacturers, which increased the workload of the new drug review department of FDA and also prolonged the new drug review and approval time, resulting in the "drug lag". To effectively address this problem, after discussions and studies, the U.S. Congress promulgated the Prescription Drug User Fee Act (PDUFA) in 1992 that authorizes FDA to collect review fees from pharmaceutical manufacturers/applicants, to increase FDA’s source of fund for pharmaceutical product review, enable FDA to hire more reviewers and supporters, and update FDA’s IT system, and must be renewed and reauthorized every 5 years. Thereafter, the Congress reauthorized the PDUFA Ⅱ, Ⅲ, Ⅳ, Ⅴ, and Ⅵ, to continue the authorization till today. PDUFA has provided an important source of expenditure for FDA’s pharmaceutical product review, and achieved the balance between guarantee of safety, effectiveness, and quality of pharmaceutical products, and encouragement of innovation by accelerating pharmaceutical product review, over the more than 20 years since implementation.
List of Promulgation of PDUFA
|
PDUFA |
Approval date |
|
PDUFA Ⅰ |
October 29, 1992 |
|
PDUFA Ⅱ |
November 21, 1997 |
|
PDUFA Ⅲ |
June 12, 2002 |
|
PDUFA Ⅳ |
September 27, 2007 |
|
PDUFA Ⅴ |
July 9, 2012 |
|
PDUFA Ⅵ |
August 18, 2017 |
Generally, PDUFA fees are divided into three types: Application and Supplement Fee, Establishment Fee, and Product Fee, however, the PDUFA Ⅵ approved this year specifically includes Application Fee and Program Fee, with Product Fee adjusted, and the Supplement Fee and Establishment Fee canceled; under the new fee structure, 2...
(All Rights Reserved)