FDA commits to success of the generic and biosimilar second-generation user fee acts Posted 14/04/2017

Representatives of the Centre for Drug Evaluation and Research (CDER), the Association of Accessible Medicines (AAM), the Biotechnology Innovation Organisation (BIO) and the Biosimilars Council Director reportedly testified on 8 March 2017 as to their commitment to the US Food and Drug Administration’s (FDA) recommendations for the second generation of user fee agreements covering both generics and biosimilars. 

FDA announced its recommendations for the second generation of user fee agreements covering both generics and biosimilars in mid-late 2016 [1, 2]. These have been set up to ensure that generics and biosimilars makers pay annual fees to FDA just as brand-name drugmakers do [3]. It is reported that they are intended to enable FDA to improve their structure and systems by increasing staff numbers, and establish a better managed biosimilar and generics review process to make these therapies available to patients sooner without compromising review quality [1]. As reported in their announcements they stated that there would be eight-month reviews of priority generics. The second-generation user fee acts are due to be implemented in late 2017 [3].

Now, CDER’s Janet Woodcock, reportedly testified before the House of Energy and Commerce health subcommittee that, to achieve their announced commitments, FDA plans to restructure its Office of Regulatory Affairs. This will begin in May 2017 and will ensure that groups of facility inspectors who only focus on pharmaceutical products are included. It was reported that representatives from AAM, BIO and the Biosimilars Council, also testified and agreed with the proposals.

As part of these commitments to the Generic Drug User Fee Act, GDUFA II, it has been reported that FDA plans to meet with companies prior to submissions of complex generic drug products [3]. At this time, they will clarify regulatory expectations with the aim of reducing the number of review cycles needed for approval to take place. They stated that they hope to reduce this from its current median of four cycles.

In their recommendations, the agency also committed to 10-month reviews of all abbreviated new drug applications (ANDAs). In light of this, they have worked to reduce the ANDA backlog, which is reported to have contained 4,700 applications in October 2012. Following review of FDA’s Office of Generic Drugs approved drug applications in February 2017, they announced that 61 applications were approved that month. This is an increase in generic drug approvals compared to previous months. They reported that many of the approvals were for applications in FDA’s ANDA backlog, and that they have now cleared the backlog of unreviewed applications. In July 2016, FDA announced that they were taking first review action on 90 per cent of the ANDAs and prior approval supplements in the backlog. However, the rate of first-cycle approvals is just 9%. As such, FDA noted that many applications would require more than a single round.

Related articles
Biosimilar User Fee Act reauthorization

Industry calls for generics user fees to be reduced

References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilar User Fee Act reauthorization [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Apr 14]. Available from: www.gabionline.net/Biosimilars/General/Biosimilar-User-Fee-Act-reauthorization
2. GaBI Online - Generics and Biosimilars Initiative. Generic and biosimilar user fee recommendations sent to Congress [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Apr 13]. Available from: www.gabionline.net/Generics/News/Generic-and-biosimilar-user-fee-recommendations-sent-to-Congress
3. GaBI Online - Generics and Biosimilars Initiative. FDA and industry agree on terms of GDUFA II reauthorization [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Apr 14]. Available from: www.gabionline.net/Policies-Legislation/FDA-and-industry-agree-on-terms-of-GDUFA-II-reauthorization

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