FDA user fee reauthorization bill passes US House of Representatives Posted 11/08/2017

The US House of Representatives passed a bill on 12 July 2017 reauthorizing the US Food and Drug Administration’s (FDA) prescription drug, generic drug, biosimilar and medical device user fee programmes.

The user fee programmes are negotiated by FDA and pharma industry every five years and enable FDA to collect fees annually from drug and medical device makers. This funding is supplemental to what the US Congress appropriates to FDA each year and is intended to enable FDA to hire more staff, improve systems and establish a better managed review process to make therapies available to patients sooner without compromising review quality. The programmes have helped reduce backlogs at FDA, introduce innovative technologies and better engage patients. The current user fee programmes will expire on 30 September 2017 and the new versions will cover fiscal years 2018 to 2022.

Some amendments have been added since the last user fee authorization. Two amendments were added in the Senate hearing: Senator Hatch’s ‘expanded access amendment’ and Senators Collins and Franken’s ‘generic competition amendment’. The ‘generic competition amendment’, for example, allows for expedited review of priority generics [1].

With respect to biosimilars, FDA released a Biosimilar User Fee Act II (BsUFA II) performance goals letter, which outlined how the BsUFA II agreement would ‘help provide FDA with the resources needed to enhance the science-based review of new biosimilars, which will help increase competition in the marketplace to the benefit of patients’ [2].

The next step is for the Senate to pass the bill, however, despite the urgency, the Senate has not yet set forth its own timeline for voting on the bill.

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1. GaBI Online - Generics and Biosimilars Initiative. FDA to speed up review of priority generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Aug 11]. Available from: www.gabionline.net/Guidelines/FDA-to-speed-up-review-of-priority-generics
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilar User Fee Act reauthorization [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Aug 11]. Available from: www.gabionline.net/Biosimilars/General/Biosimilar-User-Fee-Act-reauthorization

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Source: Biocom,Whitehouse

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