Regulatory Focus™ > News Articles > FDA Office of Generics Points to Record-Setting 2016 Ahead of Next Week’s Hearing

FDA Office of Generics Points to Record-Setting 2016 Ahead of Next Week’s Hearing

Posted 24 February 2017 | By Zachary Brennan 

FDA Office of Generics Points to Record-Setting 2016 Ahead of Next Week’s Hearing

While reporting a US savings of $1.68 trillion over the last 10 years for generic drugs, Kathleen Uhl, director of the US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD), also unveiled statistics for another record-setting year in generic drug approvals.

Next Thursday, the House Energy & Commerce Committee will hold a hearing to discuss the reauthorization of generic and biosimilar user fee programs that help to fund the agency to speed approvals.

The new chairman of that committee, Rep. Greg Walden (R-OR) has said his committee will take up a bill from Reps. Kurt Schrader (D-OR) and Gus Bilirakis (R-FL) to further speed generic drugs to market and create a new priority review voucher (PRV) program for generics to incentivize development.

The meeting will also discuss the next iteration of the Generic Drug User Fee Act (GDUFA II), which supplements Congressional funding in exchange for more generic approvals on a faster timeline and priority reviews for certain generics, as well as the next iteration of the Biosimilar User Fee Act (BsUFA II), which will be crucial for FDA as it reviews a rising number of 351(k) applications.

OGD Report

In 2016, FDA’s OGD approved 73 first generic drugs (an alternative for a brand-name product where there was previously none), as well as a total of 630 abbreviated new drug applications (ANDAs) and tentatively approved 183, or 87 more than the record set in 2015 for the largest number approved in FDA history.

A revamped FDA staff communicated with industry through more than 4,800 information requests, more than 1,800 controlled correspondences, and more than 1,800 complete response letters detailing comments and questions that need to be addressed by the applicant.

In addition, OGD issued 158 new product specific guidances, many of which involved complex dosage forms, such as auto-injectors, inhalation powders, nasal sprays, topical products, and ophthalmic products, and revised 91 product-specific guidances. There are more than 1,500 product-specific guidances online.

FDA also awarded funding to 16 new external researchers to conduct regulatory science that will complement internal activities and OGD had 87 ongoing external research collaborations at the end of 2016.

Office of Generic Drugs Annual Report

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