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

Kathleen Uhl, director of the United States Food and Drug Administration's Office of Generic Drugs (OGD), also unveiled another record year for generic drug approval.

Next Thursday, the House Energy and Commerce Committee will hold a hearing to discuss the reauthorization of generic and biosimilars user payment programs that help fund the agency to accelerate approvals.

The new chair of this commission, Rep. Greg Walden (R-OR), said his committee will take representatives. Kurt Schrader (D-OR) and Gus Bilirakis (R-FL) to accelerate generic drugs in the market and create a new Priority Review Program (PRV) bonus for generic drugs to promote development.

The meeting will also discuss the upcoming iteration of the Generic Drug Use Fee Act (GDUFA II), which complements Congressional funding in exchange for more generic approvals at a faster schedule and prioritized revisions for certain generic and Next iteration of Biosimilar User Rates Act (BsUFA II), which will be crucial for the FDA as it reviews an increasing number of 351 (k) applications.

EMT Report

In 2016, OCD FDA approved 73 generic first (an alternative to a branded product, where there were none before) and a total of 630 New Drug Abreast (ANDA) applications and provisionally approved 183 or 87 record set in 2015 for the Number approved in the history of the FDA.

A new FDA staff in contact with the industry, with more than 4800 requests for information, more than 1800 matches and controls more than 1800 complete response letters detailing the comments and questions that must be addressed by the applicant.

In addition, EMT 158 issued new product guidelines, many of which had complex dosage forms, such as auto-injectors, inhalation powders, nasal sprays, topical products and ophthalmic products. There are more than 1,500 in the line guidelines.

The FDA also provided funding to 16 new outside researchers to conduct regulatory science activities that complement the business, and OGD has conducted 87 ongoing external research collaborations, by the end of 2016.