Office of Generics

FDA’s Office of Generics sets a record of 800+ approvals in 2016

Timely delivery of results will help in GDUFA renewal come October


If there’s one thing that FDA gets routinely pilloried over, it’s the backlog of approved generics available to enter the US market. Especially when a drug has lost its patent exclusivity, yet is still single-sourced, Congress, healthcare commentators and FDA critics in general pile on the agency, even though FDA cannot of its self cause alternative sources to be available. So, its just-released summary of 2016 actions, with 630 fully approved Abbreviated New Drug Applications (ANDAs), and 183 tentative approvals (cleared scientifically but awaiting patent decisions) is good news for the agency and for US healthcare generally. This record exceeds last year (also a recordbreaker) by 87.

Equally important, for some drugs at least, is product-specific guidances, which are documents covering complex dosage forms “such as auto-injectors, inhalation powders, nasal sprays, topical products, and ophthalmic products,” according to FDA; 158 of these were issued.

Say goodbye to some well-known brands that have lost patent exclusivity in 2016: Tikosyn, Nasonex, Benicar, Tamiflu, Crestor and Viagra; altogether, there were 73 first generics approved in the year.

The capability for FDA to accelerate its generics review program is highly dependent on the Generic Drug User Fee Act (GDUFA), passed in 2012 and up for renewal this year. FDA made a commitment to have more timely reviews started if not completed. It hired an additiona l125 reviewers during 2016; however, additional hiring is now being held up by the Trump Adminstration decision to freeze federal employment. FDA also notes that its ability to conduct reviews and issue approvals is helped by expanded local efforts and better coordination with manufacturers in India, China and Latin America.