FDA Publishes Blog On Modernizing Generic Drug Review Processes

February 8, 2016
Caroline Hroncich

Caroline Hroncich was associate editor for Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International from 2015 to 2017.

Stephen Ostroff published a blog on FDA regarding goals to modernize the generic drug review process in an effort to increase patient access to generics.

In response to the House Committee on Oversight and Government Reform’s Feb. 4, 2016 hearing to address the rise in prescription drug prices, Steven Ostroff, acting commissioner of food and drugs at FDA, published a blog for the agency citing the Generic Drug User Fee Amendments (GDUFA) as a potential method for increasing patient access to affordable generics.

FDA is working to approve generic drug applications “so when drug patents expire, less expensive generic options are available,” Ostroff said in the blog. Since August 2014, the agency has been able to make improvements to the generic drug approval process, including review of an 1100 abbreviated new drug application backlog. Ostroff said FDA “ended 2015 at a new monthly high of 99 generic drug approvals and tentative approvals in December.”

The rising cost of prescription drugs has become a topic of discussion after media outlets called attention to massive increases in drug prices. Turing Pharmaceuticals, a fledgling New York specialty biopharmaceutical company, gained attention after it bolstered the price of Daraprim (pyrimethamine) nearly 5000%, from $13.50 per pill to $750. Pharmaceutical giant Valeant was also challenged after the company raised the price of Nitropress (nitroprussid sodium) 212% and Isuprel (isoproterenol) 525%.

According to a report by the committee, 30 of the top selling drugs in the US have increased 76% between 2010 and 2014. Declining market competition plays an increasingly large role in bolstering profit margins for pharmaceutical companies. Older drugs like Daraprim, which is the only FDA-approved treatment for toxoplasmosis, monopolize the market, which may force patients to shell out large copays for prescriptions.

Ostroff says that while FDA is proud of its current work expediting the generic approval process, the agency will continue to improve GDUFA, in hopes of increasing output in the future. He says in the blog that the agency is currently “engaged in discussions with industry and public regarding the development of the second generation of GDUFA.” This updated version of GDUFA, titled GDUFA II, is scheduled to begin in 2017 and has the goal of bringing more “safe, effective, high quality, affordable generics to the market.” 

Source: FDA