Generic Drug Approvals Hit New Record in 2015, FDA Report Shows

Regulatory NewsRegulatory News | 13 April 2016

The US Food and Drug Administration (FDA) approved more generic drugs in 2015 than ever before and is on track to meet all of its goals from the Generic Drug User Fee Act of 2012 (GDUFA) by 2017, according to the first annual report from FDA’s Office of Generic Drugs (OGD).

More than 700 generic drugs were approved and tentatively approved in 2015, which was the highest figure ever; and in December, FDA granted the highest number of approvals and tentative approvals in a single month (99) since the generic drug program began, according to the new report, which echoed FDA’s performance report to Congress from late March.

The approvals are an important way in which FDA is able to keep the cost of drugs in check, particularly as generic drugs now account for 88% of prescriptions dispensed in the US, and they have saved the US health system $1.68 trillion from 2005 to 2014.

The success of OGD is thanks in a large part to GDUFA, under which industry agreed to pay approximately $300 million in fees each year of the five-year program, which is set to end in 2017. Negotiations for the next GDUFA agreement between FDA and industry are ongoing and will focus particularly on FDA’s performance goals.



One of the major concerns of Congress is that not too long ago the backlog of abbreviated new drug applications (ANDAs) waiting for FDA action was mounting. And FDA acknowledges that as of 1 October 2012, the backlog included 2,866 ANDAs and 1,873 prior approval supplements (PASs).

But since then, and after a major restructuring of OGD and the hiring of hundreds of new employees, FDA completed first actions on 84% of ANDAs and 88% of PASs by 31 December 2015.


In addition, the filing backlog for ANDAs (filing is the process by which FDA evaluates if a drug applicant’s submitted application is sufficiently complete to permit FDA’s review) has been nearly eliminated and filing is performed now in real time. That compares with the daunting stack of 1,100 applications that had not yet been reviewed for an initial filing decision back in August 2014.

For ANDAs submitted in FY 2015 that had GDUFA goal dates, OGD issued filing decisions within 60 days for 99%, and, on average, filing decisions are made and communicated to industry in approximately 40 days.

Meanwhile, as far as controlled correspondence (commonly referred to as “controls”), which are product development questions that FDA answers to help companies develop ANDAs, FDA had a backlog of controlled correspondence submitted before October 2014, which the agency has now essentially eliminated. In 2015, in fact, OGD closed out 2,065 controls, a record number.

The progress of OGD has in part been the result of a critical improvement to the ANDA review process - assigning a regulatory project manager (RPM) to each ANDA, which first started in 2014. This change offers industry a central point of contact for each ANDA within OGD, which is continuing to look for ways to provide more clarity and predictability to the ANDA review process.

New Guidance

OGD also began issuing product-specific recommendations to facilitate efficient ANDA filing review, premarket development of generic drugs and accurate tracking of OGD’s activities.

In deciding which guidance documents to issue, OGD considers the complexity of the formulation, ability to accurately measure its bioavailability at the site of action, scientific methods to demonstrate bioequivalence and previous experience with and knowledge of similar drugs. OGD also takes into consideration the level of demand for such guidance, which is assessed through incoming requests and by analyzing the list of 100 top-selling drugs and other broadly used drugs.

OGD Director Kathleen Uhl, MD, wrote in a blog post Wednesday: “As part of our effort to align with stakeholders’ visions, we’re holding a public meeting on May 20 to solicit valuable feedback on our regulatory science initiatives and help us chart directions forward. We invite all to attend and to contribute by providing your thoughts and ideas to our public docket.”

The agency this week also unveiled the types of grant projects it would fund for FY 2016, including research on aberrant observations and their impact on bioequivalence assessment, as well as generic drug substitution in special populations.

Office of Generic Drugs (OGD) Annual Report for 2015

FY2016 GDUFA Regulatory Science Funding Announcements

2015: An Important Year for Advancing Generic Drugs at FDA by Dr. Uhl


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