2018: A year of Advancing Generic Products and Policies, Laying the Foundation for 2019

By: Scott Gottlieb, M.D., and Kathleen “Cook” Uhl, M.D.

Scott Gottlieb, M.D., is Commissioner of the U.S. Food and Drug Administration.

FDA-approved generic drugs account for 90 percent of the prescriptions dispensed in the United States and in 2018 alone, we approved or tentatively approved more than 1,000 generic drugs with record-breaking highs in Octoberand November. “First generics,” which are approvals for generic equivalents of branded drugs that previously had no FDA-approved generic, made up nearly 10 percent of 2018 approvals and about 14 percent were for “complex generic drugs,” or drugs that are particularly difficult to “genericize.”

But product actions alone don’t paint a complete picture of the FDA’s efforts to promote drug competition and patient access over the last year. We also advanced many policies aimed at making it more efficient to bring generic competition to the market starting with providing critical guidance and support to generic drug developers.

In 2018, we developed 245 new and revised product-specific guidances, which give applicants seeking to develop generic copies of brand-name drugs, a better opportunity to efficiently advance these products and prepare better, more complete application submissions. In addition, FDA released 73 product-specific guidances (and two draft guidances) related to transdermal and topical delivery systems, which are complex drug products applied to a patient’s skin. Because of the inherent complexity of delivering a drug through a transdermal or topical delivery system, making generic copies of these drugs can be challenging, and many brand-name transdermal and topical delivery system products have not faced generic competition, even when patents or brand exclusivities are no longer a hurdle to generic approval.

Kathleen “Cook” Uhl, served as Director of the Office of Generic Drugs, 2013 - 2019

We also implemented new statutory programs that Congress recently established to facilitate generic drug access, including a new designation — competitive generic therapy, which is intended to expedite the development and review of a generic drug for products lacking adequate competition. The FDA granted competitive generic therapy exclusivity (180-day exclusivity for certain first approved applications) for six generic drug products in 2018.

Other important advancements include implementation of a new mechanism, pre-Abbreviated New Drug Application (ANDA) meetings. These are meetings for developers, with a special focus on complex products — meetings that are helping to ensure patients have access to generic versions of the drugs they need. By removing barriers to generic drug development, the robust operation of the Generic Drug User Fee Act (GDUFA II), the pre-ANDA program is in full swing. As a result, we received 91 pre-ANDA meeting requests in 2018, more than triple the number of requests for similar meetings in the previous year.

Also, as part of FDA’s ongoing effort to modernize its interactions with industry, we created the CDER Direct NextGen Collaboration Portal (the Portal), which provides potential applicants a more efficient way to request pre-ANDA meetings. In 2018, we further enhanced the Portal to receive, manage, and track requests from generic drug manufacturers for information on a specific element of generic drug product development (controlled correspondence). We responded to a record number of controlled correspondence inquiries in 2018 and found that the Portal improved consistency, simplified acknowledgement, and facilitated triage and tracking for these important communications with potential applicants. These and other important activities reflect FDA’s commitment and success to getting these important medicines to the patients who need them.

The FDA’s 2018 Office of Generic Drugs annual report provides a comprehensive look at all we’ve accomplished in 2018 and illustrates how the agency is well-positioned to build upon this critical work in 2019.

2018 Generic Drug Approvals

2018 Generic Drugs Approved By Month Bar Graph

*A tentative approval does not allow the applicant to market the generic drug product and postpones the final approval until all patent/exclusivity issues have been resolved.

And as we look ahead at what we want to accomplish in 2019, we do so with a renewed commitment to making additional progress on many important fronts to ensure the American public has access to safe, affordable generic medicines including advancing additional policies to promote generic competition as well as our commitment to ensuring the medicines Americans take are safe and effective, which is at the core of our mission. Our progress on making approvals more efficient, and establishing new policy, has not and will not come at the expense of ensuring that both new generics and existing generics meet FDA’s gold standard for quality.

Scott Gottlieb, M.D., is Commissioner of the U.S. Food and Drug Administration

Kathleen “Cook” Uhl, served as Director of the Office of Generic Drugs, 2013 - 2019