FDA welcomes alternative approaches to generic drug development

Issuance of a product specific guidance should not “diminish innovation or creativity” in generic drug development, Robert Lionberger, director for the office of research and standards in the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Office of Generic Drugs, said at a 5 May webinar on the development of product specific guidance.

FDA officials said that the number of a product specific guidances (PSGs) issued by the Office of Generic Drugs (OGD) has increased steadily since FY 2013. Lei Zhang, the deputy director for the office of research and standards in OGD, said that in FY 2020, FDA issued a record high number of new and revised PSGs totaling 258. In FY 2019, 252 were issued, as were 208 in FY 2018.

FDA issued a grand total of 1,558 PSGs from FY 2013 to FY 2020. Most of these, or 918 (59%) were for non-complex formulations while 640 (41%) were for complex products, Zhang said.

The FDA receives between 150 and 200 requests every year for a PSG.

According to Christine Le, PSG program manager, changes to the reference product must occur for a PSG to be revised. Changes could include a labeling update or a supplement, a new strength, or newly identified safety concerns. Updates may also be prompted by a citizen petition or new approaches for demonstrating bioequivlance.

The existence of a PSG for a particular product is meant to “light the path” for generic drug development for a particular formulation but is not meant to discourage alternative approaches, Lionberger said. “The guidelines are recommendations, but they are not meant to preclude innovation.”

Lionberger also noted that generic drug makers often are concerned that a PSG revision will introduce major changes. That this is rarely the case, he said. “There are very few major revisions in the PSG program.”

He added that in the current system, “there is not much of a difference between a draft and a final guidance, it is mainly an administrative action, but for right now, there are no substantive differences.”

Further, there is no way to search the FDA’s database for previous drafts of PDGs as only the final versions are available, according to Le.

FDA webinar on product specific guidance for generic drugs

FDA welcomes alternative approaches to generic drug development

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