FDA introduces measures to ease approval of complex generic drugs

FDA Commissioner Scott Gottlieb on Monday announced a number of initiatives designed to hasten the approval of complex generic drugs. "The new policies we're announcing today are aimed at ensuring that we provide as much scientific and regulatory clarity as possible with respect to complex generic drugs," Gottlieb stated.

The Commissioner noted that the FDA is issuing draft guidance to assist drugmakers in creating and submitting pre-abbreviated new drug application (ANDA) meeting requests to allow the agency to provide better advice to companies seeking to develop complex generic drugs. Gottlieb explained that the guidance will provide information regarding requesting and conducting product development meetings, pre-submission meetings and mid-review cycle meetings with the agency, noting that an analysis of the new drug programme revealed that earlier and more frequent meetings can reduce drug development times. 

Gottlieb also said that the FDA is issuing draft guidance to assist companies determine when ANDAs submissions for peptides would be appropriate. Gottlieb stated that the guidance applies to specific products, namely glucagon, liraglutide, nesiritide, teduglutide and teriparatide, which reference branded products manufactured using recombinant DNA technology. 

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Gottlieb noted that advances in technology for peptide synthesis and characterisation permit applicants to clarify that their products meet the "sameness" requirements for generic regulatory clearance. The Commissioner added that the new guidance will help confirm that the risk of an immune response from the generic drugs due to "differences in impurities will not differ from that of the reference drug."

Commenting on the news, WBB Securities president Steve Brozak remarked "this is a shot across the bow", adding "nothing in healthcare is instantaneous, but Gottlieb is starting to build a road map for how to prove a generic is equivalent to a complex brand-name drug."

Gottlieb has announced a number of initiatives since being confirmed to head the FDA in May. After stating that the agency should play a role in drug pricing, Gottlieb proposed several changes that would permit the FDA to influence drug pricing and increase generic competition. The Commissioner later suggested that the FDA might expedite certain generic drug applications to increase competition.

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