FDA issues guidance to facilitate greater generic drug competition

The Food and Drug Administration Friday released draft guidance on how drug developers can apply for the agency’s Competitive Generic Therapies designation. Authorized by Congress in the FDA Reauthorization Act of 2017, the designation provides certain incentives for industry to develop generics for drugs lacking competition. FDA Commissioner Scott Gottlieb, M.D., said the agency also will advance additional policies over the next year to promote generic competition. “This will include the publication of a series of guidances to address regulatory and scientific challenges that make it generally more difficult to develop complex generics,” he said. “As part of this, we intend to issue draft guidance with recommendations on establishing active ingredient sameness. In addition, we’ll advance the development of new analytical tools and in vitro tests to provide additional accurate, sensitive and reproducible tools to support approval of complex generic drugs.”