Statement from FDA Commissioner Scott Gottlieb, M.D. responding to report from GAO and updating on FDA’s ongoing efforts to increase access to complex generic drugs

Today the U.S. Government Accountability Office (GAO) published a report titled “Generic Drugs: FDA Should Make Public Its Plans to Issue and Revise Guidance on Nonbiological Complex Drugs.” In preparing the report, GAO studied a number of issues related to the FDA’s review and approval of “nonbiological complex drugs.” The report contained a single recommendation for the FDA -- that the agency publicly announce its plans to issue or revise guidance for these drug products. We agree with GAO’s recommendation and the FDA is actively working to accomplish this goal through new policies that are already underway. One of the first actions I took when I arrived at the FDA was announcing our Drug Competition Action Plan. This comprehensive plan was aimed at promoting competition and access, especially when it came to the development of generic drugs in pharmaceutical categories that lacked competition. Continue reading...