FDA moves to increase competition among single-source generics

SILVER SPRING, Md. — Based on the latest update to the Center for Drug Evaluation and Research’s Manual of Policies and Procedures, the Food and Drug Administration is looking to create more competition among generics — particularly for generics made by a single manufacturer. 

 

The updated MAPP outlines situations in which abbreviated new drug applications (ANDAs) submitted by generics manufacturers will be eligible for an expedited review process, including submissions related to drug shortages, and legal requirements. Among them is the potential for expedited review for ANDAs related to what the agency calls “sole-source drugs" — drugs whose generic is manufactured by a single company. 

 

“Submissions for drug products for which there is only approved product listed in the Prescription Drug Product List…of FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations...and for which there are no blocking patents or exclusivities may receive expedited review,” the MAPP says, except for drugs that were approved under a certain provision of the Federal Food, Drug and Cosmetic Act.