FDA launches pilot to speed up review for US generic drug manufacturing, testing

The Food and Drug Administration has launched a new pilot prioritization program intended to accelerate the review process for generic drug companies that test and manufacture their products in the United States.

The pilot is specifically designed for abbreviated new drug applications (ANDAs), which are generally not required to include preclinical and clinical data to establish safety and effectiveness. Instead, ANDA generic drug applicants must scientifically demonstrate that their product performs in the same manner as the innovator drug. 

Under the pilot, ANDA applicants who conduct any required bioequivalence testing in the U.S. and whose products are made using exclusively domestic sources for active pharmaceutical ingredients (APIs) are eligible for priority review.

“Overreliance on foreign drug manufacturing and testing creates risks both to national security and patient access, and undermines investments in U.S. research, manufacturing and production,” George Tidmarsh, director of FDA’s Center for Drug Evaluation and Research, said in a statement. “This pilot prioritization program can help ensure that Americans have a strong and resilient domestic drug supply.”

While generic medicines are the backbone of the U.S. drug market, making up approximately 90% of prescription volume, they represent a particularly vulnerable segment of the pharmaceutical supply chain. A recent analysis by US Pharmacopeia (USP) found that generics come primarily from India, while the U.S. produces only 12% of the APIs for medicines going to patients domestically.

Last week, the FDA held a public meeting at its White Oak campus in Silver Spring, Maryland and got generally positive feedback from industry stakeholders on its proposed new PreCheck program, designed to lower the regulatory burden on onshoring new pharmaceutical manufacturing facilities in the U.S.

PreCheck, which was launched in August, is part of the FDA’s response to President Donald Trump’s Executive Order 14293 which calls for regulatory relief to promote domestic production of critical medicines. The agency’s program takes a two-phase approach to help facilitate new U.S. drug manufacturing facilities.

At last week’s PreCheck meeting, Michael Brinkley, chief quality officer at U.S.-based generic pharmaceutical company PAI Pharma, noted that about 70% of generics and 75% of the APIs come from overseas. On the regulatory front, Brinkley asked that the FDA “look at ways of reducing the timeframes related to the ANDA process.” He said that “as drugs come off patent” and “go into the generics” it’s critical that generic drugmakers have a review process that is “more predictable on getting approvals for these drugs.”  

In announcing its new pilot program for ANDAs, the FDA said that it heard at last week’s PreCheck meeting from several industry stakeholders about how faster reviews could generate additional domestic investment. “This ANDA prioritization pilot represents a further step FDA is taking to incentivize U.S. generic drug manufacturing and testing,” according to the agency.