FDA Pilot Program Creates New Path for Faster Regulatory Review of Generic Drugs - MedCity News

"Big pharmaceutical companies are boosting their production capacity of branded pharmaceutical products with billions of dollars in new U.S. manufacturing plant construction, but generic drug production still remains mostly overseas. The FDA is addressing this imbalance through a new pilot program that incentivizes domestic manufacturing of generic drugs by speeding up the regulatory review of these medicines. Under the new pilot program announced Friday, eligible drugmakers must source the ingredients and make the finished drug product within U.S. borders."

"More than half of pharmaceuticals distributed in the U.S. are manufactured overseas, the FDA said. Even when drugs are made in the U.S., the finished product often uses an active pharmaceutical ingredient (API) from overseas. By the agency's count, just 9% of API manufacturers are in the U.S. while 22% are in China and 44% are in India. The FDA reviews generic drugs under the abbreviated new drug application (ANDA) pathway."

"To qualify for the new pilot program, a drugmaker must conduct any required bioequivalence testing in the U.S. Also, the product must be made in the U.S. using exclusively domestic API sources. Documentation showing a drug meets these requirements must be included in a company's request seeking this new type of priority FDA 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"

Major pharmaceutical firms are increasing U.S. capacity for branded drugs while generic drug production and active pharmaceutical ingredient (API) manufacturing remain concentrated overseas. The FDA launched a pilot program to accelerate regulatory review for generics that are sourced, tested, and manufactured entirely in the United States. Eligible drugmakers must perform bioequivalence testing in the U.S., use exclusively domestic API sources, and include documentation proving compliance when requesting priority review. The FDA reports that more than half of drugs distributed in the U.S. are made abroad and that only 9% of API manufacturers are domestic.

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