FDA pilot program creates new avenues for faster generic drug reviews
Big pharmaceutical companies are increasing the production capacity of their branded pharmaceutical products, including billions of dollars in construction of new manufacturing plants, but general pharmaceutical production is still mostly overseas. The FDA addresses this imbalance through a new pilot program that incentivizes domestic manufacturing of generic drugs by speeding up regulatory scrutiny of these drugs.
Eligible drugmakers must purchase ingredients and manufacture medicines made within the U.S. border, under a new pilot program announced Friday. These demands are consistent with other initiatives introduced by the Trump administration, part of a broader strategy to reshape pharmaceutical manufacturing.
More than half of the drugs distributed in the United States are produced overseas, the FDA said. Even when the drugs are produced in the United States, the finished product often uses active pharmaceutical ingredients (APIs) from overseas. According to the number of institutions, only 9% of API manufacturers are in the US, while 22% are in China, while 44% are in India.
The FDA reviewed generic drugs under the abbreviated New Drug Application (ANDA) pathway. Typically, drugs performed through this pathway must be clinically tested to demonstrate bioequivalence to the reference product (a drug that has been approved by the FDA). Most clinical testing of generic drug candidates is conducted outside the United States, which the FDA believes will weaken the U.S. drug and R&D infrastructure.
To obtain a new pilot program, drugmakers must also perform any necessary bioequivalence tests in the United States, which must be produced in the United States using exclusive domestic API sources. Drugs that show that these requirements must be included in the company's request to seek this new type of priority FDA review.
“The excessive reliance on foreign drug manufacturing and testing poses risks for national security and patient visits, and undermines investment in research, manufacturing and production in the United States,” said George Tidmarsh, director of the FDA Center for Drug Evaluation and Research. “This also slows down the review and makes taxpayers more money because these foreign research and testing sites have to be inspected by the FDA, and foreign inspections take more time to prepare and are more expensive than domestic inspections.”
The agency has not quantified how many faster generic drugs will be reviewed under the new pilot program. But domestic production is a key component of another FDA pilot program focused on branded products. The program was unveiled in June and can qualify certain brands of drugs for a shorter regulatory review as long as qualified products are in the health interests of certain countries, such as addressing national security and health crises or increasing domestic production in terms of national security. Drugs eligible for the program will be awarded a national priority review certificate from the Commissioner, which will shorten regulatory review to two months.
Big pharmaceutical companies have been increasing U.S. manufacturing capabilities to avoid the president’s threat to impose potential drug tariffs on imported drugs. Trump said in a social media post in late September that no generic drugs were mentioned in the postal unless the manufacturer of the product broke the ground or built a pharmaceutical factory in the United States, suggesting that the products would be tax-free.
Trump has taken other steps to strengthen domestic drug production. The May executive order directed the FDA to evaluate existing regulations with the aim of simplifying review and licensing of new domestic drug manufacturing facilities. In August, the FDA launched Precheck, a program that provides more frequent communication during the development phase of the new facility and simplifies the chemical, manufacturing and control measures section of the application to build new facilities and use pre-applied meetings and early feedback. Last week, the FDA held a public meeting to discuss the new Precheck plan.
Domestic API production is a key component of another executive order. The August order directed the Department of Health and Human Services to compile a list of key medicines. The government will then store APIs for the drugs, which the order says will quarantine the U.S. from foreign concentration in the supply chain, while also encouraging more domestic API production.
Photo: Stuart Ritchie, Getty Images
