FDA to pilot faster review of generic drugs manufactured in the US
Sets bioequivalence and active pharmaceutical ingredient (API) requirements for its new ANDA prioritisation programme.
Generic drugs that are tested and manufactured in the US for American consumers will be eligible for a new pilot programme that prioritises their review.
The Food and Drug Administration’s abbreviated new drug applications (ANDAs) scheme is the latest incentive to encourage the pharma industry to move its manufacturing investments to the US.
It’s open to pharma companies that conduct bioequivalence testing in the US and whose product is made in the US using exclusively domestic sources for active pharmaceutical ingredients (APIs).
Those that can show that their finished dosage form manufacturing takes place in the US and that their API supplier is also located in the country will be eligible for priority review for that product.
In addition to rewarding US manufacturing and R&D investments the programme also aims to strengthen the country’s domestic pharma supply chain. Currently the FDA says more than half of the pharmaceuticals distributed in the US are manufactured oversees, with just nine percent of APIs made in the country.
Dr George Tidmarsh, Director of FDA’s Center for Drug Evaluation and Research, said: “Overreliance on foreign drug manufacturing and testing creates risks both to national security and patient access, and undermines investments in US research, manufacturing and production.
“It also slows down reviews and costs taxpayers more money, as these foreign research and testing sites must be inspected by FDA, and foreign inspections take more time to prepare for and are more expensive to conduct than domestic inspections. This pilot prioritisation program can help ensure that Americans have a strong and resilient domestic drug supply.”
The scheme builds on the FDA PreCheck programme, which was announced in August to provide more support and a streamlined application process to pharma companies constructing new US facilities.
Companies wanting to benefit from the ANDA prioritisation programme will need to follow the procedures outlined in FDA’s Manual of Policies and Procedures (MAPP) 5240.3, Prioritization of the Review of Original ANDAs, Amendments, and Supplements (“Prioritization MAPP”), referencing the pilot program as the basis for prioritisation.
