US FDA launches program to boost domestic drug manufacturing

By Ahmed Aboulenein

WASHINGTON, Feb 1 (Reuters) – The U.S. Food and Drug Administration on Sunday began accepting requests to participate in its PreCheck pilot program, designed to boost domestic drug supply by speeding up construction and review of drug manufacturing plants in the country.

The FDA said it would select an initial group of new pharmaceutical manufacturing facilities this year based on “alignment with national priorities” in several areas including the product itself, how quickly it can be developed for the U.S. market, and innovations in facility development.

“Additional priority considerations will be given to facilities producing critical medications for the U.S. market,” the agency said in a statement.

The FDA PreCheck program, first announced in August, aims to streamline review of domestic pharmaceutical plants and eliminate unnecessary regulatory requirements, in line with President Donald Trump’s executive order in May to shift manufacturing of drugs to the United States.

The program introduces a two-phase approach to facilitate new U.S. drug manufacturing facilities.

The initial phase would provide for more frequent communication with the FDA, including for facility design, construction and pre-production.

The second phase would facilitate pre-application meetings and early feedback to help streamline the development of manufacturing and quality control processes, the agency said.

The FDA had separately announced another program in June to incentivize drug developers that align with national priorities, including increased domestic manufacturing, with shortened times for reviewing marketing applications.

The FDA Commissioner’s National Priority Voucher Program promised decisions in one or two months on a limited number of drugs deemed critical to public health or national security, cutting four to six months off the fastest priority approval process.

Reuters, citing internal documents, reported exclusively last month that the agency had delayed reviews of two drugs chosen for the new fast-track program after agency scientists flagged safety and efficacy concerns, including the death of a patient while taking one of the medicines. 

Two other drugs tapped for the speedy review program have also been pushed by weeks or longer beyond the original target date. The four drugs are among at least seven in the program that have started their approval process, according to documents.

(Reporting by Ahmed Aboulenein; Editing by Sergio Non and Chizu Nomiyama )