FDA makes it easier to set up US manufacturing sites

The FDA has launched a programme to make it easier for drug companies to set up manufacturing facilities in the US and reduce the country's reliance on imported medicines.

Today, the regulator revealed FDA PreCheck, which introduces a two-phase approach to getting approval for new production sites, the first promising to provide quicker responses from the agency on start-up tasks like facility design, construction, and pre-production.

The second phase is based on a pledge by the FDA to 'streamline' the chemistry, manufacturing, and controls (CMC) section of new facility applications with the help of "pre-application meetings and early feedback."

The move ties in with President Donald Trump's ongoing campaign to drive medicines manufacturing to the US from overseas, a push that has already resulted in big investment commitments from a string of big pharma groups, including AstraZeneca, AbbVie, Roche, Novartis, Eli Lilly, and Johnson & Johnson.

Trump has relied on the threat of pharma tariffs on imports as a lever to encourage companies to reshore or onshore plants to the US, boosting domestic manufacturing, reducing imports, and creating new skilled jobs.

In May, Trump issued an executive order (number 14293) that specifically sought to address the length of time it takes to build or upgrade pharma manufacturing facilities in the US, put at between five and 10 years, which he blamed on a "myriad" of federal, state, and local requirements ranging from building standards and zoning restrictions to environmental protocols.

The order directed the FDA to streamline review of domestic pharmaceutical manufacturing and eliminate unnecessary regulatory requirements while maximising review timeliness and predictability.

"Our gradual overreliance on foreign drug manufacturing has created national security risks," said FDA Commissioner Marty Makary, who pointed to data showing that more than half of pharmaceuticals distributed in the US are manufactured overseas. The US is also heavily reliant on overseas sources for active pharmaceutical ingredients (APIs), with only 11% of them made by domestic producers.

"The FDA PreCheck initiative is one of many steps FDA is taking that can help reverse America's reliance on foreign drug manufacturing and ensure that Americans have a resilient, strong, and domestic drug supply," added Makary.

The new system encourages manufacturers to provide a comprehensive facility-specific information through a type V drug master file (DMF), a voluntary submission to FDA that may be used to provide confidential detailed information about facilities, processes, or equipment used in medicines production.

The FDA said that submissions might include site operations layout and description, pharmaceutical quality systems, and quality management maturity practices.

The agency is planning to hold a public meeting on 30th September to discuss the details of the FDA PreCheck framework.

Image by Pawel Szymczuk from Pixabay