The Food and Drug Administration (FDA) unveiled a new plan to boost the nation’s domestic pharmaceutical supply.
“Our gradual overreliance on foreign drug manufacturing has created national security risks,” said FDA Commissioner Marty Makary. “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.”
According to the plan, the Facility Readiness Phase will provide manufacturers with “more frequent FDA communication at critical development stages, including facility design, construction, and pre-production.” The Application Submission Phase focuses on “streamlining development of the Chemistry, Manufacturing, and Controls section of the application through pre-application meetings and early feedback,” the FDA said.
The plan aligns with President Donald Trump’s executive order on providing relief to Americans and facilitating domestic pharmaceutical manufacturing. Trump’s order states that it is in the “best interest of the Nation to eliminate regulatory barriers to the domestic production of the medicines Americans need.” The order declares that the Trump administration “will work to make the United States the most competitive nation in the world for the manufacture of safe and effective pharmaceutical products.”
The plan comes as President Trump sent letters to seventeen drug manufacturers, listing steps that must be taken to reduce prescription drug prices. “Right now, brand name drug prices in the United States are up to three times higher on average than anywhere else for the identical medicines,” Trump’s letters say. “This unacceptable burden on hardworking American families ends with my Administration.”
