FDA Unveils New Program to Boost Domestic Production of Medications

The FDA indicated that the new PreCheck Program will be rolled out in two phases.

The Food and Drug Administration campus in Silver Spring, Md. Andrew Harnik/AP Photo

The Food and Drug Administration (FDA) announced on Aug. 7 its new PreCheck Program, designed to increase the United States’ drug supply by simplifying requirements for establishing new U.S. drug-manufacturing facilities.

According to an FDA statement, more than half of the pharmaceuticals distributed in the United States are manufactured abroad. The United States has also relied on foreign sources for many active pharmaceutical ingredients (APIs), with only 11 percent of the manufacturers currently producing FDA-approved APIs located within the country.

“Our gradual over-reliance on foreign drug manufacturing has created national security risks,” FDA Commissioner Dr. Marty Makary said in the statement.

“The FDA PreCheck initiative is one of many steps the 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.”

The new program came in response to the “Regulatory Relief to Promote Domestic Production of Critical Medicines” executive order issued by President Donald Trump. It directs the FDA to simplify the review process for domestic pharmaceutical manufacturing and eliminate unnecessary regulations.

The FDA indicated that the new PreCheck Program will be rolled out in two phases. Phase One, the Facility Readiness Phase, will provide more communication between the FDA and drug manufacturers during critical development stages, including facility design, construction, and pre-production.

During this phase, pharmaceutical firms can also provide the FDA with specific information about the facility through a Type V Drug Master File.  This can also include data on site operations, layout, and drug descriptions, as well as “Pharmaceutical Quality Systems” information and “Quality Management Maturity” practices.

Phase Two, the Application Submission Phase, will concentrate on streamlining the development of the chemistry, manufacturing, and controls of the application with pre-application meetings and early feedback.

In the meantime, Trump recently announced a plan to ensure that Americans receive the best prices on medicines. In a letter sent to leading U.S. pharmaceutical firms, the president outlined steps that they must follow to match the drug prices in other nations.

These steps include requiring drug manufacturers to offer the same prices to U.S. customers as those offered to the global community, and offering manufacturers the opportunity to sell the medications directly to patients, cutting out wholesalers.

The FDA plans to hold a public meeting about the new PreCheck Program on Sept. 30 at the FDA White Oak Campus in Silver Spring, Maryland. The “Onshoring Manufacturing of Drugs and Biological Products” meeting will include a presentation of the new program, followed by a discussion and Q&A.

Dating to 1906, the FDA was established to protect public health by assuring the safety and effectiveness of both human and veterinary drugs, as well as vaccines and other biological products. The agency is also responsible for the safety of the United States’ food supply, dietary supplements, and cosmetics, in addition to regulating tobacco products.