FDA pushes domestic manufacturing agenda

The Food and Drug Administration is no longer talking about drug manufacturing as a quiet supply-chain problem. It is talking about it as industrial policy. On April 7, the agency used the president’s budget rollout to back proposals that would reward companies for making medicines and running early testing in the United States, with Commissioner Marty Makary casting the effort as a response to China’s growing lead in early drug development (statnews.com, cnbc.com). That framing did not come out of nowhere. In May 2025, President Donald Trump signed Executive Order 14293, which told the FDA to cut approval time for domestic drug plants, streamline reviews, and increase fees and inspections for foreign manufacturing sites. The White House described the goal in blunt terms: prioritize American facilities over foreign ones and treat domestic production of medicines as a national-security issue, not just a business decision (whitehouse.gov). The FDA then started building machinery to make that policy real. In October 2025, it launched an ANDA prioritization pilot that offers faster generic-drug reviews to applicants that both manufacture their products in the U.S. and conduct required bioequivalence testing here. The agency tied that pilot to a stark set of numbers: more than half of pharmaceuticals distributed in the U.S. are manufactured overseas, and only 9% of API manufacturers are in the U.S., compared with 22% in China and 44% in India (fda.gov). That same month, the FDA also floated “PreCheck,” a two-phase program meant to speed the launch of high-priority new U.S. drug plants. The idea is simple. Instead of waiting until a facility is built and attached to an application, the FDA would work with selected manufacturers earlier, review facility-specific information before operations begin, and try to clear quality issues before they turn into approval delays. At a September 30, 2025 public meeting, the agency said this was meant to accelerate inspections and application assessment, not just shave paperwork (fda.gov, federalregister.gov). The inspection piece matters because the FDA is pairing domestic incentives with tougher foreign scrutiny. In May 2025, the agency said it would expand unannounced inspections at overseas plants after years of complaints that foreign firms got advance notice while U.S. plants did not. The FDA said it conducts about 12,000 domestic inspections and 3,000 foreign inspections each year, and that serious deficiencies were found more than twice as often in foreign inspections even with advance warning (fda.gov). That is the practical logic behind the new push. If a sponsor moves manufacturing, testing, or both into the U.S., it may gain speed on the front end. It also moves into a system with more direct FDA visibility. Domestic sites are inspected on a risk basis and without the long notice that historically shaped many foreign inspections. GAO has been warning for years that FDA oversight of overseas manufacturing is harder, slower, and distorted by inspection backlogs, staffing gaps, and the old practice of preannouncing many foreign visits weeks in advance (gao.gov, datadashboard.fda.gov). That means “onshoring” is not just a patriotic branding exercise. It is a regulatory trade. Companies may get faster reviews, earlier facility feedback, and a better political fit with the administration’s agenda. In return, they take on more change-control work, more direct inspection exposure, and more opportunities for ordinary manufacturing deviations to surface quickly in complaint files and safety systems. The FDA is effectively telling industry that if it wants the upside of being closer to the agency, it will also get the agency closer to the plant floor (statnews.com, fda.gov).