Trump Moves to Streamline Pharmaceutical Regulations in Ongoing Bid to Reshore American Manufacturing
President Donald Trump’s tariff agenda has been the subject of much debate over the past several weeks, following his “Liberation Day” announcement, but as the president sets his sights on reshoring pharmaceutical manufacturing, a number of small and mid-size American manufacturers have reported that tariffs are already on their way to revitalizing the American economy.
The president signed an executive order Monday to “reshore” and “onshore” pharmaceutical manufacturing jobs. “That’s what it’s all about,” he quipped as he signed the order. The order, “Regulatory Relief to Promote Domestic Production of Critical Medicines,” recounted efforts made during the first Trump administration to “improve the well-being of the American people by restoring capacity for domestic production of critical pharmaceutical products,” but observed, “Unfortunately, the prior administration did too little to advance these goals. Critical barriers and information gaps persist in establishing a domestic, resilient, and affordable pharmaceutical supply chain for American patients.”
Noting that numerous regulations and requirements at the federal, state, and sometimes local level drastically increase “the length of time it takes to build pharmaceutical manufacturing facilities in the United States today,” sometimes as long as five to 10 years, the order stated. “It is in the best interest of the Nation to eliminate regulatory barriers to the domestic production of the medicines Americans need.” The order also pointed out that unannounced Food and Drug Administration (FDA) inspections are far more common at facilities in the U.S. than U.S.-owned facilities overseas, creating a further incentive for pharmaceutical companies to offshore production.
The order directs Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary to “review existing regulations and guidance that pertain to the development of domestic pharmaceutical manufacturing and … take steps to eliminate any duplicative or unnecessary requirements in such regulations and guidance,” in addition to “maximiz[ing] the timeliness and predictability of agency review; and streamlin[ing] and accelerat[ing] the development of domestic pharmaceutical manufacturing.”
The FDA commissioner will, according to the order, review FDA inspection schedules to “streamline” the process and ensure that inspections occur only when necessary, improve programs to “provide early technical advice before a facility is operational,” bolster enforcement of data reporting requirements at both domestic and overseas manufacturing facilities, and clarify guidance for facility improvement, including recommending moving overseas facilities to the U.S. The order also stipulates enhancing and increasing FDA inspections of overseas manufacturing facilities, to ensure that safety standards and regulations are being met.
In comments to The Washington Stand, HHS Deputy Press Secretary Emily Hilliard said that the agency "is committed to strengthening the domestic pharmaceutical supply chain." She continued, "Under the Executive Order, the agency can prioritize the review of U.S.-based manufacturing facilities and reduce unnecessary regulatory delays — steps that may encourage domestic investment and create American jobs in pharmaceutical production and advanced manufacturing." Hilliard added, "The agency will continue to uphold the Gold Standard of Science while supporting efforts to expand and secure U.S. manufacturing capabilities."
Already, the president’s efforts to reshore American manufacturing jobs are having some effect. Pharmaceutical giant AstraZeneca announced a $3.5 billion investment plan in the U.S., including opening a $300 million manufacturing facility in Rockville, Maryland, this week. Pharmaceutical company Gilead also announced an $11 billion investment in the U.S., including $5 billion in technology, operations, and research and development, Bristol Myers Squibb announced a $40 billion investment, and Johnson and Johnson announced a plan to invest over $55 billion in the U.S. over the course of Trump’s presidency, including the construction of three new manufacturing sites, in addition to another manufacturing site already being built in North Carolina.
Other companies have also lined up to produce in the U.S. Kleenex tissue and Huggies diaper maker Kimberly-Clark announced a $2 billion U.S. investment, including building a new manufacturing facility in Ohio and expanding a facility in South Carolina. The Volkswagen Group is planning to shift much of the production for its luxury brand, Audi, to the U.S., following the example of other automakers who are returning factories to America, and IBM has pledged $150 billion towards boosting U.S. manufacturing.
According to a report from The Wall Street Journal, U.S. manufacturing companies have also seen a recent spike in business, thanks to the president’s tariffs. Due to the increased cost of imported foreign goods, companies are turning to American manufacturers instead of factories overseas. “We are swamped. We are running 24 hours a day, seven days a week in both Chicago and Cleveland,” Jergens, Inc. president Jack Schron reported. The Ohio-based Grand River Rubber & Plastics has seen clients return who had gone to Chinese companies years ago, and Louisiana-based SafeSource Direct restarted multiple production lines in order to fulfill a slew of new orders. “We were getting stiffed for a very long time, but just recently we’ve been getting a lot more inquiries,” Safesource chief growth officer Alan Rust told WSJ.
The Washington Post reported that the president’s tariffs have greatly benefited domestic production and manufacturing companies such as Excel Dryer. The company’s chief operating officer, William Gagnon, predicted, “The reciprocal tariff approach is really going to open up more international markets for us.” Gagnon explained that the tariffs “make domestic suppliers more competitive while also discouraging Americans from purchasing cheap Chinese copies of Excel’s hand dryers.”
S.A. McCarthy serves as a news writer at The Washington Stand.