backOn May 5, 2025, President Donald J. Trump issued Executive Order (“EO”) 14293 entitled Regulatory Relief to Promote Domestic Production of Critical Medicines.1Exec. Order 14293, Regulatory Relief to Promote Domestic Production of Critical Medicines (May 5, 2025), https://www.whitehouse.gov/presidential-actions/2025/05/regulatory-relief-to-promote-domestic-production-of-critical-medicines/. The EO directs the U.S. Food and Drug Administration (“FDA”), U.S. Environmental Protection Agency (“EPA”), and U.S. Army Corps of Engineers to “eliminate regulatory barriers to the domestic production of the medicines Americans need.”2Id. Key objectives of the EO include eliminating “duplicative or unnecessary regulations and guidance” that may delay domestic pharmaceutical manufacturing, increasing fees and inspections imposed on foreign manufacturing facilities, and streamlining the permitting process for U.S.-based pharmaceutical manufacturing facilities.3Id.
Focus on pharmaceutical manufacturing
EO 14293 builds on President Trump’s August 2020 Executive Order entitled Combating Public Health Emergencies and Strengthening National Security By Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made In The United States.4Exec. Order No. 13944, 85 Fed. Reg. 49,929 (Aug. 14, 2020), https://www.federalregister.gov/documents/2020/08/14/2020-18012/combating-public-health-emergencies-and-strengthening-national-security-by-ensuring-essential. The 2020 EO sought to reduce U.S. dependence on foreign manufacturing of essential medicines, medical countermeasures, and critical inputs, and accelerate long-term domestic production of these products.
EO 14293 builds on the 2020 EO and focuses on promoting expanded “domestic pharmaceutical manufacturing” for critical products. EO 14293 declares that the typical five-to-10-year process to build new domestic manufacturing capacity is not in the national security interest of the United States. The EO directs FDA to review its regulations and guidance with an eye on streamlining new and expanded domestic manufacturing capacity, all in an effort to reduce the timeline for adding domestic manufacturing capacity.
Key Provisions of EO 14293
EO 14293 lays out an action plan, with broad objectives for multiple federal agencies to accomplish within 180 days of issuance of the EO:
U.S. Food and Drug Administration
Under the EO, the FDA Commissioner is tasked with reviewing and updating regulations to streamline domestic pharmaceutical manufacturing, with a general charge to “take steps to eliminate any duplicative or unnecessary requirements in such regulations and guidance; maximize the timeliness and predictability of agency review; and streamline and accelerate the development of domestic pharmaceutical manufacturing.” Specific directives for FDA include:
- Evaluating the current risk-based approach to prior approval of licensure inspections, including when such inspections are necessary, and seek to improve upon this approach to ensure all required inspections are prompt, efficient, and limited to what is necessary to ensure compliance with the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) and other federal laws;
- Identifying and undertaking measures necessary to expand, as practicable, existing programs that provide early technical advice before a facility is operational;
- Identifying and undertaking measures necessary to improve compliance with the CARES Act mandate (see FD&C Act § 510(j)(3)) imposed on drug manufacturing facilities to report annually the amounts of active pharmaceutical ingredient (“API”) and finished drug products they manufacture for commercial distribution, including possibly by publicly displaying a list of facilities, including foreign facilities, that are not in compliance;
- Providing clearer guidance regarding the requirements or recommendations for site changes, including moving production from a foreign to a domestic facility, and validation of new or updated components necessary in manufacturing; and
- Reviewing and, as appropriate, seeking to update any other relevant compliance policies, guidance documents, and regulations.
U.S. Environmental Protection Agency
Like FDA, the EPA is given several mandates under the EO, including:
- Eliminating any “duplicative and unnecessary requirements and maximize the timeliness and predictability of agency review” related to the inspection and approval of new or expanded domestic pharmaceutical manufacturing; and
- Serving as the lead agency for the permitting of pharmaceutical manufacturing facilities that require an Environmental Impact Statement and working with other agencies to expedite the review and approval of relevant permits.542 U.S.C. § 4321, et seq.
U.S. Army Corps of Engineers
For its part, the U.S. Army Corps of Engineers is directed by the EO to review the permit process established under the Clean Water Act of 1972 (33 U.S.C. § 1344) and the Rivers and Harbors Appropriation Act of 1899 (33 U.S.C. § 403) and assess “whether an activity-specific nationwide permit is needed to facilitate the efficient permitting of pharmaceutical manufacturing facilities.”6Exec. Order. 14293.
Key Takeaways
A goal of the Trump Administration is to dramatically expand domestic pharmaceutical manufacturing. In pursuit of that strategic objective, in April 2025, the U.S. Department of Commerce initiated a national security investigation into pharmaceuticals and pharmaceutical ingredients under Section 232 of the Trade Expansion Act (see 19 U.S.C. § 1862). This investigation appears intended to lay the predicate for imposing tariffs to encourage domestic pharmaceutical manufacturing. In fact, many pharmaceutical companies have announced plans to move manufacturing to the United States.7See, e.g., Annalee Armstrong, “With Pharma Throwing Billions At US Manufacturing, Where Is The Cash Going?,” BioSpace (Apr. 29, 2025) (“Major pharmaceutical companies are committing billions to US manufacturing in an effort to avoid steep tariffs threatened by President Donald Trump.”); Megan Cerullo, “These companies say they're investing more in U.S. manufacturing as tariffs go into effect,” CBS News (Apr. 30, 2025) (“Since the start of President Trump’s second term in office, a number of corporations have announced plans to expand their production capabilities in the U.S.”).This objective, however, will be difficult to achieve quickly under current conditions, as it typically requires between five and 10 years to bring new and expanded domestic manufacturing capacity online. Therefore, as a complement to the tariff strategy, EO 14293 can be understood as an effort to speed onshoring of domestic manufacturing capacity by removing federal regulatory obstacles.
As another prong in the strategy, EO 14293 also attempts to address a perceived imbalance of regulatory oversight between the domestic and foreign inspection process by increasing the number of foreign inspections. Separately, on March 6, 2025, FDA stated its intention to expand the use of unannounced inspections at foreign manufacturing facilities.8U.S. Food & Drug Admin., FDA Announces Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities (updated May 6, 2025), https://www.fda.gov/news-events/press-announcements/fda-announces-expanded-use-unannounced-inspections-foreign-manufacturing-facilities. Historically, FDA typically pre-announces foreign inspections (due to the travel logistics), while many domestic inspections are unannounced.
It is worth noting that domestic manufacturing has always had one regulatory advantage over foreign facilities when it comes to an adverse inspection. If FDA finds significant violations of current good manufacturing practice (“cGMP”) regulations, it can prevent importation of medical products based on the “appearance of a violation” and effectively remove foreign-manufactured products from the U.S. market during the six to 18 months it typically takes to resolve the situation. In contrast, the U.S. government must file a lawsuit seeking an injunction to remove from the U.S. market product manufactured by a domestic manufacturer. Such injunctions, in practical effect, operate to shut down a manufacturing facility; a consent decree (i.e., the settlement of an injunction action) has the same effect.
We read EO 14293 to apply not only to small-molecule drug products but also to large-molecule biologics. FDA generally considers “pharmaceutical manufacturing” to encompass pharmaceutical products, APIs, and associated raw materials. FDA's cGMP regulations, for example, “outline the minimum quality standards for manufacturing drugs, including biologics.”9U.S. Food & Drug Admin., Developing and Manufacturing Drugs Including Biologics (updated Dec. 30, 2020), https://www.fda.gov/drugs/coronavirus-covid-19-drugs/developing-and-manufacturing-drugs-including-biologics. Additionally, FDA's guidance documents emphasize that biological products are a subset of drugs and, as such, are regulated under both the Public Health Service Act and the FD&C Act. 10See id. U.S. Food & Drug Admin., Frequently Asked Questions About Therapeutic Biological Products (updated May 16, 2024), https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/frequently-asked-questions-about-therapeutic-biological-products.
With the Trump Administration as a potential willing partner, we recommend that pharmaceutical and biologics manufacturers review planned and ongoing projects to build new or expanded manufacturing capability, or to redeploy current capability. The objective would be to develop proactive proposals for specific regulatory modifications, whether a quicker review timeline, a streamlined process, or increased uniformity (e.g., the pending rule on facility licensing affecting state-level variability), that FDA could utilize to reduce the overall regulatory timeline without compromising safety or quality. FDA may be receptive, since the proposals could give FDA early wins and success stories attributable to EO 14293. These early wins could also provide valuable experience for FDA as it complies with the EO’s requirement to modify regulations and guidance to lock in a shortened timeline for the expansion of domestic pharmaceutical manufacturing.
King & Spalding attorneys continue to monitor the developing landscape and its potential impact on the FDA & Life Science industry.