New Federal Directives to Enhance U.S. Drug Manufacturing: Compliance Insights for Healthcare

On May 5, 2025, President Donald Trump signed the Executive Order on Regulatory Relief to Promote Domestic Production of Critical Medicines, marking a significant move to reduce America's reliance on foreign pharmaceutical manufacturing. This initiative aims to streamline regulatory processes, making it more feasible for domestic facilities to produce essential medicines.

Key directives include:

• FDA Regulatory Streamlining: The Food and Drug Administration (FDA) is tasked with reviewing and eliminating redundant regulations within 180 days to expedite the approval of domestic pharmaceutical manufacturing facilities.

• Enhanced Oversight of Foreign Producers: The FDA will increase inspections of overseas facilities to ensure they meet U.S. standards, aiming to level the playing field for domestic manufacturers.

• Accelerated Facility Construction: The Environmental Protection Agency is directed to expedite the permitting process for building pharmaceutical manufacturing plants in the U.S., addressing the current 5 to 10-year timeline deemed unacceptable for national security.

This executive order underscores a strategic pivot towards bolstering national security through domestic production of critical medicines. Healthcare organizations involved in pharmaceutical manufacturing, supply chain management, or regulatory compliance must assess their operations in light of these changes.

At Lanton Law, we specialize in guiding healthcare businesses through complex regulatory landscapes. Our expertise ensures your organization remains compliant and competitive. To understand how this executive order impacts your operations and to develop a proactive compliance strategy, contact us today.

Biden Administration Files Motion Supporting Canadian Drug Imports

The Biden Administration has filed a motion in federal district court for the District of Columbia. The motion seeks to dismiss a lawsuit that aims to prevent prescription drug imports from Canada. This motion is aimed at prior enacted state legislation from both Florida and New Mexico, as both states have commenced the process of applying for Canadian imports. The Administration argues in its brief that the party opponent’s (Pharmaceutical Research & Manufacturers of America PhRMA) claim is not prudentially ripe.

Importation is an issue that Lanton Law has been monitoring for several years. As the drug pricing debate continues across Congress and state legislatures, we fully anticipate importation to continue to be a front and center policy issue.

Lanton Law is a national boutique regulatory law and lobbying firm that focuses on healthcare/life science and technology. If you are an industry stakeholder with questions about the current landscape or if you would like to discuss how your organization’s strategic initiatives might be impacted by either Congress, regulatory agencies or legal decisions, contact us today.

White House Issues Executive Order Advocating for Importation

The White House has issued an Executive Order titled “Executive Order on Increasing Drug Importation to Lower Prices for American Patients,” which seeks to advocate for having supply chain entities proceed with importation. 

“One way to minimize international disparities in price is to increase the trade of prescription drugs between nations with lower prices and those with persistently higher ones.  Over time, reducing trade barriers and increasing the exchange of drugs will likely result in lower prices for the country that is paying more for drugs.  For example, in the European Union, a market characterized by price controls and significant barriers to entry, the parallel trade of drugs has existed for decades and has been estimated to reduce the price of certain drugs by up to 20 percent.  Accordingly, my Administration supports the goal of safe importation of prescription drugs.” 

The Executive Order gives stakeholders three methods to accomplish the goals of this order. Either allow reimportation of insulin products from Canada, finalize the December 2019 proposed rule addressing importation, or allow individuals to import drugs as long as the importation is designated by the Food & Drug Administration (FDA) as safe and results in lower costs to patients.  

• (a)  facilitating grants to individuals of waivers of the prohibition of importation of prescription drugs, provided such importation poses no additional risk to public safety and results in lower costs to American patients, pursuant to section 804(j)(2) of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 384(j)(2);

• (b)  authorizing the re-importation of insulin products upon a finding by the Secretary that it is required for emergency medical care pursuant to section 801(d) of the FDCA, 21 U.S.C. 381(d); and

• (c)  completing the rulemaking process regarding the proposed rule to implement section 804(b) through (h) of the FDCA, 21 U.S.C. 384(b) through (h), to allow importation of certain prescription drugs from Canada.

Lanton Law is a national boutique law and government affairs firm that focuses on healthcare/life sciences, technology and finance. If you are an industry stakeholder with questions about the current landscape or if you would like to discuss how your organization’s strategic initiatives might be impacted by either Congress, regulatory agencies or legal decisions, contact us today. 

New Draft Importation Rule Released

A new pilot program that allows states to import from Canada and allow manufacturers to voluntarily import has been announced via a draft rule through HHS and the FDA. 

The program would give states and nonfederal government entities the ability to import from Canada by applying to the FDA. Higher priced drugs such as biologics are not included in the draft rule. Here are some of the main points: 

• The drugs must be approved in Canada. 

• It does not include, controls, biologics or intravenously injected drugs. 

• States can work with wholesalers and pharmacies to create an application.

Canadian officials have already stated that the plan is unlikely to work as Canada is only 2% of the global market versus 44% from the U.S. This means that Canada will not be able to meet demand. 

A separate program that would allow for drug company importation of its own products does not take into account rebates or the best-price rule. The program requires that the drugs go through a separate re-labeling and testing that will have an additional cost. Additional costs may either cancel out any savings or make the drugs more expensive. 

This rule is in response to several states such as Florida who have created legislation in 2019 to allow for the importation of drugs from Canada. 

For more information regarding importation in general click here. 

Here is a link to the proposed rule. 

At Lanton Law we help our clients with business strategy, legal, compliance, as well as regulatory and government affairs issues. We help various entities within the supply chain be prepared for tomorrow by knowing the landscape of today. If you have questions or are looking for innovative ways to realize your organization’s priorities, click here to contact us.