Trump Administration Updates for the Health Industry

In the second and third quarters of 2025, the Trump administration and federal agencies have released a number of executive orders and other regulatory actions with potential impacts for the life sciences industry.  Some notable policy activities include most-favored nation drug pricing actions and modifications to policy regarding foreign pharmaceutical manufacturing sites.  Many of the below actions remain the subject of ongoing litigation.

Administration Decides Against Obesity Drug Coverage Proposal

• On Friday, April 4, CMS, in its Calendar Year 2026 Medicare Advantage and Part D Rate Announcement, decided against expanding Medicare Advantage and Medicare Part D coverage to anti-obesity medications. The determination followed an earlier proposal under the Biden Administration to expand coverage to such medications.

White House Directs Agencies to Repeal Regulations Deemed Unlawful

• On Thursday, April 9, the White House issued a Presidential Memorandum directing federal agencies to repeal regulations that officials deem “unlawful” and “in particular, evaluating each existing regulation’s lawfulness under [] United States Supreme Court decisions,” including Loper Bright. The memorandum instructed agencies to finalize rules “without notice and comment, where doing so is consistent with the “good cause” exception in the Administrative Procedure Act.”

USDA Halts Biden-Era Rules on Salmonella in Poultry

• On Thursday, April 24, the USDA announced the withdrawal of a proposed Biden-era rule, Salmonella Framework for Raw Poultry Products. The rule “was targeted at reducing Salmonella illnesses associated with poultry products.”

  FDA Announces Collection of Information on Drug Compounding

• On Wednesday, April 30, FDA announced a collection of information on drug compounding practices, noting that “FDA continues to find concerning quality and safety problems during inspections of outsourcing facilities.” FDA plans to send outsourcing facilities surveys covering issues including “outsourcing facilities’ challenges when implementing Federal [Current Good Manufacturing Practices] requirements,” outsourcing facilities’ understanding of the Federal laws and policies that apply to them, and “financial and operational considerations inform[ing] outsourcing facility product decisions.”

  HHS and NIH to Develop “Universal” Vaccine

• On Thursday, May 1, HHS and the National Institutes of Health (NIH) announced an investment of $500 million in the development of a “universal vaccine.” According to NIH, the technology “extends vaccine protection beyond strain-specific limits and prepares for flu viral threats – not just today’s, but tomorrow’s as well – using traditional vaccine technology brought into the 21st century.”

  HHS Issues Report on Health Care for Transgender Youth

• On Thursday, May 1, HHS’s Office of the Assistant Secretary for Health and Office of Population Affairs released a review of transgender health care, pursuant to President Trump’s Executive Order. The report “summarizes, synthesizes, and critically evaluates the existing literature on best practices for promoting the health and wellbeing of children and adolescents with distress related to their sex or to social expectations associated with their sex.” The key recommendation from the report reads: “A more robust evidence base supports psychotherapeutic approaches to managing common comorbid mental health conditions. Psychotherapy is a noninvasive alternative to endocrine and surgical interventions for the treatment of pediatric gender dysphoria. Systematic reviews of evidence have found no evidence of adverse effects of psychotherapy in this context.”

  Administration Announces Cuts to DEA, CDC, NIH, and Other HHS Agencies

• On Friday, May 2, as part of broader recommendations on discretionary funding for fiscal year 2026, the Trump administration recommended various cuts to HHS and other health-related agencies. The recommendations include a $3.588 billion cut to the Centers for Disease Control (CDC), a $17.965 billion cut to NIH, a $674 million cut to CMS, and many other cuts.

President Trump Signs Executive Order to Limit Funding for Gain-of-Function Research

• On Monday, May 5, President Trump signed an executive order, “Improving the Safety and Security of Biological Research,” relating to gain-of-function research. The executive order refers to gain-of-function research as “dangerous” and suggests that “if unaddressed, [such research]may lead to the proliferation of research on pathogens (and potential pathogens) in settings without adequate safeguards, even after COVID-19 revealed the risk of such practices.” The order “end[s] Federal funding of dangerous gain-of-function research conducted by foreign entities in countries of concern” or inadequate oversights and orders the Director of Science and Technology Policy to revise or replace the 2024 “United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential.”

  President Trump Signs Executive Order to Streamline Approval for Domestic Pharmaceutical Manufacturing

• On Monday, May 5, President Trump signed an executive order, “Regulatory Relief to Promote Domestic Production of Critical Medicines,” with the stated intent of “eliminat[ing] regulatory barriers to the domestic production of the medicines Americans need.” The order directs FDA to “review existing regulations and guidance that pertain to the development of domestic pharmaceutical manufacturing,” “take steps to eliminate any duplicative or unnecessary requirements in such regulations and guidance,” and “maximize the timeliness and predictability of agency review.” Specific proposals include “evaluat[ing] the current risk-based approach to prior approval of licensure inspections, including when such inspections are necessary” and “develop[ing] and advance[ing] improvements to the risk-based inspection regime that ensures routine reviews of overseas manufacturing facilities.”

  FDA to Expand Use of Unannounced Manufacturing Facility Inspections Overseas

• On Tuesday, May 6, FDA Commissioner Marty Makary announced that FDA will expand its use of unannounced manufacturing facility inspections overseas “to ensure that foreign companies will receive the same level of regulatory oversight and scrutiny as domestic companies.”

  President Trump Signs Executive Order Urging Civil Enforcement over Criminal Penalties

• On Friday, May 9, President Trump signed an executive order directing federal agencies to prioritize civil rather than criminal enforcement of their regulations and providing that “[s]trict liability criminal regulatory offenses are disfavored.” The order requires agencies to submit to the Office of Management and Budget a comprehensive “list of all criminal regulatory offenses enforceable by the agency or the Department of Justice” and “the range of potential criminal penalties for a violation and the applicable mens rea standard for the criminal regulatory offense.”

President Trump Signs Executive Order on Most-Favored Nation Drug Prices

• On Monday, May 12, President Trump signed an executive order, “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients,” directing the federal government to ensure that American patients pay no more for prescription drugs and biologics than the lowest price paid in other developed nations—the “most-favored-nation” price. The order directs the HHS Secretary to communicate most-favored-nation price targets to pharmaceutical manufacturers within 30 days, and to propose rulemaking to impose most-favored-nation pricing if significant progress toward the pricing is not delivered. The order also instructs HHS to consider the allowance of direct-to-consumer sales for compliant companies and “certification to the Congress that importation under section 804(j) of the Federal Food, Drug, and Cosmetic Act (FDCA) will pose no additional risk to the public’s health and safety and result in a significant reduction in the cost of prescription drugs to the American consumer.” Finally, the order directs the Secretary of Commerce “take all necessary and appropriate action to ensure foreign countries are not engaged in any act, policy, or practice that may be unreasonable or discriminatory or that may impair United States national security and that has the effect of forcing American patients to pay for a disproportionate amount of global pharmaceutical research and development, including by suppressing the price of pharmaceutical products below fair market value in foreign countries.” HHS later announced that the most-favored nation target price would be set to “the lowest price in an OECD country with a GDP per capita of at least 60 percent of the U.S. GDP per capita.”

CMS Issues Draft Guidance for Drug Price Negotiation Program

• On Monday, May 12, CMS issued draft guidance for public comment on the third cycle of negotiations under the Medicare Drug Price Negotiation Program. The draft guidance “includes policies that will improve the transparency of the Negotiation Program, prioritize the selection of prescription drugs with high costs to the Medicare program, and minimize any negative impacts of the negotiated maximum fair price (MFP) on pharmaceutical innovation within the United States.” It also addresses “new policies to incorporate drugs payable under Part B into the Negotiation Program for the first time,” “solicits comments on how to facilitate access to any negotiated MFPs for drugs payable under Part B, and “includes clarifications regarding how participating manufacturers would make any negotiated MFPs available in 2026 and 2027 and extends such policies for drugs covered under Part D to 2028.”

  HHS Rescinds Guidance, Including on COVID-19 and Gender Identity Discrimination

• On Tuesday, May 13, as part of a deregulatory initiative, HHS rescinded four agency guidance documents, including (i) an extension of a designation of certain materials as scarce in order to prevent hoarding during the COVID-19 pandemic, (ii) an interpretation of Section 1557 of the Patient Protection and Affordable Care Act (ACA) aimed at preventing discrimination based on gender identity, (iii) guidelines on the administration of buprenorphine for opioid use disorder treatment, and (iv) a 2001 opioid treatment-related action.

  CMMI Unveils New Strategic Direction

• On Tuesday, May 13, CMMI unveiled a new strategic direction focused on prompting evidence-based prevention, empowering people to achieve their health goals, and driving choice and competition. The Center also issued a related white paper. Therein, CMMI announced the implementation of future waivers “that support predictable cost-sharing for certain services, drugs, or devices that improve outcomes and reduce costs as well as value-based drug and insurance designs,” of models that utilize mobile health applications, and of a waiver for use of durable medical equipment “that may bypass National Coverage Determinations if they support transition to or remaining in the home.”

  CMS Issues Request for Information on Digital Health

• On Tuesday, May 13, CMS issued a request for information (RFI) on the market of digital health products for Medicare beneficiaries and the state of data interoperability and health technology infrastructure. The RFI emphasized potential uses and regulations regarding digital health applications and the use of digital health technologies in value-based care models.

Administration Will No Longer Enforce Mental Health Parity Rule

• On Thursday, May 15, the Departments of Labor, HHS, and Treasury announced that they will not enforce a 2024 Biden-era rule, titled “Requirements Related to the Mental Health Parity and Addiction Equity Act,” until a related lawsuit is resolved and 18 months thereafter. The rule imposes a test on employers to ensure that health plans cover mental health care in an equal manner as other medical services.

FDA Announces Changes to Section 804 Importation Approach

• On Wednesday, May 21, FDA announced “enhancements to the pathway under section 804 of the Federal Food, Drug and Cosmetic Act that allows states and Indian tribes to import certain prescription drugs from Canada to significantly reduce the cost of these drugs to the American consumer, without imposing additional risk to public health and safety.” FDA plans to offer states and tribes “the opportunity to submit a draft proposal for pre-review and meet with the agency to obtain initial feedback from FDA prior to formally submitting their section 804 importation program (SIP) proposal.” Additionally, FDA intends to “develop a user-friendly tool that will assist states in developing their proposals” and “provide input regarding the information states may rely on as they estimate cost savings for American consumers.”

HHS Issues RFI on Improving Drug Price Transparency

• On Thursday, May 22, HHS, along with the departments of Labor and Treasury, issued an RFI regarding “the prescription drug machine-readable file disclosure requirements in the Transparency in Coverage final rules.” The departments seek public feedback on how to “effectively implement or amend the disclosure requirements related to prescription drug expenditures” under the Transparency in Coverage final rule issued in 2020. The RFI follows a February Executive Order ” to prioritize improving existing price transparency requirements and ensuring that patients have the information they need to make well-informed decisions about their healthcare.”

Administration Releases “Make America Healthy Again” Report

• On Thursday, May 22, the President’s Make America Health Again Commission, led by HHS Secretary Robert F. Kennedy, released a report about childhood chronic diseases. The report emphasizes “four potential drivers behind the rise in childhood chronic disease that present the clearest opportunities for progress:” poor diet, aggregation of environmental chemicals, lack of physical exercise and chronic stress, and overmedicalization, including “a concerning trend of overprescribing medications to children, often driven by conflicts of interest in medical research, regulation, and practice.”

CMS Seeks Feedback on Hospital Compliance and Enforcement of Price Transparency Requirements

• On Thursday, May 22, CMS issued an RFI seeking comment to help “identify challenges and improve compliance and enforcement processes related to the transparent reporting of complete, accurate, and meaningful pricing data by hospitals.” CMS also issued new guidance reforming and updating the Hospital Price Transparency program. The guidance requires “encod[ing] a standard charge dollar amount in the machine-readable file (MRF) if it can be calculated, including the amount negotiated for the item or service, the base rate negotiated for a service package, and a dollar amount if the standard charge is based on a percentage of a known fee schedule.” The intent is to require “the disclosure of the actual prices of items and services, not estimates.”

DOJ Civil Division Publishes New Priorities

• On Wednesday, June 11, Assistant Attorney General Brett Shumate released a new memorandum naming the DOJ Civil Division’s enforcement priorities. Pursuant to an Attorney General directive to “to undertake appropriate investigations of any violations of the Food, Drug, and Cosmetic Act by manufacturers and distributors engaged in misbranding by making false claims about the on- or off-label use of puberty blockers, sex hormones, or any other drug used to facilitate a child’s so-called ‘gender transition,’” the memorandum states that the Civil Division will “prioritize investigations of doctors, hospitals, pharmaceutical companies, and other appropriate entities.” That focus will include investigations into potential violation of the FDCA by “pharmaceutical companies that manufacture drugs used in connection with so-called gender transition” and “dealers such as online pharmacies suspected of illegally selling such drugs.”

  FDA Unveils Voucher Plan to Shorten Drug Reviews

• On Tuesday, June 17, FDA announced the Commissioner’s National Priority Voucher program, a new plan that seeks to reduce drug review times for select new drugs to one to two months, rather than the current average of ten to twelve months, for companies aligned with national interests. FDA may issue the vouchers for specific experimental drugs or grant them to companies for use on any drug development in line with the program’s goals, such as “addressing public health crises, providing innovative cures for Americans, meeting public health needs or increasing domestic drug manufacturing.”

• On Monday, June 30, FDA announced it is now requiring the labeling of extended-release stimulants used to treat attention-deficit hyperactivity disorder with a “limitation of use” section, which will include a statement on higher rates of adverse reactions in children under age six.

  CDC Accepts ACIP RSV and Meningococcal Disease Vaccine Recommendations

• On Wednesday, July 2, it was reported that CDC has accepted recommendations from the Advisory Committee on Immunization Practices for the use of vaccines against respiratory syncytial virus and meningococcal disease.

  DOJ, HHS Form False Claims Act Working Group

• On Wednesday, July 2, HHS and DOJ announced the formation of the DOJ-HHS False Claims Act Working Group, which will include leadership from the HHS Office of General Counsel, the CMS Center for Program Integrity, the Office of Counsel to the HHS Office of Inspector General, and DOJ’s Civil Division, with designees representing U.S. Attorneys’ Offices. The working group’s priority enforcement areas will include Medicare Advantage; drug, device, or biologics pricing; barriers to patient access to care; kickbacks related to drugs, medical devices, durable medical equipment, and other products; materially defective medical devices; and manipulation of Electronic Health Records systems to drive inappropriate utilization.

  FDA Exemptions for Screening of Low-Value Import Shipments Revoked

• On Tuesday, July 15, it was reported that the FDA had announced that, going forward, it will review all imports of products that the agency regulates, regardless of their quantity or value. These updated regulations, effective July 9, revoke exemptions that previously allowed import of certain shipments valued at $800 or less without a full FDA screening.

  FDA Revokes More Than Fifty Standards of Identity for Food Products

• On Wednesday, July 16, FDA announced that it is revoking or proposing to revoke 52 food standards because “they are obsolete and unnecessary.” Building on the Trump administration’s deregulatory efforts, these actions include a direct final rule rescinding standards for canned fruits and vegetables that are no longer sold in the United States, a proposed rule that would eliminate standards for several dairy products, and a proposed rule that would revoke standards for 23 other types of food products (e.g., bakery products, macaroni and noodle products, canned fruit juices, fish and shellfish, and food dressings).

  FDA, NIH Announce Joint Initiative to Tackle Dietary Issues

• On Friday, May 9, FDA and NIH announced the launch of a joint Nutrition Regulatory Science Program to address diet-related chronic diseases with the intent of informing effective food and nutrition policies. The research initiative aims to investigate the health impacts of ultra-processed foods, food additives, and maternal and infant dietary exposures, with the goal of developing evidence-based policies and increasing transparency about food and health.

  FDA Begins Process to Remove Ingestible Fluoride Prescription Drug Products for Children from Market

• On Tuesday, May 13, FDA announced that “it is initiating action to remove concentrated ingestible fluoride prescription drug products for children from the market.” In the announcement, FDA Commissioner Makary stated “[t]he best way to prevent cavities in children is by avoiding excessive sugar intake and good dental hygiene, not by altering a child’s microbiome. For the same reason that fluoride may kill bacteria on teeth, it may also kill intestinal bacteria important for a child’s health.” FDA aims to complete a safety review and public comment period by October 31, 2025, after which it will take further action.

  FDA to Expand Review of Chemical Preservatives Used in Food

• On Thursday, May 15, FDA announced the launch of “a stronger, more systematic review process for food chemicals already on the market—especially those that concern consumers most.” The proposed review process will include a “modernized, evidence-based prioritization scheme for reviewing existing chemicals,” a “final, systematic post-market review process shaped by stakeholder input,” an “updated list of chemicals under review, including BHT, BHA, and ADA,” and expedited “review of chemicals currently under review like phthalates, propylparaben, and titanium dioxide.”

  FDA Publishes Guidance on Color Additives in Drug Products

• On Thursday, May 29, FDA released new draft guidance with recommendations “for replacing color additives in approved or marketed drug products.” FDA recommends that companies with “new drug application[s] and abbreviated new drug application[s] submit information to support color additive replacements in changes being effected in 30 days (CBE-30) supplements.” The draft guidance emphasizes that while “a qualitative or quantitative change to an inactive ingredient is generally considered a major change, in many cases, replacing a color additive with one that is listed in the color additive regulations is unlikely to adversely affect the identity, strength, quality, purity, or potency of the drug product.”

  FDA Unveils AI-Tool Aiming to Enhance Agency’s Efficiency

• On Monday, June 2, FDA announced in a press release that it launched Elsa, a generative artificial intelligence (AI) tool aimed to help employees work more efficiently. Elsa can, among other functionalities, summarize adverse events to support safety profile assessments, perform label comparisons more quickly, and generate code to develop databases for nonclinical applications.

HHS Considering Funding of New Ebola and Marburg Vaccines

• On Friday, June 27, the HHS Center for the Biomedical Advanced Research and Development Authority (BARDA) issued a federal pre-solicitation notice of its interest in soliciting proposals to develop and license vaccines for Marburg and Sudan Ebola viruses.

FDA Publishes Tranche of Complete Response Letters

• On Thursday, July 11, FDA published more than 200 complete response letters, decision letters issued in response to applications submitted to FDA for drug or biological product approval between 2020 and 2024. The Agency plans to publish additional complete response letters from its archive, as part of an effort to increase transparency.

HHS Praises Dairy Industry for Pledging to Remove Artificial Food Dyes from Ice Cream by 2028

• On Monday, July 14, HHS announced in a press release that it was pleased with the International Dairy Foods Association’s announcement that the dairy industry had committed to remove artificial food dyes from ice cream by 2028. A group of 40 producers that collectively make more than 90% of the ice cream sold in the United States pledged to remove Red No. 3, Red 40, Green 3, Blue 1, Blue 2, Yellow 5, and Yellow 6 by the end of 2027.

FDA Approves Gardenia Blue Color Additive Derived from a Natural Source

• On Monday, July 14, FDA announced that it had granted Gardenia Blue Interest Group’s petition to use the color gardenia blue in certain foods, such as sports drinks, flavored waters, fruit drinks, ready-to-drink teas, and candy. Gardenia blue comes from the fruit of the gardenia (a flowering evergreen and natural source). According to FDA Commissioner Marty Makary, expanding options of colors derived from natural sources will facilitate a shift away from petroleum-based dyes.

CMS Announces New Model to Enhance Patient Access to Therapies for Sickle Cell Disease

• On Tuesday, July 15, CMS announced that 33 states, as well as the District of Columbia and Puerto Rico, will participate in the Cell and Gene Therapy (CGT) Access Model, which seeks to offer cutting-edge treatments to Medicaid recipients who are living with sickle cell disease. Taking an innovative approach, CMS negotiated outcomes-based agreements directly with CGT manufacturers on behalf of state Medicaid agencies.

Senate Confirms Bhattacharya to Lead NIH, Makary to Head FDA, and Oz to Lead CMS

• On Tuesday, March 25, the Senate voted to confirm Jay Bhattacharya, a Stanford University health economist and physician, to lead NIH, and Marty Makary, a surgeon at Johns Hopkins Medicine, to lead FDA. On Thursday, April 3, the Senate voted 53-45 to confirm Dr. Mehmet Oz as administrator of CMS.

FDA Vaccine Head Named Chief Medical and Scientific Officer

• On Wednesday, June 18, it was reported that FDA’s head of vaccines, Vinay Prasad, had been selected as the agency’s chief medical and scientific officer.

HELP Committee Approves Nomination for HHS Assistant Secretary for Health

• On Wednesday, July 16, the Senate HELP Committee held a hearing on the nomination of Brian Christine to serve as HHS Assistant Secretary for Health. His nomination was approved on July 24, 2025.

HHS Announces Investigation into Organ Procurement Organization

• On Monday, July 21, the U.S. Department of Health and Human Services (HHS) announced a “major initiative to begin reforming the organ transplant system.” The press release details findings of an ongoing HHS investigation into patient treatment practices of an unnamed federally funded Organ Procurement Organization (OPO).

HHS Issues Notice Announcing Drug Rebate Pilot Program

• On Thursday, July 31, HHS issued a notice announcing a limited pilot program that would require health providers that treat lower-income and uninsured patients under the federal 340B Drug Pricing Program to buy certain medicines at full price and then submit data to the program to receive a rebate.

Trump Signs Pharmaceutical Supply Chain Executive Order

• On Wednesday, August 13, President Trump signed an Executive Order that seeks to ensure “resilient” supply chains for essential medicines in the United States by filling the Strategic Active Pharmaceutical Ingredients Reserve with critical drug components. In a fact sheet, the White House noted that the Department of Health and Human Services’ (HHS) Office of the Assistant Secretary for Preparedness and Response should make a list of roughly 26 drugs essential to “national health and security.”