Executive Orders and Policy Updates

Since President Trump's inauguration, the Trump administration has issued a number of executive orders and policy actions with potential impacts for the life sciences industry. Notable actions include rescinding Biden-era initiatives on health care access and equity, withdrawing from the World Health Organization, reducing indirect costs for NIH grants, and suspending foreign aid.

While many of these actions may be subject to ongoing litigation, which is not addressed here, summaries of certain of these executive orders and policy actions are included below.

Executive Order Rescinding Biden Administration Initiatives
In his first Executive Order on January 20, 2025, President Trump rescinded 78 executive actions implemented by the Biden administration, including health care initiatives. The actions included:

• A directive requiring the Department of Health and Human Services ("HHS") to research and report on the risks and benefits of AI;
• An Executive Order directing health agencies to identify and expand access to COVID-19 treatments;
• An Executive Order directing Medicare to research ways to lower drug costs; and
• Actions aimed at expanding access to health care under the Patient Protection and Affordable Care Act.
  

Executive Order Directing Withdrawal From World Health Organization
President Trump issued an Executive Order on January 20, 2025, providing notice of the United States' intention to withdraw from the World Health Organization ("WHO"). The order cited the "organization's mishandling of the COVID-19 pandemic … and other global health crises, its failure to adopt urgently needed reforms, and its inability to demonstrate independence from the inappropriate political influence of WHO member states" as reasons for the withdrawal.

Executive Order Implementing a Freeze on Regulatory Actions
On January 20, 2025, the Trump administration issued a regulatory freeze across executive departments and agencies, directing the agencies not to propose or issue new rules before securing a Trump appointee's approval. The order also instructs agencies to consider postponing the effective dates of already published rules for 60 days.

Executive Order Integrating "Department of Government Efficiency" Into Federal Government
The Trump administration issued an Executive Order on January 20, 2025, integrating the Department of Government Efficiency ("DOGE")—President Trump's commission to cut federal spending—into the federal government by renaming the U.S. Digital Service as the U.S. DOGE Service. The U.S. Digital Service was created under the Obama administration to modernize the federal government's approach to technology.

Executive Order Recognizing Two Sexes
On January 20, 2025, President Trump signed an Executive Order requiring the U.S. government to recognize only two sexes—male and female—defined based on reproductive cells present at conception. The order requires federal agencies and officials to use the term "sex," rather than "gender," "[w]hen administering or enforcing sex-based distinctions" in federal policies and documents, including by issuing government documents that "accurately reflect the holder’s sex." The directive also requires agencies managing prisons and shelters to "ensure that intimate spaces designated for women, girls, or females … are designated by sex not identity." Further, it instructs the Bureau of Prisons to "ensure that no Federal funds are expended for any medical procedure, treatment, or drug for the purpose of conforming an inmate's appearance to that of the opposite sex."

Executive Order Reaffirming Hyde Amendment Concerning Restriction of Federal Dollars for Abortion Services
On January 24, 2025, President Trump issued an Executive Order reaffirming the Hyde Amendment, which prevents the federal government from providing funding for abortions. The order indicates that the Emergency Medical Treatment and Labor Act, or EMTALA, and HIPAA remain in effect. The order alsoreinstated the "Mexico City Policy" to "ensure" that no federal funds are used for abortions overseas.

Executive Order Restricting Gender-Affirming Care for Minors, Defined up to Age of 19
On January 28, 2025, President Trump issued an Executive Order titled "Protecting Children from Chemical and Surgical Mutilation," directing agencies that provide research or education grants to medical institutions, including schools and hospitals, to take steps to stop providing gender-affirming services. The order further states that it is the "policy" of the United States that it will not "fund, sponsor, promote, assist or support the so-called 'transition' of a child [defined as an individual under the age of 19 years of age] from one sex to another" and indicates that the government will "rigorously enforce all laws that prohibit or limit these destructive and life-altering procedures." The order calls on HHS to take regulatory action to implement. It also directs the Department of Justice to pursue litigation and, among other things, to investigate and take action against entities that "may be misleading the public about long-term side effects" of gender-affirming care. Further, the order limits coverage of gender-affirming health care services under federally run insurance programs such as TRICARE.

Trump Administration Withdraws Proposed Menthol Cigarette Ban
The Trump administration withdrew a proposed ban on menthol-flavored cigarettes after President Joe Biden left office without finalizing the 2022 proposal. The 2009 Tobacco Control Act banned all flavors of cigarettes except menthol, and discussions over whether to add menthol to the ban have continued ever since.

NIH Reduction in Indirect Cost Payments
On February 7, 2025, the National Institutes of Health ("NIH") announced that it is reducing the amount of "indirect" medical research funding going to institutions, which will reportedly cut spending by $4 billion per year. Specifically, the NIH announced a limit of 15% of grants award for "indirect costs," which are defined as "facilities" and "administration" (i.e., associated costs such as buildings, equipment, and support staff). This represents a major reduction on what was previously allowed under the NIH grant system. The notice states that the new 15% indirect costs rate will be applied to all current grants for expenses from February 10, 2025, forward, and to all new grants issued. NIH states that it will not be applying this cap retroactively to the initial date of issuance of current grants to institutions of higher education, although it believes it would have the authority to do so under 45 CFR 75.414(c).

Trump Administration Issues Pause on Foreign Aid
On January 20, 2025, the Trump administration issued a 90-day pause on all foreign aid, which further prohibits aid from being "disbursed in a manner that is not fully aligned with the foreign policy of the President." Shortly thereafter, on February 23, 2025, the U.S. Agency for International Development placed direct hire personnel on administrative leave globally. These actions are reportedly impacting various global health initiatives and medical research projects.

DEA, HHS Delay Effective Dates of DEA Telemedicine Final Rules
On February 14, 2025, the Drug Enforcement Administration ("DEA") and HHS released a final rule delaying the effective dates of the Expansion of Buprenorphine Treatment via Telemedicine Encounter and Continuity of Care via Telemedicine for Veterans Affairs Patients final rules from February 18, 2025, to March 21, 2025 (further delayed until December 31, 2025, in a release on March 20, 2025), in accordance with the Regulatory Freeze Pending Review Presidential Memorandum. The new effective dates will not affect prescribing, due to the temporary extension of COVID-19 telemedicine prescribing flexibilities in place through the end of the year.

Trump Administration Halts Biden-Era Hospice Special Focus Plan
The Trump administration has "ceased" the implementation of a Biden-era Medicare program aimed at improving underperforming hospices, citing the need to "further evaluate the program." Under the Hospice Special Focus Program, select hospice providers were subject to enhanced oversight to monitor for and facilitate improvement. The program's enforcement actions included fines, suspended reimbursements, and potential termination from Medicare.

CMS Cuts Funding for ACA Signup Program
On February 14, 2025, CMS announced a reduction in funding for the Affordable Care Act ("ACA") Navigator program to $10 million. The reduction is based on data showing that Navigators—community groups that receive federal grants to educate consumers about ACA exchanges—received approximately $98 million in 2024 to enroll 92,000 individuals, translating to a cost of $1,061 per enrollment. A press release issued by CMS claimed: "Navigators are not enrolling nearly enough people to justify the substantial amount of federal dollars previously spent on the program."

President Trump Issues Executive Order to Lower Cost of IVF Treatments
On February 18, 2025, President Trump signed an Executive Order directing the Assistant to the President for Domestic Policy to, within 90 days, submit policy recommendations for protecting access to and reducing costs for in vitro fertilization, or IVF.

President Trump Issues Executive Order Concerning Health Care Price Transparency Rules
On February 25, 2025, President Trump issued an Executive Order to reinforce an Executive Order from his first term on health care pricing transparency. The previous June 2019 Executive Order directed HHS to issue regulations mandating that hospitals and health plans provide specific pricing information to patients. The new Executive Order requires agency action to implement and enforce the Hospital Price Transparency and Transparency in Coverage regulations that were implemented pursuant to the 2019 Executive Order. Within 90 days, it requires "disclosure of the actual prices of items and services, not estimates" and instructs government agencies to issue guidance or proposed regulations ensuring pricing information is standardized and easily comparable. 

HHS Rescinds Policy on Public Participation in Rulemaking
In a policy statement published on February 28, 2025, HHS announced its intention to discontinue the decades-long practice of allowing public notice and comments for certain agency actions.

CMS Notifies Hospitals of Intention to Update Polices for Gender-Affirming Care

On March 5, 2025, CMS sent a memorandum to hospitals nationwide reminding them of the "program requirements of hospitals to serve all patients, especially children, with dignity and adherence to the highest standard of care" in relation to the provision of gender-affirming care for youth. CMS indicated that it may soon take steps to "appropriately update its policies to protect children" given the purported "lack of medical evidence in support of" gender-affirming treatments.

HHS, FDA Announce Plan to Review Infant Formula
On March 18, 2025, HHS and FDA announced the launch of Operation Stork Speed to enhance the safety, quality, and nutritional adequacy of infant formula in the United States. The initiative includes increased testing for heavy metals and other contaminants, a comprehensive nutrient review, and efforts to encourage the development of new infant formulas. 

HHS Renews Public Health Emergency as Result of the Consequences of the Opioid Crisis
On March 18, 2025, HHS Secretary Robert F. Kennedy, Jr., renewed the public health emergency declaration addressing the nation's opioid crisis, allowing the administration to leverage expanded authorities to respond to the crisis, including through public-private sector coordination.

USDA Set to Solicit Proposals for Poultry Bird Flu Vaccine
On March 20, 2025, the United States Department of Agriculture ("USDA") announced an investment of up to $100 million in funding opportunities for the public and private sectors relating to the development of new poultry vaccines and virus detection methods that target the prevention and mitigation of bird flu. USDA announced it will prioritize proposals addressing novel therapeutics, improved diagnostics, risk pathways, biosecurity, and novel vaccines.

Read the full update here.