Executive Orders and Actions on Health Care

The Trump Administration seeks to speed up FDA reviews, lower drug prices, and increase domestic pharmaceutical manufacturing, amid vaccine denial and fictional studies.

Whether by Executive Order or by agency actions, changes to American healthcare are starting to materialize, from updates to COVID vaccine guidelines that exclude pregnant women to the “MAHA” report’s inclusion of AI-generated fictional studies which will be used to inform policy recommendations later this year. The Trump Administration also seeks to speed up FDA reviews, lower prescription drug prices, and eliminate regulations which limit domestic pharmaceutical manufacturing.

The Guardian reports that Veterans Affairs (VA) bylaws have been updated to permit the denial of medical care based on marital status and political affiliation of patients, citing Trump’s day-one executive order on gender ideology. However, it’s unclear how widespread these changes are, since VA hospitals write their bylaws individually. The changes reported do not mandate this type of discrimination, and denials of this nature are certain to provoke judicial scrutiny if veteran care is impacted.

In June, RFK Jr “retired” the entire Advisory Committee on Immunization Practices (ACIP), and replaced them with vaccine deniers. Among the new hires is Vicky Pebsworth, who has served as a board member for the National Vaccine Information Center, a major contributor to vaccine misinformation. ACIP is responsible for advising the CDC on how to recommend vaccines: who should get which vaccines, and when. The group announced at their first meeting on June 25 that they would be evaluating the effect of the vaccine schedule for children. The American Academy of Pediatrics, in response, announced that they would no longer rely on ACIP recommendations for its own vaccine schedule.

Vaccine booster approvals are facing new requirements for clinical trials which could prevent an up-to-date COVID booster from hitting the market in time to be most effective. At the same time, the FDA announced on June 17 that it would implement a program to review some new medicines within two months, a big shift from the ten month standard. They will be issuing vouchers to companies which they determine are “aligned with U.S. national priorities” to allow those companies to submit their medications for faster review without altering their review standards. Criteria for eligibility for this program have not been published and are unclear. This announcement comes on the heels of the introduction of Elsa, the FDA’s new AI chatbot which officials have stated they will use to increase efficiency in the agency. But Elsa, according to FDA employees, produces false information and needs to be checked thoroughly, which undermines the stated goal of efficiency.

A few executive orders have gone relatively unnoticed which could have effects on our healthcare and medical system. Many of them request reports or actions later this year.

Prescription Drug Pricing

An order signed in February called for a “more competitive, innovative, affordable, and higher quality healthcare system” by improving pricing transparency and standardization. This builds on an executive order Trump signed in 2019 which required hospitals to provide pricing information for hundreds of services in a consumer-friendly way. The new order goes a step further to require hospitals to disclose actual prices rather than estimates, as well as calling for a standardization of pricing to make it easier for consumers to compare between competitors. The Center for Medicare and Medicaid Services has issued new directives for hospitals and health providers, encouraging compliance with this executive order and requesting public input to improve compliance and enforcement.

In April, Trump signed an executive order which included several proposals for lowering drug prices with few specifics for how those proposals might be brought to life. Some of these include:

• the conditioning of grants for health centers on a practice to make insulin and EpiPens available at or below cost for certain patients,

• expansion of the program which allows states to import prescription drugs from countries with lower costs,

• changes to the payment model by which Medicare covers prescription drugs, and

• coordination with Congress to make specific changes to the Inflation Reduction Act which is the law passed under Biden in part to allow Medicaid to negotiate prices for certain drugs.

This executive order also calls for a joint effort between agencies to issue a report with recommendations to address anti-competitive behavior from pharmaceutical manufacturers, and another report with recommendations to accelerate approval of generic medications and improve the process of reclassifying drugs as over-the-counter. Both of these reports should be provided to the President before October 12.

In an executive order signed in May, Trump instructed the Department of Health and Human Services (HHS) to develop a most-favored-nation pricing strategy by June 12 which would allow American consumers to pay similar prices to what people in other advanced countries pay for prescription drugs. No plan has been published as of this writing but following the publication of a plan, HHS would communicate that strategy with the pharmaceutical companies and request that they comply voluntarily. If the companies don’t comply, HHS would need to propose a rulemaking plan to impose the strategy on those companies, although it is unclear what authority HHS has for establishing such a plan. Other methods of enforcement detailed in the executive order include:

• the Federal Trade Commission enforcing anti-competition laws,

• the Food and Drug Administration modifying or revoking the approval of drugs which are being “improperly marketed”,

• expansion of imports from countries with lower drug prices,

• the leveraging of exports of drugs or drug ingredients.

This order also directs HHS to facilitate direct-to-consumer purchasing programs by pharmaceutical companies. Currently, these companies sell their products to distributors, who then sell them to pharmacies for consumer purchase. The recommendation would cut out the middle-men. This follows a recent trend of pharmaceutical companies launching telehealth programs where they employ medical professionals to prescribe and sell their drugs directly to consumers (convenient, but with potential conflicts of interest).

Domestic Pharmaceutical Manufacturing

Meanwhile, another executive order signed in May purports to eliminate barriers to pharmaceutical manufacturing in the U.S. by streamlining the regulatory process. Over the last few decades, pharmaceutical companies have been moving their manufacturing operations to countries with better tax benefits and more lax environmental requirements. This order requires that by August 3, the FDA Commissioner must improve the process of U.S. review of pharmaceutical manufacturers overseas and publish the number of annual inspections. By November 1, HHS and EPA are instructed to review regulations around pharmaceutical manufacturing and take steps to eliminate what they deem redundant or unnecessary requirements and determine whether any nation-wide permits are necessary to stimulate domestic manufacturing.