In this update:
- Administration Updates
- White House Replaces Covid-19 Informational Website With Lab Leak Theory
- U.S. Attorney Sends Letters to Medical Journals About Alleged Bias
- Federal Agencies
- NIH Stops Grants to Universities with DEI Policies or Israel Boycotts
- FDA Removes Pharma Representatives from Advisory Committees
- Other Updates
- Supreme Court Hears Oral Arguments in Preventive Care Case
- New York State Updates
- NYS Budget Deadline Continues to Be Pushed Back
- DOH Issues Proposed Regulations Amending the “12-Week Rule” for Foreign Medical Graduates and Limited Permit Allowances
Administration Updates
White House Replaces Covid-19 Informational Website With Lab Leak Theory
On April 18th, the Trump Administration replaced the main Covid-19 informational website, covid.gov, with a website arguing the merits of the lab leak theory. The website details the Wuhan Institute of Virology, with its history of gain-of-function research, and the potential spillover of infection from researchers to the broader Wuhan community. The website takes aim at a number of Trump adversaries including Dr. Anthony Fauci, the World Health Organization (WHO), and former Governor Andrew Cuomo. In late January, the Central Intelligence Agency (CIA) issued a new assessment pointing to the feasibility of a lab leak as the origin of Covid-19, as the Federal Bureau of Investigation (FBI) had previously done. Other intelligence agencies, though, rebuke the lab leak theory, claiming Covid-19 was likely transferred from animals to humans at an illegal wild animal market.
The website is available here.
U.S. Attorney Sends Letters to Medical Journals About Alleged Bias
Over the past week, at least two medical journals—CHEST and the New England Journal of Medicine (NEJM)—have received letters from the interim U.S. Attorney for the District of Columbia, who has close ties to President Trump, asking six questions about alleged bias in their decisions to publish certain content. The letters reference fraud regulation and postal codes, both prosecutable offenses, though no actual offenses are noted. In its response, the NEJM stated: “We use rigorous peer review and editorial processes to ensure the objectivity and reliability of the research we publish. We support the editorial independence of medical journals and their First Amendment rights to free expression. The Journal actively fosters scholarly scientific dialogue and remains steadfast in its commitment to supporting authors, readers, and patients.”
Federal Agencies
NIH Stops Grants to Universities with DEI Policies or Israel Boycotts
On April 21st, the National Institutes of Health (NIH) released new terms and conditions for research grants. Moving forward, NIH fund recipients must certify that they do not have any diversity, equity, inclusion, and/or accessibility programming that could violate anti-discrimination laws. Additionally, recipients must affirm that they do not participate in boycotts of Israeli companies or firms doing business in Israel. In the case of terms violation, the NIH may terminate the award and claw back disbursed funding. This policy change is effective immediately, applying to new grants, renewals, and continuation awards; it also aligns the NIH with a recent, similar Department of Health and Human Services (HHS) grants policy statement that excluded NIH grants. This move tests the statutory reach of the NIH, which traditionally does not have a say in how funded research is conducted, so long as it is legal and ethical.
The new terms and conditions are available here.
FDA Removes Pharma Representatives from Advisory Committees
On April 17th, the Food and Drug Administration (FDA) announced that it will remove pharmaceutical industry representatives from advisory committees, replacing them with patients and caregivers “whenever statutorily possible.” Per the FDA Modernization Act of 1997, the FDA is required to have non-voting industry representatives on advisory panels, with certain ethics guardrails to limit conflicts of interest. Former Commissioner Robert Califf commented on the limited scope of this move, given that industry representatives do not vote. Further, the FDA is not required to follow the recommendations of advisory committees, though according to a study of 400 verdicts, the agency follows their recommendations 88% of the time.
Other Updates
Supreme Court Hears Oral Arguments in Preventive Care Case
On April 21st, the Supreme Court heard oral arguments in Braidwood v Health and Human Services. Press reports suggest the high court appeared inclined to uphold the requirement that health insurers and employers cover preventive items and services recommended by the United States Preventive Services Task Force (USPSTF) even though its members are not Senate-confirmed. The justices appeared to favor the government’s position that the USPSTF is not entirely independent because the HHS Secretary retains a supervisory role over the otherwise independent task force, whose recommendations have a legal effect only if the HHS Secretary allows them to become final. This argument from the Trump administration suggests even a ruling from the Court to uphold ACA coverage of items and services recommended by the USPSTF could cause changes to insurance coverage requirements if the HHS Secretary determines some recommended items and services should not be covered. A ruling is expected by the end of the Court’s current term in June, and some justices appeared to suggest the case could be returned to a lower court.
New York State Updates
NYS Budget Deadline Continues to Be Pushed Back
Negotiations between the Executive, Assembly, and Senate over the New York State Fiscal Year (FY) 2025-26 Budget are continuing, requiring ongoing extensions of the statutory April 1st deadline. Lawmakers have passed an eighth budget extender, ensuring the government remains funded through April 29th.
DOH Issues Proposed Regulations Amending the “12-Week Rule” for Foreign Medical Graduates and Limited Permit Allowances
On April 23rd, the New York State (NYS) Department of Health (DOH) issued a proposed amendment to section 405.4 of Title 10 of the New York Codes, Rules, and Regulations (NYCRR) that would change the “12-week rule” for foreign medical school graduates and limited permit allowances for all graduates. Currently, if a foreign medical graduate’s clinical clerkship exceeds 12 weeks, the clerkship must be at one of 17 schools pre-approved by the State Education Department (SED). The proposed amendment would provide an additional pathway for foreign medical graduates, allowing them to qualify if they complete a post-graduate training program approved by the Accreditation Council for Graduate Medical Education (ACGME) or the American Osteopathic Association (AOA) and are eligible for a fellowship, even if their extended clerkships were not at an SED-approved site.
The proposed rule would also allow limited permit holders (both U.S. and foreign-trained) directly employed by a public hospital to practice without the currently required extra residency years, provided they are supervised by a NYS-licensed physician credentialed by the hospital. DOH intends for these amendments to “ease physician staffing shortages in hospitals, with guardrails to ensure that physicians educated outside of the U.S. still meet an appropriate education and oversight bar.”
The proposed regulations are available here. Public comment may be submitted to regsqna@health.ny.gov through June 23rd.