Policy Watch: FDA moves to implement Trump order on psychedelic drugs

FDA fast-tracks psychedelics after Trump order

In an executive order issued last weekend, President Donald J. Trump directed the US Food and Drug Administration and the Advanced Research Projects Agency for Health (ARPA-H) to speed up the research and development of psychedelics, including psilocybin and ibogaine.

The FDA responded today by issuing Commissioner’s National Priority Vouchers—awards that speed up the timeline of recipients’ FDA review—to three companies developing, respectively, psilocybin for treatment-resistant depression, psilocybin for major depressive disorder, and methylone for post-traumatic stress disorder (PTSD). The agency is likely to issue additional vouchers for psychedelic drug candidates that have already received Breakthrough Therapy designation, which grants recipients speedier reviews and more organizational support from the FDA.

The FDA has not elaborated on which three companies received the vouchers. But in a press release, Compass Pathways said it had received one of the vouchers for its drug candidate COMP360, a synthetic formulation of psilocybin. Endpoints News reported that Transcend Therapeutics and the Usona Institute were the other two voucher recipients. A voucher does not necessarily serve as a rubber stamp for the drug candidates that qualify: the FDA rejected an early voucher recipient from a fast-track approval pathway in February.

The FDA has also green-lit a clinic trial for noribogaine, a derivative of ibogaine, a psychoactive indole alkaloid derived from the African Tabernanthe iboga shrub, to test its ability to treat alcohol use disorder.

“There is a growing recognition of the potential of psychedelic medications to address multiple different psychiatric conditions that are notoriously difficult to treat,” Tracy Beth Høeg, acting director of the FDA Center for Drug Evaluation and Research, says in a statement accompanying the announcement.

Meanwhile, the White House order also directs the Department of Health and Human Services (HHS) to give $50 million to ARPA-H for new investments in psychedelics. And it orders the HHS, FDA, and US Attorney General to collaborate to get patients access to new psychedelics as quickly as possible.

The order makes good on an early promise from HHS secretary Robert F. Kennedy Jr., who previously derided the FDA for its “aggressive suppression of psychedelics.” And as expected, it’s been well received by psychedelic-drug developers. “We are honored and grateful to be selected for the [voucher,] which is a clear validation of both the urgent unmet need facing millions of people living with treatment resistant depression and the innovative science of COMP360,” Compass CEO Kabir Nath says in the press release.

—Rowan Walrath

West Virginia chemical accident kills 2; US Chemical Safety Board to investigate

Two workers were killed and another seriously injured in a chemical accident at a silver recovery facility in Nitro, West Virginia. The accident led to the release of hydrogen sulfide and other chemicals, according to Kanawha County officials, speaking at a quickly called briefing on April 22, the day of the accident.

The incident occurred at the Catalyst Refiners plant, which recovers silver and conducts refining operations for silver and ethylene oxide catalysts and is owned by Ames Goldsmith. The company did not respond to a request for comment by publication time.

Local officials estimate some 30 people were exposed to the leak and sought treatment at a local hospital, including seven emergency responders. The officials added that the accident site is a small “warehouse-like” facility.

Officials also noted that members of the community outside the facility were not affected although a shelter-in-place order was issued for people within a 1.6 km (1 mile) radius of the facility. CW Sigman, the county director of emergency management, described an initial explosion, involving the mixture of nitric acid and other chemicals, that preceded the chemical leak. The explosion occurred during a tank-cleanup and shutdown operation that took place in an area occupied by other employees.

County officials said the incident was under investigation by several state and federal agencies, including the US Chemical Safety and Hazard Investigation Board, which has sent investigators to the accident site.

—Jeff Johnson, special to C&EN

New York legislators pass food chemical bill to close GRAS loophole

New York state assemblymembers approved the Food Safety and Chemical Disclosure Act on April 21. The bill had previously passed the state senate in March, and it will now be delivered to Governor Kathy Hochul (D) to sign into law.

The legislation requires companies selling food products in New York state to submit safety assessments for generally recognized as safe (GRAS) ingredients to the New York Department of Agriculture and Markets to publish in an online database.

The GRAS pathway allows companies to introduce new food ingredients to the market without review from the US Food and Drug Administration, by self-affirming that the ingredients are already recognized as safe. A proposed federal rule to overhaul the GRAS system is currently under review at the White House Office of Information and Regulatory Affairs, with a draft expected to be published sometime this spring or early summer.

“New York is stepping up where Washington has slowed down,” says Jessica Hernandez, legislative director at the Environmental Working Group, in a written statement.

“Since processed foods are produced and distributed nationally, we hope and expect that the public disclosure required by this legislation will reverberate across the United States,” says Brian Kavanagh, the bill’s chief sponsor in the state senate, in a written statement.

The new legislation also bans sales in the state of food containing the chemicals red no. 3, potassium bromate, or propylparaben. The use of red no. 3 in food was banned nationally in January 2025, shortly after this New York bill was introduced.

—Delger Erdenesanaa

House science committee Republicans question National Academies’ climate work

The chair of the US House of Representatives Committee on Science, Space, and Technology (SST), along with two of its subcommittee chairs, last week requested information from the National Academies of Sciences, Engineering, and Medicine (NASEM) with regard to some of the academies’ climate science committees and actions.

In an April 17 letter to NASEM president Marcia McNutt, SST chairman Brian Babin (R–TX), Investigations and Oversight Subcommittee Chairman Rich McCormick (R–GA), and Environment Subcommittee chairman Scott Franklin (R–FL) question whether the academies’ climate report, “Anthropogenic Greenhouse Gases and US Climate: Evidence and Impacts,” was balanced, transparent, and independent.

NASEM produced the review in response to the US Environmental Protection Agency’s proposal to rescind its 2009 climate endangerment finding on a short time scale. EPA administrator Lee Zeldin announced the agency’s intent to rescind the endangerment finding July 29. NASEM had assembled a group of scientists to review the most recent climate science on Aug. 7; it released the report on Sept. 17.

“In addition to the markedly compressed timeline of the report’s publication, questions also surround the Greenhouse Gases Committee’s composition, objectivity, and funding,” the chairmen say in the letter (PDF).

On April 21, the chairmen sent another letter to McNutt, this time asking for information on NASEM’s Attribution Committee, which examines the connections between extreme weather and climate change. The chairmen say (PDF) they see “a troubling pattern” in which committee members who lead the review of “the alleged human causes of climate change, are affiliated with nonprofits that support climate accountability lawsuits, raising the appearance of impropriety and member bias.”

The chairmen are asking for many records by early May, including those pertaining to the work and member selection process of both NASEM committees, the academies’ communications with federal agencies and funding sources, and broader data on NASEM’s funding and study practices.

“We look forward to building on our longstanding relationship with the House Committee on Science, Space, and Technology to address the issues they have raised,” NASEM spokesperson William Kearney told C&EN by email.

—Leigh Krietsch Boerner

Proposed NSF and NIH budgets would yield $35 billion economic loss, report finds

The Science and Community Impacts Mapping Project (SCIMaP), a team of researchers who track the impact of federal investment in science, released two reports Thursday finding that the Donald J. Trump administration’s proposed budget cuts for the US National Science Foundation (NSF) and the National Institutes of Health (NIH) would result in $35 billion of reduced economic activity and 150,000 jobs lost across the country.

On April 3, the Trump administration released its fiscal year (FY) 2027 budget request, which called for cutting the NSF’s budget by 54.5% and the NIH’s by 10.5%.

SCIMaP’s estimates are based, in part, on a recent report by the NSF (PDF) that found that every dollar of federal funding that is spent in the US on research and development generates $2.64 in economic activity. An analysis from United for Medical Research, a coalition of research institutions that advocate for increased funding for the NIH, puts that number at $2.57 for every dollar invested in this agency’s research, specifically.

Using these figures, along with the administration’s proposed FY 2027 budget for the two agencies and previous inflation-adjusted budgets, SCIMaP calculates that a 54.5% reduction in funding for the NSF would result in a loss of $16.9 billion in economic activity and 90,000 jobs (PDF), while the proposed cuts to the NIH’s budget would result in $18 billion in lost economic activity and 60,000 lost jobs (PDF).

The economic impacts would be felt throughout the US, but some areas would be affected more than others. The states most affected by these cuts would be California, New York, Massachusetts, Texas, and Pennsylvania.

In addition, “rural communities and areas with many people employed in medicine or higher education face disproportionate economic and job losses,” says Alyssa Sinclair, the project’s colead and a postdoctoral fellow at the University of Pennsylvania, in a press release published with the reports.

Congress has already begun working on the FY 2027 appropriations bills. Last year, it largely rejected the Trump administration’s proposed cuts to science agencies.

The White House did not respond to C&EN’s request for comment in time for publication.

—Krystal Vasquez