Food and Drug Administration

Trump may fire FDA chief Marty Makary, reports say

May 8 (UPI) — President Donald Trump intends to fire Food and Drug Administration Commissioner Marty Makary because he is frustrated with the agency.

Trump signed off on the decision to replace Makary as he has clashed with Trump, officials in the Department of Health and Human Services and other officials in the administration, multiple reports said on Friday.

The reports — from NBC News, The New York Times, The Wall Street Journal and The Washington Post — all were attributed to Trump administration sources who requested anonymity because they were not authorized to comment on the issue.

Makary, a former surgeon at Johns Hopkins, was confirmed to run the FDA in March 2025 on a vote the included two Democratic members of the Senate voting yes.

His nomination carried some controversy because, like several other Trump cabinet members and nominees, is a former Fox News contributor who preferred that society develop natural immunity to the virus that causes COVID-19 instead of the CDC’s preferred method of using vaccine-induced immunity during the pandemic.

The reports suggest that Makary has struggled to run the FDA as long-time staff have left the agency and a range of healthcare, pharmaceutical and advocacy groups have been highly critical of its actions.

The Department of Health and Human Services and Makary have not commented on the reports, and sources for all four news organizations noted that the plan could change if Trump changes his mind.

President Donald Trump delivers remarks at an event he is hosting for a group that includes Gold Star Mothers and Angel Mothers in honor of Mother’s Day in the Rose Garden of the White House on Friday. Photo by Aaron Schwartz/UPI | License Photo

Source link

Abortion pill maker asks Supreme Court to pause telehealth prescription block

May 2 (UPI) — A company that makes the abortion drug mifepristone on Saturday asked the U.S. Supreme Court to immediately pause a ruling that prevents doctors from prescribing it during telehealth visits.

Late Friday, a three judge panel on the 5th Circuit Court of Appeals unanimously ruled in favor of the state of Louisiana in a case asking the court to block doctors from prescribing the drug in telehealth visits.

Louisiana in the last four years has moved to prevent women in the state from obtaining abortion care legislators there were among the first to ban abortion after the repeal of Roe v. Wade, and later blocked doctors from prescribing the medical abortion pill in virtual telehealth visits.

The company, which is not the only drugmaker planning to file an appeal, said that patients will be stuck in limbo because of the lack of clarity it leaves for legal use of the drug, NBC News and Politico reported.

Roughly half of all abortions in the United States are performed using medications.

“Danco has been free to rely on procedures set by the FDA to distribute its product,” lawyers for the company said in a filing with the court.

“The Fifth Circuit’s decision immediately ends that,” the lawyers said. “A stay should issue to prevent the disruption and confusion that will result if the decision below were to remain operative.”

In addition to Danco, Politico reported that GenBioPro, which also manufactures the drug, has indicated that it will also file an appeal with the court.

Mifepristone was approved by the U.S. Food and Drug Administration in 2000 for medical termination of pregnancy and, until the COVID-19 pandemic, could only be prescribed during in-person appointments.

Early in the pandemic and the country locked down in an effort to stem the spread of the virus, doctors sued the FDA to allow them to prescribe mifepristone during telehealth visits.

The FDA temporarily changed the rule, but in 2023 adopted it permanently as some states started to restrict access to abortion and abortion services after the Supreme Court struck down Roe v. Wade.

Pharmaceutical companies and patient advocates warned that the restriction circumvents the FDA’s regulatory authority, which is based on evidence and data, and that it may offer a path for people to challenge other medications based on personal interest or opinion.

In the case of Danco, it also immediately filed the appeal because it is the only product it makes and “without a valid legal framework for distributing that product, Danco will lose its only source of revenue and may be unable to continue operating.”

President Donald Trump signs a series of executive orders in the Oval Office of the White House on Thursday. Trump signed an order to expand workers’ access to retirement accounts. Trump also signed legislation ending a 75-day partial shutdown of the Department of Homeland Security after the House voted in favor of funding. Photo by Aaron Schwartz/UPI | License Photo

Source link

Court blocks abortion pills prescribed through the mail

A federal appeals court on Friday night blocked the nationwide sale of mifepristone, also known as the abortion pill, after the state of Louisiana sued the federal government for allowing it to be sold during telehealth appointments and mailed to patients. File Photo by Bill Greenblatt/UPI | License Photo

May 1 (UPI) — A federal appeals court on Friday night issued a ruling that enacts a nationwide block on the prescription of the abortion pills in telehealth appointments and mailing them to patients.

A three-judge panel on the 5th Circuit Court of Appeals ruled in favor of the state of Louisiana, which had used to end a Food and Drug Administration rule that allows doctors to prescribe mifepristone without having an in-person visit, ABC News, Politico and The New York Times reported.

Mifepristone was first approved by the FDA in 2000 for medical termination of pregnancy, and until the COVID-19 global pandemic required that the drug be prescribed to patients during in-person doctor’s appointments.

After enacting a strict abortion ban in 2022, Louisiana then moved to reclassify mifepristone as a controlled substance and criminalized its possession, effectively making it illegal in the state.

Although Louisiana had made it illegal to prescribe or possess in the state, people could obtain prescriptions from out-of-state doctors have virtual telehealth visits, with the mails mailed to people’s homes.

As the COVID-19 pandemic spread across the country in spring 2020 and forced much of in-person life to stop, doctors sued the FDA for an exception to the in-person requirement to prescribe mifepristone.

The agency in 2021 announced that it would exercise “enforcement discretion” because of the COVID-19 public health emergency.

After Roe v. Wade was struck down by the U.S. Supreme Court, several states across the country moved to outlaw most abortions, but mifepristone continued to be available through telehealth appointments and the mail.

Louisiana told the court that it needed relief because of an alleged influx of abortion pills to the state, making the argument that mail-delivered abortion pills endanger the safety of women there.

“We are alarmed by this Court’s decision to ignore the FDA’s rigorous science and decades of safe use of mifepristone in a case pursued by extremist abortion opponents,” Evan Masingill, CEO of GenBioPort, which manufacturers the drug, told Politico in a statement.

“We remain committed to taking any actions necessary to make mifepristone available and remain accessible to as many people as possible,” Masingill said.

Source link

Trump promotes new drug price deal with Regeneron

April 23 (UPI) — On Thursday, President Donald Trump announced a new drug price deal with Regeneron, the latest to agree to the “most favored nation” price policy the White House has pushed since last year.

The price deals involve voluntary price cuts by manufacturers for drugs sold to the public and the government through the TrumpRx website. In return, the manufacturers get breaks on Trump’s tariffs and other perks.

In addition, Regeneron also announced Thursday that the Federal Food and Drug Administration has approved Otarmeni, a gene therapy for genetic hearing loss. The company said the therapy would be available free in the United States.

The company is the last of the 17 the administration sought for the price policy, but officials said that more will follow. Smaller companies may also look to make deals.

“It’s not the finish line,” said Chris Klomp of the Department of Health and Human Services, who was chief negotiator on the deals, the Washington Post reported.

For the most part, the discounts do not affect people with private insurance or those on Medicaid, Axios reported. They do affect Medicaid drug prices and those buying through the TrumpRx website.

Trump called the program “the biggest price reduction in drugs in history.”

However, some have said the prices are higher through TrumpRx than through other sources, the Washington Post reported. Some lawmakers also are calling for the confidential terms of the agreements to be released, a subject that came up in hearings this week with Health and Human Service Secretary Robert F. Kennedy Jr, who has not committed to such a release.

Source link

Trump signs order to speed research on psychedelics for mental health

April 18 (UPI) — President Donald Trump signed an executive order Saturday to accelerate research for some psychedelic drugs to treat mental health disorders.

Surrounded by podcaster Joe Rogan and veterans, the president signed the order that could lead to use of the psychedelics in controlled, therapeutic settings.

“We’re taking this decision, this decisive step, to confront one of the most urgent public health challenges facing our nation, the mental health crisis,” Trump said Saturday in the Oval Office.

“Today’s order will ensure that people suffering from debilitating symptoms might finally have a chance to reclaim their lives and lead a happier life,” Trump said.

The order directs the Food and Drug Administration to speed its review of new treatments. Trump said the order applies to certain drugs that are already in the “advanced stages of clinical trials.”

Rogan said he sent the president “some information” about the drugs after he heard about them on his podcast, The Hill reported.

“I sent him that information. The text message that came back: ‘Sounds great. Do you want FDA approval? Let’s do it.’ Literally that quick,” Rogan said.

Trump mentioned ibogaine, which has been used to treat post-traumatic stress disorder in other countries. He said the administration would be “opening the pathway” for the drug to be included in the Right to Try Act, which allows terminally ill patients to participate in clinical trials for treatments still under FDA review, The Hill reported. Trump signed that act into law in 2018.

“Under this new program in this administration, drugs can get approved in weeks, not a year or year plus, but in weeks, if they are in line with our national priorities,” FDA Commissioner Martin Makary said at the signing.

“This is an unmet public health need, and there are potentially promising treatments,” Makary said. “That’s why there’s a sense of urgency around this. That’s why we’re doing it now.”

In 2024, 471 U.S. service members died by suicide, and there were 1,515 attempts reported, according to the Pentagon’s Annual Report on Suicide in the Military.

Some of the drugs included are ibogaine; LSD; psilocybin; known as magic mushrooms; and MDMA, known as ecstasy. Trump added that the government had just committed $50 million in additional funding for ibogaine research, The Post reported.

“Federal prohibition of psychedelic medicine in America is over,” said W. Bryan Hubbard, an advocate for access to ibogaine, The Washington Post reported.

Kevin Sabet, who was a White House drug policy adviser over three presidential administrations, disagreed. He said the order will “send the wrong message” and encourages hasty, potentially dangerous research.

“People need to realize there is little to no evidence for most of these drugs and most of the conditions they claim to alleviate,” Sabet, president of Smart Approaches to Marijuana, wrote in a text message to The Post.

Health and Human Services Secretary Robert F. Kennedy Jr. has championed the idea of using psychedelics to help with mental health conditions. On Saturday, he said officials owed it to veterans “to turn over every stone.”

“It’s disturbing to me and to the president that hundreds, in fact, thousands of veterans are having to travel to Mexico or other countries to experiment with interventions that hold great promise,” Kennedy said.

Source link

RFK Jr. defends decisions at HHS in congressional testimony

Secretary of Health and Human Services Robert F. Kennedy, Jr. speaks during a House Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies, one of seven congressional committees he testified before Thursday. Photo by Bonnie Cash/UPI | License Photo

April 16 (UPI) — Health and Human Services Secretary Robert F. Kennedy, Jr. on Thursday testified before seven congressional committees, often clashing with Democrats about decisions he has made about vaccines and department priorities.

The testimony is Kennedy’s first trip to the Capitol this year and the first time that he has appeared before Congress in more than seven months, The Washington Post reported.

In addition to unilaterally remaking the Center for Disease Control and Prevention’s vaccine advisory committee and the agency’s recommended childhood vaccine schedule — which were blocked by a federal judge in March — he has changed the Food and Drug Administration‘s recommendations on diet and shepherded medications through federal approval processes while allegedly ignoring data on them.

Kennedy also was asked by members of Congress about the Trump administration’s 12.5% budget request decrease, which amounts to about $16 billion that it sought for its fiscal year 2027 budget proposal, NPR reported.

“Our children are the sickest generation in modern history — decades of failed policy, captured agencies and profit-driven systems have caused it,” Kennedy said during a hearing before the House Ways and Means Committee.

“Parents across this country demanded change — and we are delivering it,” he said.

Kennedy said that the measles vaccine “certainly” could have saved the life of a child who died in Texas last year during an outbreak in the state.

More than 1,700 measles cases have been reported through the first 3 1/2 months of 2026, compared to more than 2,200 reported in all of 2025.

He also was asked by Rep. Linda Sanchez, D-Calif., about ending an influenza vaccine public awareness campaign while investing money in marketing efforts for his remade food pyramid.

“You suspended this pro-vaccine messaging campaign, but somehow you’re spending taxpayer dollars to drink milk, shirtless in a hot tub with Kid Rock?” Sanchez asked.

Kennedy also was accused of “diminishing science” by Rep. Bradley Scott, D-Ill., with his support for $5.7 billion in cuts to the National Institutes of Health meant for drug development.

“Nobody wants to make the cuts,” Kennedy said in response to several questions about reducing the HHS budget, but said the nation needs “to tighten our belt” because of the national debt, which he blamed on Congress.

First lady Melania Trump speaks during a House Ways and Means Committee roundtable discussion on protecting children in America’s foster care system in the Longworth House Office Building near the U.S. Capitol on Wednesday. The bipartisan group of lawmakers are looking to address challenges children in foster care face, including barriers to education and educational advocacy, housing, employment opportunities, financial independence, and technology. Photo by Bonnie Cash/UPI | License Photo

Source link