medication

WASHINGTON — The Supreme Court took a first step on Monday to consider anti-abortion challenges to medication that has been commonly used to end early pregnancies for 25 years.

The justices moved quickly to put on hold an appeals court ruling that would block the mailing of abortion pills nationwide. Justice Samuel A. Alito issued a temporary “administrative stay” until May 11.

Three years ago, the court blocked a similar challenge to abortion pills, ruling that anti-abortion doctors had no grounds to sue over medication they did not use or prescribe.

Last year, Louisiana’s state lawyers sued and argued their state ban on abortions is thwarted if women can receive abortion pills through the mail after consulting a doctor online.

They questioned the federal regulation that permits doctors to prescribe the medication without seeing patients in person.

On Friday evening, the conservative U.S. 5th Circuit Court of Appeals in New Orleans jolted abortion rights advocates, first by ruling this claim is likely to succeed and then by putting their order into effect immediately.

Judge Kyle Duncan, a President Trump appointee, said the Food and Drug Administration had “failed to adequately study whether remotely prescribing mifepristone is safe.”

Moreover, women may suffer “irreparable harm” if these mail-order prescriptions are allowed to continue, he said.

If upheld, the order would go far beyond Louisiana and make it illegal for women in California and other states to obtain the pills through a pharmacy or by mail if they did not see a doctor first.

The legal dispute may put the Trump administration in an uncomfortable spot. In response to the abortion critics, the FDA agreed to review the safety of prescribing these commonly used pills without a required trip to a doctor’s office.

Its review is not likely to be completed until after the November elections.

The 5th Circuit judges said they were not prepared to wait for the outcome of that review.

On Saturday, two makers of mifepristone — Danco Laboratories and GenBioPro — filed emergency appeals asking the justices to block the 5th Circuit’s order.

“Never before has a federal court” rejected a long-standing drug approval by the FDA, they said, and restricted its distribution based on claims the agency had rejected.

The justices asked for a response from Louisiana by Thursday.

Mifepristone was approved in 2000 as a safe and effective way to an early pregnancy. It is typically used in combination with a second drug — misoprostol — which is not affected by the court’s decision.

If mifepristone becomes unavailable, women may use misoprostol alone, abortion rights advocates say.

In recent years, the majority of abortions in this country result from the use of medication.

Alito is responsible for emergency appeals from the 5th Circuit, and Monday’s order does not signal what the court will decide.

“This ruling is not final — keep watching,” said Nancy Northup, president of the Center for Reproductive Rights. “Getting abortion pills through telehealth has been a lifeline for women since Roe v. Wade was overturned. Louisiana’s attempt to restrict access is political and not based in science or medicine. Americans deserve access to this critical drug that has been FDA approved for 25 years.”

Carol Tobias, president of National Right to Life, agreed the court’s order did not resolve anything.

“It is a temporary procedural step that leaves unresolved the very real concerns about the safety of these drugs and the decision under the Biden administration’s FDA to recklessly remove longstanding safeguards,” she said.

California Atty. Gen. Rob Bonta joined with 21 other state attorneys in urging the court to block the 5th Circuit’s decision.

“Telehealth has made it easier for women — especially in rural, low-income, and underserved communities — to access mifepristone and obtain reproductive health care,” he said. “We should be guided by science, not politics. The in-person dispensing requirement was eliminated because it was medically unnecessary, and there is still no basis for reinstating it.”

WASHINGTON — The Food and Drug Administration will hold a meeting in the summer to consider easing restrictions on more than a half-dozen peptide injections, a group of unapproved therapies that have become popular among wellness influencers, fitness gurus and celebrities.

The meeting announcement Wednesday follows repeated pledges by Health Secretary Robert F. Kennedy Jr. to loosen regulations on peptides, which are often pitched as a quick way to build muscle, heal injuries or appear younger. There’s little research behind those claims and most peptides have not been reviewed for safety by the FDA.

Kennedy has discussed using peptides for his own injuries. And some major supporters of his Make America Healthy Again movement are big proponents of them, including Gary Brecka, a self-described “longevity expert” who sells various peptide formulas through his website.

The FDA said in a federal notice Wednesday that it will ask a panel of outside advisors to review seven peptides at a meeting in July, specifically whether they should be added to a list of substances that can be safely produced by pharmacies. In the meantime, the agency said it would soon remove the chemicals from a restrictive list reserved for unapproved, high-risk drugs. The peptides under discussion include some of the most popular among influencers, such as BPC-157, which is marketed to heal injuries and reduce inflammation.

“The Wild West is about to become wilder,” said Dr. Peter Lurie, a former FDA official who now leads the Center for Science in the Public Interest. In an interview, Lurie said allowing peptides on the market without clinical testing poses a “profound threat” to FDA’s decades-old system for vetting drugs.

“I don’t see why one would take the path of a proper drug approval if there is now this less rigorous, alternative path to market,” he said.

Under President Biden, the FDA added nearly 20 peptides to the federal list of substances that should not be produced by compounding pharmacies — businesses that mix medications that aren’t available from drugmakers.

At the time, the FDA’s panel of pharmacy advisors voted overwhelmingly that the peptides did not meet the criteria for substances that can be safely compounded. And FDA regulators agreed, saying later that the substances “present significant safety risks,” because most have not been extensively tested in humans.

Many of the FDA advisors and internal staff who oversaw those decisions no longer work for the agency. The FDA’s pharmacy panel currently has a number of vacancies, which Kennedy could fill before the July meeting.

Kennedy previewed Wednesday’s move in an interview with podcast host Joe Rogan. Both men have repeatedly spoken about peptides and claimed to have benefited from their use.

RFK Jr. claims personal benefit from peptides

“I’m a big fan of peptides,” Kennedy told Rogan. “I’ve used them myself and with really good effect on a couple of injuries.”

Given Kennedy’s statements, Lurie said it was doubtful the drugs would receive real scrutiny from FDA.

“Everybody knows the outcome that the secretary wants,” Lurie said. “I don’t believe for one moment that what’s going on here is an honest investigation of whether these products should be compounded.”

Scott Brunner of the Alliance for Pharmacy Compounding said the coming meeting will be the start of a “protracted process.” Even if the panel votes to make the peptides available, and the FDA agrees, the agency will still have to draft and publish rules on the change, he noted.

Peptides are essentially the building blocks of more complex proteins. Inside the human body, peptides trigger hormones needed for growth, metabolism and healing.

In recent years peptides have become widely known through the blockbuster success of GLP-1 medications, which the FDA has approved for treating obesity and diabetes. Other FDA-approved peptides include insulin for diabetics and hormone-based drugs for several medical conditions.

But many of the peptides promoted online have never been approved, making them technically illegal to market as drugs. Several peptides, such as BPC-157 and TB-500, are banned by international sports authorities as doping substances.

But that has not stopped them from gaining a foothold in the burgeoning marketplace for wellness hacks and alternative remedies.

“I think this is a disaster in the works,” said Dr. Eric Topol of Scripps Research Translational Institute, who has studied the issue. “These peptides have no data to support their safety and efficacy.”

Meanwhile, some dietary supplement makers have begun mixing peptides into capsules, protein powders and gummies. At a recent FDA meeting, the industry argued for expanding the federal definition of supplements to permit the use of newer ingredients such as peptides in their products.

Safety risks were cited previously

When the FDA added a number of injectable peptides to its list of restricted substances in 2023, it cited safety risks including cancer and liver, kidney and heart problems.

That triggered pushback from wellness entrepreneurs, compounding pharmacies and their allies in Washington.

Last year several members of Congress, including Republican Sen. Tommy Tuberville of Alabama, sent letters to Kennedy asking him to lift limits on peptide production.

Some in the compounding industry argue that FDA restrictions have given rise to an illicit market of imported chemicals from China and other countries, which are not subject to U.S. drug standards.

Kennedy has echoed those concerns.

“With the gray market you have no idea if you’re getting a good product,” Kennedy told Rogan. “And a lot of this stuff that we’ve looked at is just very, very substandard.”

Perrone writes for the Associated Press.