U.S. Health and Human Services Secretary Robert F. Kennedy Jr., shown here in September, cited a white paper funded and self-published without peer review by anti-abortion groups as grounds for federal scrutiny of a key abortion medication’s safety. (Photo by Andrew Harnik/Getty Images)

The U.S. Food and Drug Administration is facing increasing pressure from abortion opponents and advocates over how it regulates a drug that has become central to abortion access since Roe v. Wade was overturned three years ago.

Abortion medication manufacturers, health care providers and state attorneys general have continued to petition and sue the agency to loosen regulations for mifepristone, a key abortion drug. At the same time, anti-abortion policy leaders have successfully lobbied the Trump administration — on the basis of a self-published white paper funded by anti-abortion groups — to review mifepristone’s safety again and consider reviving old restrictions.

On Thursday, Nov. 13, the American Civil Liberties Union sued the FDA under a federal public records law for refusing to disclose the parameters of its new review, as well as communications with outside groups. 

Abortion opponents have called on the FDA to ban telehealth abortion, which has allowed abortion rates to rise slightly nationally despite state bans. A shift in mifepristone regulation could dramatically change abortion access throughout the country, and health advocates and litigators on both sides of this dispute are closely watching how the agency justifies any changes. 

Abortion-rights advocates have also seized on a recent federal ruling from a Trump-appointed judge, which orders the FDA to justify its 2023 decision to maintain restrictions on the abortion pill and argues the agency excluded from its review, without explanation, a wealth of research and evidence that it previously accepted.

Reproductive health legal experts say the action could prevent the anti-abortion white paper from being the main thing the agency considers before modifying its policy. 

“This is where the debate, both in the courts and the FDA, is taking place, around how it is considering evidence, making sure it is reviewing valid evidence and not junk evidence, and getting really reasoned explanations based in that evidence, as opposed to politics or ideology,” said Diana Kasdan, the legal and policy director for the Center on Reproductive Health, Law, and Policy at the University of California, Los Angeles School of Law. 

Where reproductive health legal experts say the abortion pill has been over-regulated for a drug with a high safety record, anti-abortion attorneys, like senior counsel Erik Baptist of the Christian-right powerhouse Alliance Defending Freedom, have been arguing that the drug’s risks are exacerbated by its increased availability. The law firm, which was integral to the overturning of Roe v. Wade, is also representing a Louisiana woman in an abortion medication lawsuit against the FDA. 

“The FDA’s actions have created an even more unsafe environment for women,” Baptist said. 
“We expect the Trump administration to zealously appeal this dangerous decision.”

‘It’s the same data set, essentially’

Putting pressure on FDA’s review team are national anti-abortion policy groups like Americans United for Life, one of several groups that criticized the agency for approving a new generic version of mifepristone this fall. The group is part of a coalition that helped produce and, at the end of April, publicize the white paper on mifepristone’s safety, which U.S. Health and Human Services Secretary Robert F. Kennedy Jr. soon after cited as the basis for ordering a new review of the drug. 

The Ethics and Public Policy Center’s self-published paper analyzed a commercially available data set of all-payer health insurance claims from 2017 through 2023 and found an 11% rate of severe adverse events — 22 times higher than the less than 0.5% rate that’s on the label for mifepristone. Reproductive health researchers have criticized the paper’s broad classification of serious adverse events while noting it also reports low rates of the most serious side effects associated with medication abortion, like sepsis (0.1%), transfusion (0.15%), and hospitalization related to the abortion (0.66%). Meanwhile more than 100 peer-reviewed studies have found low rates of serious adverse effects, including for abortion medication provided through telehealth.

The paper, which has also been cited by lawmakers like U.S. Sen. Josh Hawley of Missouri, did not go through a scientific peer review, and the Ethics and Public Policy Center would not disclose the exact data set used. Spokesperson Hunter Estes previously told States Newsroom the group was not legally permitted to provide the data set but that the paper’s description of it should be enough to replicate the study.  

Americans United for Life CEO John Mize said he hopes to see the paper peer-reviewed in the near future. But he said the coalition has for now achieved its goal of convincing the FDA to look at the same insurance claims data set analyzed by the Ethics and Public Policy Center and then do its own analysis.

“What we’ve been told is the FDA is doing their own internal analysis of the EPPC data,” Mize said. “It’s to be seen what the FDA does with methodology. That’s the important component, because the data is the data. It’s the same data set, essentially.”

HHS did not respond to questions about its ongoing mifepristone review or the federal judge’s recent order to review all of the safety data, instead directing States Newsroom to an Oct. 2 post on X from Kennedy defending both the FDA’s review of mifepristone and its approval of a second generic version. 

“Recent studies already point to serious risks when mifepristone is used without proper medical oversight,” Kennedy posted. “@US_FDA only approved a second generic mifepristone tablet because federal law requires approval when an application proves the generic is identical to the brand-name drug.”

But if the FDA’s review ultimately draws different scientific conclusions than the anti-abortion movement, Mize said his side won’t stop pursuing challenges to the drug. 

“If it comes out that it’s not nearly as dangerous as what EPPC is reporting, and the data appears to be quality and not skewed by politics, then personally, I might take a different perspective,” Mize said. “But I am still fairly confident that a drug that induces abortion at home without clinical oversight is probably something that needs a little bit more scrutiny. … We might continue to fine tune methodology and look at pursuing other avenues of peer review.”

Politicized science 

Anti-abortion policy and legal advocates have been lobbying for tighter restrictions on mifepristone since the drug was first approved in 2000, and especially since the FDA started dropping restrictions, such as allowing the regimen to be used until 10 weeks’ gestation instead of seven in 2016. After Roe v. Wade was overturned, the FDA under President Joe Biden’s administration permanently dropped the in-person dispensing requirement, allowing people to obtain the abortion pill via telehealth and through the mail. 

But the FDA maintained other regulations, as part of the drug’s Risk Evaluation and Mitigation Strategy, such as requiring prescribers, pharmacists and patients to sign forms agreeing to meet certain qualifications and acknowledging the drug’s common side effects, like heavy bleeding and nausea, and potential severe risks, like infection. Abortion providers have argued that some of the rules are unnecessary and burdensome.

Of the more than 20,000 prescription drug products approved by the FDA, less than 100 have REMS, and many of those are injectables with serious side effects like coma and death. In a quarter century, the FDA has reported 36 deaths associated with, but not necessarily caused by, mifepristone.

U.S. District Judge Jill Otake on Oct. 30 ordered the FDA to review all the relevant safety data on mifepristone, ruling that the agency erred years ago when it failed to justify maintaining strict rules on the drug despite a strong safety record after 25 years on the market. One week later, the U.S. Senate Democratic Caucus sent a letter to Kennedy and FDA Commissioner Martin Makary demanding the ongoing mifepristone review be based on science and evidence. 

“That court order reinforces that, in conducting this new review, FDA may not cherry-pick junk science serving an anti-abortion agenda, but must instead look at the full body of evidence both confirming mifepristone’s safety and underscoring the harms of the FDA’s onerous restrictions,” reads the letter obtained by NOTUS. The senators ask HHS to respond by Nov. 28, to questions about the evidence being considered and the methodology.

Anti-abortion research groups also produced new studies for their first legal attempt to reinstate restrictions on mifepristone in a lawsuit filed in 2022. The plaintiffs persuaded a Trump-appointed district court judge to order the FDA to change its policy on the basis of studies funded by the anti-abortion movement that were later retracted by the journal’s publisher because of their methodology. The U.S. Supreme Court rejected the case, not on the merits but because plaintiffs did not have proper standing. The high court is expected to consider similar questions again, as at least seven mifepristone-focused lawsuits work their way through the lower courts.

University of Pittsburgh law professor Greer Donley said that to meet the FDA’s policy on approving new drug regulations, the agency will need more than one or two outlier studies as justification. 

“To survive arbitrary and capricious review, they have to provide a reasoned decision that’s based on the facts, and if the facts taken as a whole suggest that this is a safe and effective drug, even though there’s one new paper out there that suggests it’s maybe a little less safe than it was before, they’re going to have to justify why that one paper outweighs the 50 papers on the other side that were published in peer-reviewed journals,” Donley said. “I don’t know how they could explain that.”

Donley has studied mifepristone regulation closely and said she watched the science around the medication become increasingly politicized, much more than other drugs. While controversial medicine, like gender-affirming care, involve drugs with multiple purposes, mifepristone was approved for the explicit purpose of ending a pregnancy. 

The FDA’s medication abortion regimen involves another drug, misoprostol, which was approved to treat ulcers, and is used off-label for abortions and miscarriages. It has not faced the same scrutiny as mifepristone. Abortion providers have said they would likely pivot to a misoprostol-only regimen if mifepristone were to become much harder to access, which it has even for miscarriages in states that have banned abortion entirely, like Kentucky and Louisiana.

Mifepristone manufacturer Danco Laboratories last year confirmed ongoing efforts to add miscarriage management as an approved use to its drug label. Were that to happen, it could be a game changer for access, Greer said.  

“It actually would be a pretty huge deal if they added it,” she said. “Because all of these attacks against mifepristone for abortion, even if they succeed, then mifepristone would theoretically remain on the market for miscarriage care, and then it could be used off-label for abortion.”

Read the latest on legal cases over mifepristone winding their way through the courts. 

Tomorrow, a look at efforts to both reinforce and crack shield laws across the country.

Jeff Garland, right, gives a tour of Papa G’s Organic Hemp Farm in Crawford County, Indiana, on June 23, 2022. Jeff and his son started the farm in 2020.  At left is Lee Schnell of the U.S. Natural Resources Conservation Service, which is part of the U.S. Department of Agriculture.  (NRCS photo by Brandon O’Connor)

WASHINGTON — Kentucky’s two U.S. senators sparred this week over the future of the country’s hemp industry — one arguing that a provision attached to the package that will reopen the government will close a problematic loophole and the other contending the language will regulate the industry “to death.”

Sen. Mitch McConnell ultimately prevailed and was able to keep the section in the Agriculture appropriations bill cracking down on hemp that Sen. Rand Paul tried to remove during floor debate. Both are Republicans.

The appropriations bill is riding along with a stopgap spending bill that will end the government shutdown and is expected to be voted on by the House as soon as Wednesday. The hemp measure has raised alarm in farm states benefiting from a robust hemp growing industry.

Hemp plants have 0.3% or less of tetrahydrocannabinol, or THC, while cannabis or marijuana plants have higher concentrations of that substance, which is what gives users the “high or stoned” feeling. 

A summary of the bill put together by Senate Appropriations Chairwoman Susan Collins’ staff says the new language would prevent “the unregulated sale of intoxicating hemp-based or hemp-derived products, including Delta-8, from being sold online, in gas stations, and corner stores, while preserving non-intoxicating CBD and industrial hemp products.”

The U.S. Food and Drug Administration has a warning page on its website cautioning “that delta-8 THC products have not been evaluated or approved by the FDA for safe use in any context.”

Farm Bill origins

McConnell explained he is targeting hemp because its uses have expanded beyond what was intended. 

“I led the effort to legalize industrial hemp through the 2014 pilot program and the 2018 Farm Bill,” McConnell said. “Unfortunately, companies have exploited a loophole in the 2018 legislation by taking legal amounts of THC from hemp and turning it into intoxicating substances, and then marketing it to children in candy-like packaging and selling it in easily accessible places, like gas stations and convenience stores all across our country.”

McConnell said the new provision, which won’t take effect until a year after the bill becomes law, would “keep these dangerous products out of the hands of children while preserving the hemp industry for farmers.”

Paul and Oregon Democratic Sen. Jeff Merkley urged their colleagues to remove that McConnell provision from the larger spending package, but were unsuccessful. 

“This is the most thoughtless, ignorant proposal to an industry that I’ve seen in a long, long time,” Paul said. 

The new language would change the definition of what makes a hemp plant legal, a move Paul said would mean “every plant in the country will have to be destroyed.” 

“This bill’s per-serving THC content limit would make illegal any hemp product that contains more than point four milligrams,” Paul said. “That would be nearly 100% of the existing market. That amounts to an effective ban, because the limit is so low that the products intended to manage pain or anxiety will lose their effect.”

State laws said to be nullified

The legislation, Paul added, will negatively impact the nearly two dozen states that have set higher limits on hemp production.

“Currently, Maine limits THC to three milligrams per serving. That will be overruled. My home state limits THC to five milligrams in beverages; that will be overruled. Minnesota, Utah, Louisiana also have five milligrams per serving. Alabama and Georgia have 10 milligrams. Tennessee has 15 milligrams,” Paul said. “The bill before us nullifies all these state laws.”

Merkley said the new provision in the larger spending package would eliminate the hemp industry, which Congress took steps to establish more than a decade ago.

“I support my other colleague from Kentucky who doesn’t want intoxicated products produced from hemp,” Merkley said. “But the definition that is in this bill does far more than that, and it has to be fixed. So for now, it needs to be stripped out.”

The Senate voted 76-24 to table, or set aside, Paul’s amendment after McConnell moved to block it from being taken up directly. 

The Agriculture funding bill is one of three full-year government spending bills included in the stopgap spending package that will end the government shutdown once the House approves the measure later this week and President Donald Trump signs the bill. 

Trade group warns of hundreds of thousands of jobs affected

Hemp Industry & Farmers of America Executive Director Brian Swensen wrote in a statement released last week that McConnell’s provision would have a devastating impact on the industry and its workers. 

“Congress legalized hemp, Americans built an industry, and now Washington wants to pull the rug out from under hardworking farmers and small business owners. The industry wants a solid regulatory package that protects kids, but instead, Congress wants to place industry-killing caps on cannabinoids. Congress is not listening to the industry they created — they’re dismantling an industry with over 325,000 jobs and driving consumers to an unregulated, unsafe, and untaxed black market.”

John and Kara Grady, owners of Slappyhappy Hemp Company, said during an interview with the Missouri Independent the new language could hinder their business, possibly forcing them to close down.

“You’re sick to your stomach all day long,” said Kara Grady, “knowing your hard work is for not.”

Zack Kobrin, a Fort Lauderdale attorney with the firm of Saul Ewing who works in the hemp and cannabis industry, told the Florida Phoenix that many in the industry “are surprised it was such a sudden and sweeping measure.”

“I think for those that are cowboys, they will just maximize on making as much as they can until they can’t,” Kobrin said. “I think for those hemp operators that were trying to work with regulators and trying to follow the rules, this will be a real blow.”

Blister packs of hormone replacement therapy medication. (Getty photos)

WASHINGTON — The U.S. Food and Drug Administration announced Monday it plans to remove warnings from hormone replacement therapy drugs that can be used to address symptoms of menopause, saying the statements are no longer needed. 

The black box warning, the strongest caution possible from the FDA, was added in the early 2000s after a study from the Women’s Health Initiative showed an uptick in rates of blood clots, breast cancer, heart attacks and strokes for women who used certain types of hormone replacement therapy. 

FDA Commissioner Marty Makary said during a press conference the change for estrogen-related products “is based on a robust review of the latest scientific evidence.”

Makary rebuked the medical establishment for not putting enough effort into researching women’s health conditions, including menopause. 

“A male-dominated medical profession, let’s be honest, has minimized the symptoms of menopause, and as a result, women’s health issues have not received the attention that they deserve. More than 80% of women have notable severe symptoms lasting up to eight years. How could the medical establishment get it so wrong for so long?” Makary said. “Women deserve the same rigorous sciences as is used for men.”

Study criticized

Department of Health and Human Services Advanced Research Projects Agency for Health Director Alicia Jackson said the black box warning on estrogen was based on “the flawed, overgeneralized and misinterpreted WHI study.” 

Jackson said menopause leads to a series of complicated and often painful experiences for women, including “sleepless nights, derailed careers, painful sex, broken bones and a loss of wellbeing.”

Jackson explained that when the level of estrogen drops throughout and after menopause, “a cascade of disease and aging begins.”

“A preponderance of data now shows that estrogen, when started early, acts as a protective shield for the brain, lowering risks of memory loss, mental health decline and neurodegenerative disease, even Alzheimer’s,” Jackson said.  

Makary said women should talk with their doctors and can request their estrogen levels be monitored as they approach the age where menopause typically begins and throughout that years-long process. 

He said that sometimes doctors can prescribe microdosing for hormone replacement therapy, followed by a half-dose and eventually a full dose as a woman’s estrogen levels decrease over time. 

Makary didn’t say how many of the companies that produce hormone replacement therapies plan to remove the black box warning but said he expects nearly all will do so. 

“Companies are, generally speaking, very excited when the FDA tells them they can remove a scary warning on your product,” he said. 

Review by panel

The FDA’s process for removing the black box warning requirement, Makary said, began with an expert panel earlier this year. The FDA’s subject-matter experts then conducted a “comprehensive review of the literature” and recommended the agency remove the requirement, which Makary accepted. 

The scientists who were part of the expert panel, he said, have written an article that will be published in the Journal of the American Medical Association.

President of the American College of Obstetricians & Gynecologists Steven J. Fleischman wrote in a statement that he “commends the HHS leadership for improving the lives of perimenopausal women by making the estrogen products they need more accessible to them.”

“The modifications to certain warning labels for estrogen products are years in the making, reflecting the dedicated advocacy of physicians and patients across the country,” Fleischman wrote. “The updated labels will better allow patients and clinicians to engage in a shared decision-making process, without an unnecessary barrier, when it comes to treatment of menopausal symptoms. ACOG has long advised clinicians to counsel patients based on an individual’s unique risk factors and treatment goals; this announcement does not change ACOG’s guidance on estrogen therapy.”