Justice Department asks Supreme Court to intervene in abortion drug ruling

By Ariane de Vogue, Tierney Sneed and Devan Cole, CNN
Updated 11:24 AM EDT, Fri April 14, 2023

The Justice Department asked the Supreme Court Friday to intervene in an emergency dispute over a Texas judge's medication abortion drug ruling, requesting that the court step in now rather than wait for an appeal to formally play out at the federal appellate level.

The case is the most important abortion-related dispute to reach the high court since the justices overturned Roe v. Wade last term. It centers on the scope of the US Food and Drug Administration's authority to regulate a drug that is used in the majority of abortions today in states that still allow the procedure.

Solicitor General Elizabeth Prelogar said in the filing that it "concerns unprecedented lower court orders countermanding FDA's scientific judgment and unleashing regulatory chaos by suspending the existing FDA-approved conditions of use for mifepristone."

She said that if the ruling were allowed to stand it would "inflict grave harm on women, the medical system, the agency, and the public."

Danco, a manufacturer of the drug, also asked the justices to step in on an emergency basis before Friday, with an attorney for the company saying in its filing that leaving the lower court opinion in play will "irreparably harm Danco, which will be unable to both conduct its business nationwide and comply with its legal obligations under the FDCA nationwide."

"The lack of emergency relief from this Court will also harm women, the healthcare system, the pharmaceutical industry, States' sovereignty interests, and the separation-of-powers," the attonrey, Jessica L. Ellsworth, told the justices.

The clock is ticking. If the Supreme Court does not step in, the district court's ruling, as amended by a subsequent appeals court opinion, will go into effect at midnight CT, and access to the drug, Mifepristone, will be restricted while the appeals process plays out.

Both the government and Danco are asking the court to freeze the lower court opinion, or alternatively, agree to take up the case themselves and hear arguments before the summer recess, a very expedited time frame.

The controversy began when US District Court Judge Matthew Kacsmaryk issued a broad ruling that blocks the FDA's 2000 approval of the drug, as well as changes the FDA made in subsequent years to make the drug more accessible.

Late Wednesday, the 5th US Circuit Court of Appeals froze part of the ruling. The court said the drug, that was approved in 2000, could stay on the market, but agreed with Kacsmaryk that access could be limited.

The appeals court ordered a return to the stricter, pre-2016 FDA regime around the drug, which prevents mailing the pill to patients who obtained it through telehealth, or virtual visits with their providers rather than traveling to a clinic or hospital to obtain the drug in person.

The restrictions also affect the instructions on the label for the medication, shortening the window of obtaining the pill to seven weeks into pregnancy as opposed to 10. It's possible however that even with the ruling in effect, some providers could go "off-label" and continue to prescribe mifepristone up until 10 weeks. Mifepristone is one of the drugs used for an abortion via medication as opposed to surgery.

Prelogar, the solicitor general, argued in her filing to the Supreme Court that the FDA's expert judgment should not be challenged.

"FDA has maintained that scientific judgment across five presidential administrations, and it has modified the original conditions of mifepristone's approval as decades of experience have conclusively demonstrated the drug's safety," she wrote, reminding the justices that currently, "more than half of women in this country who choose to terminate their pregnancies rely on mifrepristone to do so."

She highlighted a key threshold issue in the case, arguing that the doctors opposed to abortion who are behind the suit do not have the legal right to be in court. That is because, she said, they neither "take nor prescribe" the drug, and the FDA's approval "does not require them to do or refrain from doing anything."

CNN Supreme Court analyst Steve Vladeck, who is a professor at the University of Texas School of Law, said the 5th Circuit's ruling "froze the craziest, most harmful parts of Kacsmaryk's ruling," but that access to mifepristone is still significantly limited.

"The panel ruled that the challenge to the 2000 approval of mifepristone itself is likely time-barred, so it froze that part of the ruling," he wrote on Twitter. "But it *didn't* freeze Kacsmaryk's block of the 2016 and 2021 revisions that (1) make mifepristone available up to 10 weeks; and (2) by mail."

Medication abortion has emerged a particularly heated flashpoint in the abortion legal battle since the Supreme Court last year overturned the Roe v. Wade precedent that protected abortion rights nationally.

In November, anti-abortion doctors and plaintiffs brought the lawsuit challenging the FDA's 2000 approval of the drug and targeting how the agency has since changed the rules around its use in ways that have made the pill easier to obtain.

A split 5th Circuit panel said in its order that it was reinstating the approval of the drug because of certain procedural obstacles the plaintiffs face in challenging it. But the appeals court said that the abortion pill's defenders had not shown that they were likely to succeed in defeating the plaintiffs' claims against the FDA's more recent regulatory actions toward mifepristone.

The appellate order was handed down by Circuit Judges Catharina Haynes, a George W. Bush nominee, and Kurt Engelhardt and Andrew Oldham, both Donald Trump nominees. Haynes, however, did not sign on to some aspects of the order.

The FDA approved mifepristone after a four-year review process. It has shown to be a safe and effective way to terminate a pregnancy in the two-plus decades it's been on the market. But anti-abortion doctors and medical associations allege that the agency ran afoul of the law by not adequately taking into account the drug's supposed risks.

This story has been updated with additional developments.

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Texas abortion drug ruling could create 'slippery slope' for FDA approvals, drug research and patients, experts say

By Jen Christensen, CNN
Published 6:47 AM EDT, Fri April 14, 2023

What happened in one judge's courtroom in Texas could have drastic effects for the United States' entire drug approval process, experts warn.

US District Judge Matthew Kacsmaryk's ruling that suspended the US Food and Drug Administration's approval of the medication abortion drug mifepristone was an unprecedented one, the first time a court has bypassed the federal system set up to determine what drugs should be allowed on the market.

Massachusetts Democratic Gov. Maura Healey, front, faces reporters as U.S. Sen. Elizabeth Warren, D-Mass., behind center left, looks on, Monday, April 10, 2023, during a news conference in front of the Statehouse, in Boston. Massachusetts is stockpiling enough doses of mifepristone to last for more than a year Healey said Monday, April 10. (AP Photo/Steven Senne)
Opinion: The insidious challenge to science at the heart of the abortion pill ruling
Regardless of whether the ruling – or a part of it – is ultimately allowed to stand, legal scholars, scientists and drugmakers are concerned that the decision could start a trend of drugs being targeted in courts, creating a chilling effect on drug development in the US and hurting patients in the process.

Vaccines, including the Covid-19 shots, antidepressants and psychotropic medicines could be at risk, some said.

"Well, one does not want to be Chicken Little," former FDA Commissioner Dr. Jane Henney said Wednesday, but "I can't imagine that it wouldn't have implications for other products.

"The approval process will be at risk, and it's not just an approval process that patients rely on and providers rely on, it's one that has been considered the gold standard, really, for the world," said Henney, who was the head of the FDA when mifepristone was approved.

Since the dawn of the 20th century, the FDA has had the sole authority in the United States to regulate drugs. In 1906, the federal government created the agency to enforce the Pure Food and Drug Act, which was instituted to ensure that medicine, food and cosmetics were safe.

Over the years, that authority became more defined.

After elixir of sulfanilamide, a drug used to treat streptococcal infections, killed 107 people in 1937, Congress created the Food, Drug, and Cosmetic Act. Signed into law in 1938 by President Franklin D. Roosevelt, it required manufacturers to conduct pharmacological studies to prove that their drugs were safe before they could be sold or advertised. In 1962, drug manufacturers were also required to prove to the FDA that their products were effective.

Mifepristone pill
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Modern drug approval in the US is a careful and conscientious process. Before any drug goes to market, there are countless hours of research, the work and expertise of multiple scientists, and several layers of oversight for approval.

Until now, the courts have been deferential to the FDA's process and have never overturned an FDA decision on the grounds that the agency misjudged the science, said William Schultz, a former deputy commissioner at the FDA and former general counsel for the Department of Health and Human Services.

"Any FDA drug approval involves hundreds of judgments by the agency. And if a court feels free just to kind of take a fresh look at each of those, there's a chance that a court will find one of those FDA judgments wrong," Schultz said in an online discussion Monday about the impact of the Texas court's ruling that was hosted by Protect Our Care, an organization that advocates for equitable and affordable health care.

An 'assault on science'
Hundreds of well-known biotech and pharmaceutical company leaders, concerned about the effects of Kacsmaryk's ruling on other drug approvals, signed an open letter Monday in support of the FDA's authority "to approve and regulate safe, effective medicines for every American."

The letter also advocated a reversal of the mifepristone decision from a judge with "no scientific training," saying it "set a precedent for diminishing FDA's authority over drug approvals, and in so doing, creates uncertainty for the entire biopharma industry."

FILE PHOTO: Boxes of mifepristone, the first pill given in a medical abortion, are prepared for patients at Women's Reproductive Clinic of New Mexico in Santa Teresa, U.S., January 13, 2023. REUTERS/Evelyn Hockstein/File Photo
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In a separate statement, the biotech industry group BIO's interim president and CEO, Rachel King, emphasized the "dangerous precedent" the decision sets.

"The preliminary ruling by a federal judge in Texas is an assault on science and the FDA's long-standing role as the authority to make decisions on the safety and efficacy of medicines. For a court to invalidate the approval of a drug that was reviewed and approved more than two decades ago is without precedent. As legal scholars have noted, the courts do not have the medical expertise to make these types of scientific determinations," King said.

The main lobbying group for the pharmaceutical industry, PhRMA, criticized Kacsmaryk's ruling as undermining the regulatory process.

"PhRMA has serious concerns with any court substituting its opinion for the FDA's expert approval decision-making," said James C. Stansel, the association's executive vice president, general counsel and corporate secretary. Stansel added that such a decision could have a "chilling effect on the research and development ecosystem."

Mifepristone (Mifeprex) and Misoprostol, the two drugs used in a medication abortion, are seen at the Women's Reproductive Clinic, which provides legal medication abortion services, in Santa Teresa, New Mexico, on June 17, 2022. Mifepristone is taken first to stop the pregnancy, followed by Misoprostol to induce bleeding. - In the wake of Friday's ruling by the US Supreme Court striking down Roe v Wade and the federally protected right to an abortion, women from Texas and other states are traveling to clinics like the Women's Reproductive Health Clinic in New Mexico for legal abortion services under the state's more liberal laws. - RESTRICTED TO EDITORIAL USE (Photo by Robyn Beck / AFP) / RESTRICTED TO EDITORIAL USE (Photo by ROBYN BECK/AFP via Getty Images)
Concerned about the courts, some states and universities are stockpiling abortion drugs
The pharmacutical sector is a huge part of the American economy. Of the world's 25 largest phamacutical companies, 10 are based in the US, and most of the others have a large base of operations in the country.

Often, the US market is the first to get access to new drugs, but that could change if lawsuits undermine the regulatory integrity of the FDA process, said Susan Lee, partner in the law firm Goodwin's Life Sciences group and Life Sciences Regulatory & Compliance practice, who works with companies to get drugs approved by the FDA.

"If there do tend to be more lawsuits like this, I wonder if there might be a little bit of a tendency to not always look at the US as the first market," Lee said. "Some manufacturers may say 'we'd rather go to Europe, where we're not going to be sued on a jurisdiction-by-jurisdiction basis.' "

Lee also wonders whether manufacturers will abandon efforts to develop drugs that could be considered unappealing to some, such as those that help women's health or work to prevent HIV.

"I think there are just certain sectors that are already kind of thinking about whether they might also have a target on their back. I've definitely heard that discussed," Lee said.

What could be next?
The groups at the heart of the Texas case have not disclosed any further plans regarding lawsuits over medications, but experts say they are already hearing concern.

State Reps. Jennifer Canady, left, and Jenna Persons-Mulicka embrace after the Republican-dominated Legislature on approved a ban on abortions after six weeks of pregnancy, Thursday, April 13, 2023, in Tallahassee, Fla. (Alicia Devine/Tallahassee Democrat via AP)
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"I've already been getting questions from lawmakers and other people about 'could the Covid vaccine be next?' or other things that may have stigma around it," said Dr. Kristyn Brandi, an ob/gyn and abortion provider in New Jersey and a spokesperson for the American College of Obstetricians and Gynecologists.

The Covid-19 vaccines have been thoroughly tested and found to be safe and effective, but they're the subject of conspiracy theories and misunderstanding about how mRNA vaccines were tested. Beliefs that the vaccines were tested on recently harvested aborted fetal cells made some people decidedly anti-vaccine.

Dr. Lynn R. Goldman, professor and dean of the Milken Institute School of Public Health at George Washington University, is also concerned that mRNA vaccines could be targeted soon.

US Vice President Kamala Harris delivers remarks for the 50th commemoration of the Supreme Court's Roe v. Wade decision in Tallahassee, Florida, on January 22, 2023.
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"There might be people who disagree with some of the technologies that are used by vaccine makers, like the mRNA vaccines, but feeling uncomfortable about a technology is not the same thing as identifying that there is risk," she said in the Protect Our Care conversation.

Members of the LGBTQ+ community may also be vulnerable, experts say, as activists could target puberty blockers or hormones used in gender-affirming therapy.

"I don't like to do slippery slope, but I'm also very worried about things like gender-affirming care, since there's already been so many laws about that recently in other states," Brandi said.

There is political pressure against other vaccines, antidepressants and psychotropic medicines, among others, former FDA Commissioner Margaret Hamburg and former Principal Deputy Commissioner Joshua Sharfstein wrote in an editorial published Thursday in the journal Science.

"If judges begin to dictate the terms of medication access, then others will seek to use ideology and influence to advance their agendas," they warn.

A 'serious moment' for doctors and patients
Goldman said that any legal decision that could undermine the FDA drug approval process would ultimately hurt the doctors who prescribe them and the people who use them.

Doctors don't have time to vet all the studies used to prove that a drug is safe and effective, so they rely on the FDA for this work, she said. Court interference could confuse this process.

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"I think that this is, for doctors, an incredibly serious moment, because up to now, we have been able to trust that an approval by the FDA is a science-based decision and that we can say that if the FDA has approved a drug, that it is safe for us to use," Goldman said.

A lack of confidence in the drug approval process will ultimately hurt people far beyond the most recent decision, Protect Our Care Chair Leslie Dach says.

"Confidence that the FDA can do its work is essential for clinicians and patients who depend on it in its decision-making for matters of life and death," Dach said.

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Telehealth medication abortions surged since Dobbs decision. They could become harder to access if the latest court decision stands

By Annette Choi, CNN
Published 11:08 AM EDT, Fri April 14, 2023
Close up of a woman using her phone at home.
Close up of a woman using her phone at home.
Geber86/E+/Getty Images
CNN
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Medication abortions provided by virtual-only providers accounted for an increasing share of total abortions in the United States, since the Supreme Court eliminated the constitutional right to abortion in June 2022, according to a new report by the Society of Family Planning, a nonprofit focused on abortion and contraception.

While total abortions decreased by 2% from April to December 2022, medicated abortions via telehealth increased by 136%. In April, there were less than 4,000 medicated abortions provided virtually, and in December, there were more than 8,500.

Medication abortions already accounted for more than half of all US abortions in 2020, according to the Guttmacher Institute. The new data from the Society of Family Planning suggests that rate likely increased in the aftermath of the Dobbs decision.

A federal appeals court voted to freeze parts of a Texas judge's ruling that would have suspended the US Food and Drug Administration's approval of mifepristone, the first drug in the two-step medication abortion regimen late Wednesday. The freeze means that the abortion pill will still be available in the United States, but could be harder to get. The appeals court said that the judge's suspension of several revisions to the drug's rules since 2000 — including one that makes the pills available by telehealth and in the mail — could go into effect.

On Thursday, the Department of Justice requested the Supreme Court intervene in the emergency dispute over the abortion drug.

The Society of Family Planning collects data from abortion providers nationwide including from clinics, private medical offices, hospitals and virtual providers. More than 80% of providers the nonprofit identified participated in the analysis. Data from popular overseas telehealth provider Aid Access medication abortion is not included in the report, since it is not part of the formal US healthcare system. However, a study from last November found that there were about 6,500 requests made per month to Aid Access for medication abortion.

Before the Dobbs decision, 5% of all abortions were provided via telehealth, and after the ruling, that rate grew to 9%. While the share of telehealth abortions dropped off in a few states, including Georgia and Wyoming, it surged in 27 states across the country last year.

Wyoming by far recorded the highest rate of telehealth abortions both before and after the Dobbs ruling of any state. Before the ruling, 92% of abortions in Wyoming were provided via telehealth, and in the months following the decision, that rate dropped to about 80%.

Despite the heavy dependence on virtually provided medication abortions, Wyoming became the first state to explicitly ban the use of abortion pills with a law that takes effect on July 1.

In Idaho, 17% of all abortions that took place before the ruling were provided through virtual-only services. In the months that followed, that rate jumped to 43%. That's an increase of 26 percentage points — the largest of any state.

Several of the 17 Democratic-led states involved in the Washington lawsuit that sued to expand access to abortion pills, such as Colorado and Maine, also recorded some of the most substantial increases in telehealth abortions as a percent of all abortions. In those states, and the District of Columbia, 8% of abortions before the Dobbs ruling were provided virtually. And afterward, the rate increased to nearly 13%.