Abortion Ruling Could Undermine the F.D.A.’s Drug-Approval Authority

A federal judge’s ruling to rescind the long-standing abortion drug mifepristone’s approval by the U.S. Food and Drug Administration could pose threats to U.S. government regulators well beyond a single drug, legal experts say. says the house.

The decision by a Texas judge appears to be the first time a court has ordered a drug to be removed from the market after it was approved over an FDA objection.

If the initial judgment, a preliminary injunction issued Friday, stands up on appeal, it could open the door to litigation to challenge approval or regulatory decisions related to other drugs. If Texas’ decision is upheld, it would undermine the very fabric of the drug industry’s reliance on the FDA’s pathway for new drug development, legal experts said.

“This is a frontal assault on the FDA’s legitimacy and its discretion to make science-based decisions and the Gold Standard approval process,” said Lawrence O. Gostin. “Ultimately, it’s a very dangerous path for FDA as an agency and for the broader science-based public health decision-making.”

In the Food, Drug, and Cosmetic Act of 1938, Congress gave the FDA blanket authority to determine whether drugs are safe and effective. Inform the agency that the drug is a safe and effective treatment for an illness or medical condition.

For nearly a century, courts have typically relied on the scientific expertise and oversight of federal agencies. However, the use and approval of various medicines has been the focus of political fissures and state-level controversies over issues as diverse as the opioid crisis, Covid vaccines, and gender-related treatments.

Now, with the ruling in a Texas case and the same day’s conflicting ruling by another federal judge in another case in Washington, the question of FDA’s authority is in the spotlight like never before. Problems are almost certain to land. before the Supreme Court.

In a statement Friday night about Texas’ decision, President Biden said, “If this ruling is in effect, there is virtually no FDA-approved prescription that is safe from this kind of political and ideological attack.” said.

The powerful pharmaceutical industry has not been formally involved in the Texas ruling, nor has it indicated whether it will file a briefing in support of the FDA. I agree with others who have called the FDA the gold standard for drug approval.

“PhRMA and our members are not parties to this litigation, but are focused on ensuring a policy environment that supports the agency’s ability to regulate and provide access to FDA-approved medicines,” said VanderVeer. said Mr.

Mifepristone is the first tablet of dual abortion therapy. The plaintiff in the Texas lawsuit also targets misoprostol, his second drug that is approved for other medical conditions but used for abortion off-label. A spokeswoman for Pfizer, which manufactures a small portion of the misoprostol sold in the U.S., said it does not support off-label use of its drug, in a court statement that the company supports the FDA. declined to comment on whether to submit the

However, she said:

In a Texas lawsuit filed by a consortium of anti-abortion groups, Judge Matthew J. Kaksmalik of the United States District Court for the Northern District of Texas declared the 2000 FDA approval of mifepristone invalid. Judge Kacsmaryk, who has long-standing affiliations with conservative Christian groups and has written articles critical of the Roe v. Wade case, issued the injunction so that the FDA could appeal to a higher court. I put it on hold. Therefore, for now, mifepristone remains available.

In the Washington lawsuit, Democratic attorneys general from 17 states and the District of Columbia challenged the additional restrictions the FDA has placed on mifepristone. His judge, Thomas O. Rice, of the United States District Court for the Eastern District of Washington, issued a preliminary injunction against the FDA’s drug availability in those jurisdictions that make up the majority of states where abortion is still legal. I ordered no restrictions.

The Justice Department, which represents the FDA, immediately said it would appeal the Texas injunction to the Fifth Circuit Court of Appeals.

Following the Texas ruling, the FDA said its approval was based on the best available science and was made in accordance with the laws governing our work.

“FDA supports the determination that mifepristone is safe and effective under the approved conditions of use for medical abortion of early pregnancy, and patients should have access to an FDA-approved drug.” I think it is.”

R. Alta Charo, emeritus professor of law and bioethics at the University of Wisconsin and author of a compendium by drug policy scholars who support the FDA, said: cause confusion. The ruling could allow various groups to start “looking over the FDA’s shoulder and re-evaluating their risk-benefit analyses,” she added.

Agencies have faced a series of reputational broadsides in recent years. Under President Donald J. Trump, the FDA has been vilified for bowing to political pressure to approve Covid treatments that have proven ineffective. The company faced heavy criticism for its approval of Aduhelm, a controversial Alzheimer’s drug with uncertain benefits and significant safety risks. And it continues to face public outrage, lawmaker asking question Several opioid drugs have been given approval amid rising overdose deaths.

Some reproductive health law and drug policy experts believe that while the Supreme Court ruling that overturned Roe v. Wade allowed states to decide whether to ban or permit abortion, states could He said he did not authorize any action to ban drugs used in abortions.Because they are regulated by the FDA, states are allowed to adopt several laws and regulations that supplement federal drug regulations to regulate medical practices within their jurisdiction. Cannot impose policies that interfere with or conflict with FDA standards or requirementsAs such, federally approved drugs cannot be banned or severely restricted, these experts say.

Two federal lawsuits were filed this year against state bans or restrictions on drug abortion, alleging that FDA’s authority cannot be doubled down by states. A lawsuit filed by mifepristone manufacturer GenBioPro challenges West Virginia’s abortion ban, and another filed by a pregnant woman challenges additional restrictions that North Carolina applies to medical abortion. Proposed by a physiologist, it argues that the actions of these two states are unconstitutional.

The lawsuit argues that state abortion bans and restrictions are a commerce clause in the Constitution that prohibits states from undermining interstate commerce and a federal law — in this case allowing the FDA to regulate drugs like mifepristone. Legislative Decision to Commit — Overrides competing state laws.

“Under the U.S. Constitution, when federal and state law collide, federal law precedes state law,” say Patricia Zetler, a law professor at Ohio State University, and Ameto, an attorney and assistant professor at Harvard Medical School. Sarpatwari writes: Article in The New England Journal of Medicine last year.

This theory is rarely tested in court. One of the few relevant cases is Massachusetts About a decade ago, the decision to ban the new opioid zohydro ER was made because state officials feared the drug could be abused, leading to addiction and overdose. A federal judge upheld the drug company’s Zogenix. If states “can reverse FDA’s decisions and replace them with their own requirements, it would undermine FDA’s ability to make medicines available to promote and protect public health,” the judge said. Wrote. Then there was also an effort by the state of Massachusetts to restrict zohydro. dismissed by court.

Decisions like the one in Texas “represent judicial interference with the FDA’s true core function, handcuffing the FDA in making future safety and efficacy decisions,” Dr. Sarpatwari said. .

I. Glenn Cohen, a Harvard Law School professor and bioethics expert, said overturning the FDA’s powers would be a long-term effort to fund the risky and costly drug discovery process. He said it could be disruptive for the U.S. pharmaceutical industry, which uses drug sales outlets.

Professor Cohen, who is also author of a brief in support of the FDA, said, “If your approval could be instantly revoked by one judge, that would be really scary.”

The FDA frequently reviews new data on drugs after they are approved. This is especially true for mifepristone. Mifepristone is one of only 60 drugs that have been regulated and repeatedly re-evaluated under the framework of additional restrictions.

In rare cases, the FDA has pressured pharmaceutical companies to withdraw drugs from the market when new evidence of increased patient safety and health risks is found. For example, in 2020, Eisai asked Eisai to revoke the weight-loss drug Belbic after data showed an increased risk of cancer.

In 2004, Merck volunteered to exit the market when it discovered that the blockbuster pain reliever Vioxx doubled the risk of heart attacks and strokes in patients.

Professor Charo said the FDA’s decision to revoke drug approval could have ramifications for other federal agencies with technical expertise, such as agencies that oversee regulations related to the environment, energy and digital communications. said there is

“Imagine what can be done when there are commercial interests reeling from a multitude of issues,” Professor Charo said, adding, “There really is no end to this.”