Nationwide access to mifepristone, one of the two pills involved in a medication abortion, hangs in the balance after a federal judge in Texas ruled last week that the Food and Drug Administration’s approval of the drug would be put on pause following a seven-day window for the government to appeal.
The appeals process is already underway, though abortion clinics are readying contingency plans in case mifepristone’s FDA approval is put on hold.
Here is what is known and still unknown about the future of mifepristone access.
Why does this case determine mifepristone access nationwide instead of state by state?
When the Supreme Court overturned Roe v. Wade, it gave states the authority to decide whether to ban or protect abortion access.
But this lawsuit, filed by a coalition of anti-abortion groups called the Alliance for Hippocratic Medicine, seeks to overturn the FDA’s approval of mifepristone, which applies nationwide. The suit alleges that the agency did not adequately evaluate mifepristone’s safety before it greenlit the drug in 2000, and also argues the FDA should not have made the medication accessible via telehealth.
U.S. District Court Judge Matthew Kacsmaryk’s ruling was a response to a request from the plaintiffs to pause access to mifepristone while the case proceeds.
How long will mifepristone remain available where abortion is legal?
Mifepristone is still accessible in the 36 states that legally allow some form of medication abortion. That picture could change as early as Friday, the deadline Kacsmaryk set for his decision to take effect.
If Kacsmaryk’s pause, or stay, on mifepristone is allowed to stand, access to the drug would not be immediately cut off nationwide, but anyone involved in manufacturing or distributing it could face legal risk. (The FDA, though, has broad authority over enforcement decisions.) Some legal experts worry that the decision could implicate abortion providers as well, but the case does not directly target those prescribing or taking the medicine.
However, a lot more legal fighting is in store. The Justice Department appealed the judge’s decision on Monday and asked the 5th Circuit Court of Appeals to block the ruling while the appeals process plays out. If the court grants the request, mifepristone would remain FDA-approved beyond this week.
If the court denies or ignores the request, the Department of Justice could then make the same request of the Supreme Court.
“We could be in the U.S. Supreme Court by Friday,” said Lorie Chaiten, senior staff attorney with the ACLU Reproductive Freedom Project.
If higher courts ultimately block mifepristone access, what options remain for people seeking to terminate pregnancies?
The approved regimen for a medication abortion involves two drugs: mifepristone, which blocks the hormone progesterone, and misoprostol, which induces contractions.
If mifepristone is no longer available, most abortion clinics plan to use misoprostol alone to terminate pregnancies. Studies have shown that misoprostol’s success rates generally range from 80% to 95%, whereas the two-drug combo can be up to 99.6% effective.
Both drugs are safe: One analysis found that misoprostol had a 0.7% risk of major complications, whereas the two-pill regimen has a slightly lower risk. But taking just misoprostol may cause more intense side effects, such as nausea, diarrhea, chills, vomiting or cramping.
Surgical abortions are still an option in states where abortion is legal. They are more invasive than pills and involve anesthesia or sedation, but are slightly more effective and take less time. A medication abortion takes several days, but the pills can be taken at home in states where that’s permitted.
Surgical abortions can also be more expensive. Though costs vary based on insurance, the average cost of a medication abortion at Planned Parenthood is around $580, compared with $600 to $2,000 for a surgical abortion depending on the stage of pregnancy.
What options would the FDA have if its approval of mifepristone gets overturned?
If the FDA’s approval of mifepristone is revoked, the agency could choose not to take enforcement action against companies who sell or distribute the drug. But legal experts said it’s possible the FDA would have to order Danco Laboratories, the maker of mifepristone, to stop manufacturing the drug, meaning supply could become limited. Massachusetts and Washington are stockpiling mifepristone in case supply becomes an issue.
Danco could also apply again for FDA approval, but it’s unclear what data would be required to support a new application, given the unprecedented nature of the lawsuit and Kacsmaryk’s decision. Health policy experts aren’t sure if Danco would need to apply for approval under a new indication, submit new trial data, or if the company could rely on data from the 20 years the drug has been on the market.
Kirsten Moore, director of the Expanding Medication Abortion Access Project, said it could take several years for the FDA to approve mifepristone again, with at least 10 months for the review process alone.
What’s the deal with the conflicting order from a federal judge in Washington?
Less than an hour after Kacsmaryk’s ruling, a federal judge in Washington state ordered the FDA to maintain the status-quo availability of mifepristone in 17 states and Washington, D.C. while a different lawsuit over abortion pills plays out. In that case, a group of attorneys general alleged that the FDA’s current restrictions on distributing mifepristone unnecessarily hinder access.
Legal experts said the fact that the Texas and Washington decisions conflict could help expedite the case to the Supreme Court.
“It sort of puts the fire under all courts in the country to resolve the conflict as soon as possible,” said Khiara M. Bridges, a law professor at the University of California, Berkeley.
What are the broader implications of this decision beyond abortion pills?
Kacsmaryk’s decision could undermine the entire drug approval process in the U.S. and open the floodgates for legal challenges to vaccines or other essential medications disputed by certain groups, legal experts said. The decision, they said, could also disincentivize pharmaceutical companies from investing in research and development for new treatments or therapies.
“This is opening the door to basically anybody challenging any drug that they disapprove of on the theory that somebody might get hurt,” said Wendy Parmet, director of the Center for Health Policy and Law at Northeastern University.
April 11, 202301:56
Dozens of pharmaceutical stakeholders, including companies and executives, filed an amicus brief on Tuesday asserting that the Kacsmaryk’s decision would delay patient access to life-saving medications and make it more difficult to bring new drugs to market. A day earlier, more than 200 pharmaceutical executives signed an open letter criticizing the judge for undermining the FDA’s authority to approve and regulate safe, effective medicines.
Why were the plaintiffs able to challenge the FDA in the first place?
Kacsmaryk determined that the Alliance for Hippocratic Medicine could challenge the long-standing approval of mifepristone because the FDA changed its rules about the drug in 2016 and 2021. The agency first extended the window in which mifepristone could be used to terminate pregnancies from seven weeks’ gestation to 10 weeks. Then during the Covid-19 pandemic, it removed a requirement that mifepristone be dispensed only in clinics, medical offices and hospitals, thereby allowing it to be administered via telehealth.
Anti-abortion doctors involved in the suit say that treating patients for the side effects of abortion pills has opened them up to allegations of malpractice and potential liability, placed stress on them in emergency situations and taken up medical resources that could be used for other purposes.
But lawyers for the FDA and Danco have argued that the plaintiffs did not sufficiently demonstrate that FDA’s approval of mifepristone harmed them.
“No one denies that there are adverse consequences, adverse effects to any medication, including any over-the-counter painkiller or cold medication. That those people might end up in these plaintiffs’ offices and somehow it will affect these doctors’ ability to practice and their relationship with their patients — that’s just absurd,” Parmet said.
What happens from here with the larger lawsuit?
The current fight is over an early step in the legal process: the request for a preliminary injunction. Once this particular appeals process ends, Kacsmaryk could decide to hold a trial with witness testimony or to issue a summary judgment right away. If the Justice Department loses the case, it could appeal to the 5th Circuit Court, then the Supreme Court.
Parmet said the battle over Kacsmaryk’s injunction order is essentially a preview of the larger legal battle ahead, though new debates could arise as the lawsuit is adjudicated.
Source: | This article originally belongs to Nbcnews.com
