Comment on this storyComment
The companies behind a key abortion drug are struggling to chart a path forward amid conflicting court rulings that simultaneously revoke and preserve its approval by the Food and Drug Administration, with one leading manufacturer preparing for a rush of demand.
A federal judge in Texas reversed the approval of mifepristone, one of two drugs typically used in medication abortion. Less than an hour later, a judge in Washington state ordered the FDA to preserve access in 17 states and the District of Columbia that brought a lawsuit to prevent removal of the drug from the market.
The dueling court decisions deepen the legal uncertainty for companies trying to navigate the fast-changing landscape for abortion access in the roughly nine months since the Supreme Court overturned Roe v. Wade.
In a divided nation, dueling decisions on abortion pill
Abby Long, a spokeswoman for Danco Laboratories, a New York-based pharmaceutical company that makes and markets mifepristone, said the business is preparing for abortion providers to try to stock up before the Texas decision is scheduled to take effect Friday. The company is among parties filing appeals that many observers expect to reach the Supreme Court.
She called on the FDA to clarify its approach to the conflicting rulings.
“We really do need the federal government to kind of step in,” Long said Monday. “Our distributors will need that assurance to make sure they aren’t violating the law somehow by shipping this product.”
The other U.S. manufacturer of mifepristone, Las Vegas-based GenBioPro, said there have been no supply chain disruptions in the immediate wake of the Texas ruling.
“GenBioPro is dedicated to providing evidence-based medications and will continue to use the tools that it has to lawfully do so,” said Skye Perryman, litigation counsel for GenBioPro. “This case is highly concerning when you look at what the right-wing groups are seeking to do from the perspective of attempting to undermine the [FDA’s] authority.”
Two friends were denied care after Florida banned abortion. One almost died.
More than 250 pharmaceutical executives criticized the Texas decision in a public letter, saying it “ignores decades of scientific evidence and legal precedent” coming from a federal judge with no scientific training.
“We call for the reversal of this decision to disregard science, and the appropriate restitution of the mandate for the safety and efficacy of medicines for all with the FDA, the agency entrusted to do so in the first place,” the industry leaders wrote.
FDA officials stood by the agency’s 20-year-old approval of mifepristone and has appealed the Texas ruling.
Health and Human Services Secretary Xavier Becerra demurred when asked whether his agency would refuse to enforce the Texas decisions, something that politicians on the political left including Rep. Alexandria Ocasio-Cortez (D-N.Y.) have called for.
“Every option is on the table,” Becerra said Saturday on CNN’s “State of the Union.”
HHS spokeswoman Kamara Jones later said the agency intends to keep defending the drug’s approval through the legal process.
“People are rightly frustrated about this decision — but as dangerous a precedent it sets for a court to disregard FDA’s expert judgment regarding a drug’s safety and efficacy, it would also set a dangerous precedent for the Administration to disregard a binding decision,” Jones tweeted Sunday afternoon.
Hey Jane, a provider of online abortion services, said it continues to provide telehealth visits in the eight states where it operates. Co-founder and chief executive Kiki Freedman said the Texas ruling will not diminish demand for legal and safe channels to obtain abortion pills.
“Historically, in pockets of exceptional confusion, we do see more patients coming to our site,” she said.
Abortion on Demand, which prescribes mifepristone to patients in 23 states via a network of telehealth providers, has not adjusted any of its activities after the Texas and Washington rulings, said Leah Coplon, a nurse midwife who is director of clinical operations for the online provider.
The site’s leaders and its individual providers are monitoring legal developments on a daily and weekly basis, which has been their practice since the Supreme Court overturned the 50-year-old constitutional right to abortion last year, Coplon said
“The longer this is in limbo, the more calls we get from folks anxious to make sure they can get their medication,” she said.
Abortion on Demand has not experienced any spike in demand for services after the conflicting rulings Friday, she said. If the Texas court ruling stands and mifepristone is removed from the market, providers are ready to prescribe misoprostol, a drug given in tandem with mifepristone to induce an abortion, by itself. Misoprostol alone is commonly used as a method of abortion in many overseas nations, she said.
“We basically have to be ready for anything. We have to be ready to change on a dime,” Coplon said.
Walgreens drew a line on abortion pill access and is paying a price
Walgreens, Rite Aid and CVS had previously said they intended to participate in an FDA-led program to distribute the pills in person for the first time in states where abortion is legal, a decision that drew blowback from antiabortion protesters and conservative attorneys general. Abortion rights proponents were frustrated too, with California Gov. Gavin Newsom (D) seeking to punish Walgreens for declining to carry mifepristone in some states where the drug is legal.
Rite Aid declined to comment Monday, while a CVS spokesperson did not respond to emailed requests for comment. A Walgreens spokesperson declined to comment beyond emphasizing that the company does not carry mifepristone.
“I wouldn’t be shocked if they’re feeling a little regretful to have waded into this, given that they’ve been pulled in opposing directions,” said Greer Donley, an expert in abortion law with the University of Pittsburgh.
“They’ve learned firsthand that abortion battles are very difficult for businesses,” Donley said. “This is going to give them some time and some cover to figure out what to do next.”
Source link: https://www.washingtonpost.com/business/2023/04/10/abortion-pill-ruling-texas-washington/