Current:Home > InvestGeneric abortion pill manufacturer sues FDA in effort to preserve access -DollarDynamic
Generic abortion pill manufacturer sues FDA in effort to preserve access
View
Date:2025-04-17 11:23:23
The manufacturer of a generic form of the abortion pill mifepristone is suing the Food and Drug Administration in an effort to preserve access as federal litigation threatens to overturn the FDA's approval of the drug.
In a federal lawsuit filed today in Maryland, drug manufacturer GenBioPro asks a judge to prohibit the FDA from taking any action that would disrupt access to the pills. GenBioPro says revoking the FDA approval of generic mifepristone would cause "catastrophic harm" to the company, and to doctors and patients who rely on the drug.
Mifepristone was first approved in 2000 as the first dose in a widely-used, two-drug protocol approved to induce some first trimester abortions. GenBioPro received FDA approval for its generic version in 2019.
Anti-abortion rights groups are challenging both the FDA's original 2000 decision and later rule changes, including the generic drug approval in 2019.
A temporary stay from the U.S. Supreme Court preserving status-quo access to mifepristone expires at 11:59 p.m. ET today unless the court intervenes. If the stay expires, an order from the 5th U.S. Circuit Court of Appeals would take effect and impose multiple restrictions, including prohibiting the pills from being distributed by mail.
In a filing with the Supreme Court, the FDA says it also believes that under the Fifth Circuit decision, generic mifepristone "would cease to be approved altogether."
In the new lawsuit, GenBioPro objects to the FDA's interpretation of that decision and asks a federal court to force the FDA to preserve access. The company says its generic form of the drug accounts for about two-thirds of mifepristone sold in the United States.
In a statement, Skye Perryman with the legal advocacy group Democracy Forward Foundation and one of the lawyers in the case, said the outcome could have larger significance for other medications.
"There are industry wide implications if far-right external interest groups
are able to interfere with drug availability in the country without the legal and regulatory protections provided by Congress," Perryman said. "If this were to be the case, few companies would be incentivized to develop and bring essential medications to market."
Danco Laboratories, the original distributor of mifepristone in the U.S., has joined the FDA in the case and is asking the Supreme Court to block restrictions on the drug.
In a separate case filed earlier this year, GenBioPro also sued the state of West Virginia over its state abortion restrictions, arguing that federal regulations allowing the use of mifepristone should prevail over West Virginia's state laws.
veryGood! (11488)
Related
- Spooky or not? Some Choa Chu Kang residents say community garden resembles cemetery
- Cute Valentine's Day Kitchen Essentials That Will Make Baking a Piece of Cake
- EPA: Cancer-causing chemicals found in soil at north Louisiana apartment complex
- Patriots WR Kayshon Boutte arrested for taking part in illegal sports betting while at LSU
- Small twin
- Middle school students return to class for the 1st time since Iowa school shooting
- Ring will no longer allow police to request users' doorbell camera footage
- Why Bachelor Nation's Susie Evans and Justin Glaze Decided to Finally Move Out of the Friend Zone
- Federal hiring is about to get the Trump treatment
- A new, smaller caravan of about 1,500 migrants sets out walking north from southern Mexico
Ranking
- Federal appeals court upholds $14.25 million fine against Exxon for pollution in Texas
- Ring will no longer allow police to request users' doorbell camera footage
- Truly's new hot wing-flavored seltzer combines finger food and alcohol all in one can
- A portrait of America's young adults: More debt burdened and financially dependent on their parents
- McConnell absent from Senate on Thursday as he recovers from fall in Capitol
- A bear was killed by a hunter months after it captivated a Michigan neighborhood
- Jennifer Crumbley, on trial in son's school shooting, sobs at 'horrific' footage of rampage
- Why Bachelor Nation's Susie Evans and Justin Glaze Decided to Finally Move Out of the Friend Zone
Recommendation
'No Good Deed': Who's the killer in the Netflix comedy? And will there be a Season 2?
Super Bowl 58 may take place in Las Vegas, but you won't see its players at casinos
Untangling the Controversy Surrounding Kyte Baby
Kardashian-Jenner Chef Spills the Tea on Their Eating Habits—Including the Foods They Avoid
North Carolina trustees approve Bill Belichick’s deal ahead of introductory news conference
Tennessee GOP leaders see no issue with state’s voting-rights restoration system
A Missouri nursing home shut down suddenly. A new report offers insight into the ensuing confusion
Russell Wilson gushes over wife Ciara and newborn daughter: 'The most beautiful view'