Latest news with #GenBioPro
Time of India
a day ago
- Health
- Time of India
West Virginia ban on abortion medication upheld
A divided federal appeals court on Tuesday upheld West Virginia's near-total ban on abortion, including limits on the widely used medication abortion drug mifepristone. The 4th U.S. Circuit Court of Appeals in Richmond, Virginia, said the Food and Drug Administration's approval of mifepristone did not preempt West Virginia's law as applied to medication abortions, which account for more than half of U.S. abortions. Circuit Judge J. Harvie Wilkinson said a 2007 federal law giving the FDA more authority over "high-risk" drugs did not evince a clear intention to displace states' traditional right to protect their citizens' health and safety. Wilkinson also found no indication that Congress intended to guarantee nationwide access to mifepristone. "The debate joined by able and dedicated supporters and opponents of access to abortion medications is simply not one, in the absence of clear congressional direction, for this court to decide," the judge wrote. Tuesday's 2-1 decision is the first by a federal appeals court to say states can restrict use of the pill. In June 2024, the U.S. Supreme Court preserved access to mifepristone, rejecting an effort by anti-abortion doctors and groups to roll back FDA approval. West Virginia's law had been challenged by GenBioPro, a Nevada company that sells a generic version of mifepristone. Opponents said letting the law stand could allow other states to criminalize access to federally approved medications. The law "sets a dangerous precedent regarding access to other evidence-based health care that (the) FDA has deemed safe and effective," said Skye Perryman, president of the nonprofit Democracy Forward, which helped represent GenBioPro. Erin Hawley, a lawyer representing West Virginia, said the court "rightly refused GenBioPro's invitation to federalize the issue of abortion." Hawley is senior counsel at the nonprofit Alliance Defending Freedom, which also brought the Supreme Court mifepristone case. Governor Patrick Morrisey , a Republican who defended West Virginia's law as that state's attorney general, called the decision a "big win" that lets West Virginia "lead the nation in our efforts to protect life." DISREGARDING SUPREME COURT 'NOT AN OPTION' Mifepristone is the first pill, followed by the drug misoprostol, for medication abortion in the first 10 weeks of pregnancy, and won FDA approval in 2000. Twenty-eight states restrict access to medication abortions, according to the nonprofit Guttmacher Institute, which focuses on reproductive health. West Virginia's Unborn Child Protection Act banned abortion with narrow exceptions, including within the first 14 weeks of pregnancy for minors who are victims of rape and incest. Without opining on the law, Wilkinson said federal courts shouldn't substitute their policy preferences for those of state legislators. He also said voiding the law would amount to near "defiance" of Dobbs v. Jackson Women's Health Organization , the 2022 Supreme Court decision that eliminated the federal constitutional right to abortion. "Just after the Supreme Court restored the states' traditional authority to regulate abortion, GenBioPro would have us wrest it right back," Wilkinson wrote. "At a time when the rule of law is under blunt assault, disregarding the Supreme Court is not an option," he added. Wilkinson was appointed to the bench by Republican President Ronald Reagan. His opinion was joined by U.S. District Judge Rossie Alston, an appointee of Republican President Donald Trump who normally sits in Alexandria, Virginia. Circuit Judge DeAndrea Gist Benjamin, an appointee of Democratic President Joe Biden, dissented, saying West Virginia's law "erects barriers to life-saving healthcare for countless West Virginians in ways not envisioned by Congress." She also said the law could unduly burden patients in medically underserved areas elsewhere by forcing West Virginians to travel to other states for treatment. Tuesday's decision upheld an August 2023 ruling by U.S. District Judge Robert Chambers in Huntington, West Virginia.
The Hill
2 days ago
- Health
- The Hill
Appeals court upholds West Virginia's medication abortion ban
A divided federal appeals court panel on Tuesday upheld West Virginia's ban on medication abortion, ruling that the law does not conflict with the Food and Drug Administration's ability to regulate the drug. The U.S. Court of Appeals for the Fourth Circuit dismissed mifepristone manufacturer GenBioPro's effort to strike down West Virginia's near-total abortion ban in a 2-1 decision. The court ruled FDA's approval of mifepristone did not preempt West Virginia's law. GenBioPro produces a majority of the mifepristone sold in the United States, and has held FDA approval for generic mifepristone since 2019. GenBioPro argued that FDA's authority to impose regulations on the prescription and distribution of mifepristone superseded state efforts to restrict access to medications. A lower court ruled against the company, which then appealed the decision. Circuit Judge J. Harvie Wilkinson wrote that a 2007 federal law 'leaves the states free to adopt or diverge from West Virginia's path' and it 'falls well short of expressing a clear intention to displace the states' historic and sovereign right to protect the health and safety of their citizens.' The ruling is the first time a federal appeals court has said states can restrict use of mifepristone. Twenty-eight states restrict access to medication abortions, according to the reproductive health nonprofit Guttmacher Institute. The Supreme Court upheld access to mifepristone last year, when it unanimously dismissed a lawsuit seeking to roll back changes FDA made in 2016 and 2021 to expand access. 'We respect the fact that appellant and some amici have argued that access to mifepristone is important to the health of women in the course of their reproductive choices,' Wilkinson wrote. 'Our objection is not to the substance of this point, but to the venue in which it is advanced.' Wilkinson was appointed by President Reagan. He was joined by U.S. District Judge Rossie Alston, an appointee of President Trump. 'The court is allowing the state to continue putting those seeking medication abortion care in harm's way,' GenBioPro CEO Evan Masingill said in a statement. 'The panel's ruling allows states to restrict access to medications that FDA has deemed safe and effective, threatening a dangerous ripple effect on the availability of essential medications in this country. As we have always made clear, GenBioPro will not stop fighting to ensure all people can access safe, evidence-based healthcare.' West Virginia Gov. Patrick Morrisey (R) said in a statement he was 'proud to see a victory in this case.' 'West Virginia can continue to enforce our pro-life laws and lead the nation in our efforts to protect life. We will always be a pro-life state!' he said. In a dissent, Circuit Judge DeAndrea Gist Benjamin said the state's law 'erects barriers to life-saving healthcare for countless West Virginians in ways not envisioned by Congress.' Benjamin, who was appointed by former President Biden, added that 'the twin sensitivities of abortion access and states' rights cannot influence our willingness to recognize the Food and Drug Administration's (FDA) clear authority in this area.' 'By criminalizing medical providers and prohibiting medication abortions, then, West Virginia has exceeded the ability to regulate abortion as established in Dobbs and has trespassed on the FDA's authority to regulate the safe use of and unburdened access to mifepristone,' Benjamin wrote.
Time Magazine
08-05-2025
- Health
- Time Magazine
Evan Masingill
Evan Masingill had been working at GenBioPro, a leading manufacturer of the medications used for abortion, for about a decade before he took on the role of CEO in 2022— two weeks before the U.S. Supreme Court overturned Roe v. Wade. Leading the pharmaceutical company at that time only further solidified 'that I was doing exactly what I was supposed to do,' Masingill says. GenBioPro, which manufactures only the abortion medications mifepristone and misoprostol, has a 'North Star' that guides its work, Masingill says: reproductive freedom for all people. Masingill says the company's tagline since it was launched in 2012 is 'putting access into practice.' And GenBioPro has committed to that core value. In 2019, the company obtained approval from the U.S. Food and Drug Administration (FDA) to sell the first generic mifepristone tablet in the U.S., which GenBioPro said 'has helped stabilize supply and satisfy the rising demand among patients for medical abortion.' Medication abortion is the most common method of abortion in the U.S. and has become essential for people living in states where abortion is banned or restricted. GenBioPro is now fighting to protect access to its products. In February, GenBioPro asked a Texas court to include the company as a defendant in a lawsuit filed by state attorneys general from Missouri, Idaho, and Kansas that is seeking to roll back a series of FDA policies implemented during the Biden Administration that have facilitated access to medication abortion. One change the state attorneys general are seeking, for instance, is reinstating the requirement that mifepristone be dispensed in person rather than by mail. In October, GenBioPro urged a federal appeals court to side with it in a lawsuit it filed against West Virginia in 2023 over the state's near-total abortion ban, arguing that the FDA's approval of abortion pills supersedes the state's ban. Masingill says this work is necessary and that there will always be people in power who try to restrict access to care. 'Does it grind my gears or get me heated?' he says. 'Of course. Is it sad? Yeah. But that doesn't mean we can't do anything.'
Yahoo
26-02-2025
- Health
- Yahoo
Abortion pill maker enters legal battle over FDA rules
The country's only manufacturer of generic abortion medication asked to be a part of the first legal fight over the procedure since President Trump returned to office. The company, GenBioPro, filed a motion on Tuesday in the United States District Court for the Northern District of Texas, Amarillo Division, asking to be added to the list of defendants in a case seeking to restrict access to the abortion drug mifepristone. If a judge grants the company its request, it means the company would be allowed to lead the case's defense. The case, called Missouri et al. v. FDA, is a revamped version of a lawsuit filed by anti-abortion groups and doctors in 2023 seeking to block the Food and Drug Administration's (FDA) approval of the abortion medication. After the Supreme Court decided to uphold access to mifepristone last year, the challenge was revived by conservative attorneys general in Missouri, Kansas and Idaho, directly challenging GenBioPro's approval of its generic version of mifepristone. Those states want the FDA to ban telehealth prescriptions for mifepristone, ban the drug's use after seven weeks of pregnancy and prevent pharmacies from dispensing the drug. 'We remain concerned about extremists and special interests' attempts to undermine the US Food and Drug Administration's regulatory authority,' said GenBioPro CEO Evan Masingill in a statement. 'All people have a right to access safe, affordable, evidence-based health care, and GenBioPro remains committed to using all legal and regulatory tools to protect mifepristone for millions of patients and providers across the country,' he continued. 'Despite the overwhelming majority of Americans—including constituents of these attorneys general—supporting the legal right to abortion, these politicians remain determined to severely restrict access to a critical drug that Americans depend on,' said Skye Perryman, president and CEO of Democracy Forward which is representing GenBioPro in its case along with lawyers from Arnold & Porter. 'Their baseless attacks not only jeopardize the availability of mifepristone, but also threaten the integrity of our nation's drug regulation system,' Perryman added. Medication abortions typically require the use of two drugs: mifepristone, which blocks the hormone needed for a pregnancy to continue and misoprostol, which induces contractions in the uterus to empty it. Most abortions in the U.S. are medication abortions with the method making up 63 percent of all abortions in the country in 2023, according to reproductive health research group The Guttmacher Institute. The FDA approved BioGenPro's generic form of mifepristone, mifepristone tablets 200 mg, in 2019. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
The Guardian
26-02-2025
- Health
- The Guardian
Abortion pill manufacturer asks to join suit that could rewrite US abortion access
The manufacturer of the generic version of a major abortion pill has asked to join a federal lawsuit over the pill's future, marking a new step forward in litigation that could rewrite US abortion access. The manufacturer, GenBioPro, filed court papers on Monday to become a defendant in the lawsuit over mifepristone, one of two drugs typically used in a US medication abortion. That lawsuit, which was brought by the Republican attorneys general of Idaho, Missouri and Kansas, seeks to reverse FDA regulations that dramatically expanded access to the pill, such as provisions that permit providers to prescribe it through telehealth. Medication abortions account for more than 60% of US abortions. Last year, tens of thousands of them were provided through telehealth, including to women living in states with abortion bans, according to #WeCount, a research project by the Society of Family Planning. 'Despite the overwhelming majority of Americans – including constituents of these attorneys general – supporting the legal right to abortion, these politicians remain determined to severely restrict access to a critical drug that women across America depend on,' Skye Perryman, president and CEO of Democracy Forward, said in a statement. Lawyers from Democracy Forward are serving on GenBioPro's legal team. Perryman continued: 'Their baseless attacks not only jeopardize the availability of mifepristone, but also threaten the integrity of our nation's drug regulation system.' The lawsuit is a continuation of a case that reached the US supreme court last year. It was first brought by an anti-abortion coalition known as the Alliance for Hippocratic Medicine. In a 9-0 ruling, the justices found that the coalition lacked the legal standing to bring the case and sent it back to a lower court. However, Judge Matthew Kacsmaryk of the northern district of Texas, ruled in January that the attorneys general from Idaho, Missouri and Kansas could continue the case for now. Kacsmaryk, who was appointed by Donald Trump, had in the earlier version of the case issued a court order that would yank mifepristone from the market entirely. That order was frozen by higher courts. Under Joe Biden, the FDA defended itself against the lawsuit and argued in favor of maintaining the FDA's current regulation of the drug. Under Trump, however, the FDA is widely expected to drop out of the case. Danco Laboratories, which manufactures mifepristone under the brand name Mifeprex, is already a defendant in the suit. Sign up to This Week in Trumpland A deep dive into the policies, controversies and oddities surrounding the Trump administration after newsletter promotion More than 100 studies, conducted across decades and dozens of countries, have found that mifepristone and misoprostol, the second drug normally used in US abortions, are safe. Other states, meanwhile, are taking aim at providers' ability to dispense abortion pills across state lines. Texas has filed a civil lawsuit against a New York doctor who allegedly prescribed pills to a woman in Texas, while Louisiana is pursuing a criminal case against the same doctor. New York, which has a shield law in place to protect abortion providers who operate in other states, has declined to sign Louisiana's extradition order.
