WASHINGTON — Vaccines, birth control pills, hormone therapies and fertility drugs could face new litigation if the Supreme Court upholds a challenge to the abortion pill mifepristone, pharmaceutical industry experts warn.
When is the trial? Tuesday Weighs whether to reverse Food and Drug Administration findings to make mifepristone more readily available; most abortions nationwide, on this line.
The pharmaceutical industry sounded the alarm, telling both the judges in the lawsuits and anyone who would listen that giving individual federal judges the power to reject the agency’s scientific health and safety findings would cause chaos in the sector.
This will likely lead to lawsuits over other drugs, both existing and not yet approved, that people have strong feelings about.
If anti-abortion groups win, “anyone with an ideological difference can challenge the FDA’s authority with a scientifically untrained judge,” said physician and entrepreneur Amanda Banks. signed the brief along with dozens of other pharmaceutical managers and companies that support the FDA.
The major pharmaceutical industry group, PhRMA, also submitted a reference in support of the government.
Some activists have long objected to certain vaccines without proof they can cause autism. During the Covid-19 pandemic, there have been largely unfounded concerns vaccine skeptics that vaccines are not safe.
Anti-abortion activists, some of whom oppose all contraceptives, have long opposed the morning-after pill, likening it to abortion despite the evidence. suggests otherwise.
There are LGBTQ activists appealed to the FDA to specifically approve the use of hormone therapies for sex-affirming treatments. There are groups that oppose gender-affirming care for transgender youth asked the FDA to prevent puberty blockers from being prescribed to minors.
Other drugs that could be at issue include drugs that use embryonic stem cells, drugs that treat HIV/AIDS, and fertility drugs used for in vitro fertilization, industry experts and the FDA support.
There is also concern for business leaders that a ruling against the government could stifle innovation by deterring investors in an industry that relies on billions of dollars in research and development to bring drugs to market.
“My biggest concern is the precedent it sets … it could have a chilling effect on investors who come into our business and invest in our innovative companies,” said Paul Hastings, an industry veteran who is CEO of Nkarta Therapeutics and who signed the deal. Same short as Banks.
He and others pointed out that the FDA is considered the “gold standard” of drug regulation around the world. For investors, FDA approval is the final part of a rigorous and expensive process. Only 1 in 10 drugs in development make it to market, Hastings said.
If FDA approval only leads to constant litigation, investors may seek safer bets, he added.
In court documentsThe FDA itself has said that no court has ever limited access to an approved drug by “second-guessing FDA’s expert judgment about the conditions required to ensure the drug’s safe use.”
When the agency began the process of lifting restrictions on the drug in 2016, its actions were “supported by dozens of scientific studies and an exhaustive review of the record that includes decades of safe use of mifepristone by millions of women,” he said.
Abortion opponents, doctors and other medical professionals argue that the FDA did not sufficiently consider safety concerns when mifepristone restrictions were lifted.
Erin Hawley, a lawyer for the conservative Christian group defending the lawsuit for the plaintiffs, dismissed the idea that the case could have such far-reaching implications, calling it a “red herring.”
He said in an interview that the FDA has not identified any other drug approvals that would be threatened.
“The reason is that it is highly unusual for the FDA to decide to remove long-term protection for women who choose to take mifepristone,” she said.
According to a spokesman, ADF does not intend to challenge any other drug approvals.
The Supreme Court has a 6-3 conservative majority that is hostile to abortion rights, most prominently in 2022 when Roe v. v. Wade, it said in a decision that overturned it.
The legal question in Tuesday’s case focuses not on the abortion itself, but in part on whether the FDA followed the proper processes to ease restrictions on mifepristone.
The plaintiffs filed suit in federal court in Texas, where the case was guaranteed to be assigned to conservative Judge Matthew Kaczmaric, appointed by President Donald Trump.
Last April, Kacsmaryk issued a sweeping ruling that invalidated the FDA’s approval of the drug decades ago.
That was the verdict put it on hold issued by the Supreme Court and later narrowed by the US 5th Circuit Court of Appeals.
The original approval of mifepristone in 2000 is not an issue before the courts. The lawsuit focuses on actions by the FDA since 2016 that made the pill easier to obtain, including an initial decision that made it available by mail until 2021, which was finalized last year.
Judges will also examine decisions in 2016 to extend the window in which mifepristone can be used to terminate a pregnancy from seven weeks to 10 weeks, and to reduce the number of in-person visits for patients from three to one. In another move in 2016, the FDA changed the dosing regimen, finding that a lower dose of mifepristone was sufficient.
The FDA-approved regimen for medication abortion includes two drugs: mifepristone, which blocks the hormone progesterone, and misoprostol, which induces contractions.
The fact that the justices delayed Kascmaryk’s decision may be a sign that the majority is inclined to reject the challenge. Only two of the nine justices, conservatives Clarence Thomas and Samuel Alito, dissented.
It’s possible the court could settle the case without delving into the knotty legal issues surrounding the FDA’s approval process. The government argued vigorously that the doctors and others who sued lacked standing because they could not show any harm traceable to the FDA’s decisions.
Doctors do not prescribe mifepristone themselves, but they suggest that they are injured because they may be required to treat patients who take the pill and have serious side effects. Because the plaintiffs were against abortion, any action they were forced to take to complete the process would make them complicit, the plaintiffs argued. court documents.
The FDA’s lawyers wrote in the government’s brief that the plaintiffs could at best present a “hypothetical scenario,” which is insufficient to establish their position.
Petitioners “cannot even identify a single instance in which any of their members were forced to provide such care,” he said.