Restoring Access to Abortion Pills: Challenges to the F.D.A.’s Approval of Mifepristone
In addition, the appeals court sought to roll back rules adopted since 2015 that have facilitated access to abortion pills — among them, rules that allow patients seeking an abortion to obtain the pills by mail and rules allowing telemedicine appointments with doctors. The appeals court wanted to restore some of the rules that were in effect when they were implemented, such as the rule that required three in person appointments for anyone using the drug.
This will surely include challenges to vaccines after three years of politics that were caused by disinformation. Emergency contraception is one of the safest and most effective types of hormonal birth control. Also at risk: drugs used to treat cancer and arthritis that can incidentally affect unexpected pregnancies, drugs to prevent or treat H.I.V., and medications aimed at providing gender-affirming care.
Mini Timmaraju, president of the abortion rights group, said that the continued availability of the drug was crucial and that the fight for abortion rights was not over.
Ms. Healey said the next attack on reproductive freedom was just around the corner. In preparation for the possibility of the pill being pulled from the market, she last week asked the University of Massachusetts to purchase a one-year supply of mifepristone for the state.
While statements of muted celebration poured in from elected Democrats and groups supporting abortion rights, comment from Republicans and anti-abortion groups was noticeably sparser.
Attorney General Andrew Bailey of Missouri, who opposes abortion, said through a spokesman that the decision was a disappointment. In February, Mr. Bailey and Republican attorneys general in 21 states sent letters threatening legal action against Walgreens and CVS pharmacies if they dispensed mifepristone.
Mr. Bailey, who also filed a brief in support of the case against the F.D.A.’s approval of the drug, said he remains “confident in the strength of our case.”
The Alliance Defending Freedom, the conservative Christian legal advocacy organization that is representing the challengers to the F.D.A.’s approval of mifepristone, played down the ruling in a statement.
Representative Diana DeGette, Democrat of Colorado, said the court had “averted a disaster that not only would have put women’s health at risk, but also threatened to upend our nation’s entire drug-approval process going forward.”
Democratic leaders also used the moment to characterize Republicans as extreme. The abortion issue has been politically fraught for the G.O.P., and has been implicated in losses in the upcoming election as well as in a recent State Supreme court race. The party has struggled to reach consensus on policy at both the state and national levels.
The governor of Michigan, a Democrat who recently repealed her state’s 1931 abortion ban, said in a statement that there needs to be a clear reason why the case came before the court.
She said that the anti-abortion extremists would use the courts to push their agenda and they would organize millions of people who believe in safe, legal abortion to fight back.
But the justices, for now, left the case in the hands of the 5th U.S. Circuit Court of Appeals, which has scheduled oral arguments in the case for May 17. The case will most likely end up back at the Supreme Court, with a potential decision in the case next term.
Prescription drug sales in the United States and the Roe v Wade Act (Roe + Wade): Fading the FDA, Not Danco
“I continue to stand by FDA’s evidence-based approval of mifepristone, and my Administration will continue to defend FDA’s independent, expert authority to review, approve, and regulate a wide range of prescription drugs,” Biden said in a statement.
“The stakes could not be higher for women across America. I will continue to fight for women’s health. But let’s be clear – the American people must continue to use their vote as their voice, and elect a Congress who will pass a law restoring the protections of Roe v Wade,” Biden stated.
The appeals court’s view is likely to stay the same after oral arguments. The 42-page preliminary order is based on a law that has not been enforced for many years. In order to prevent the mailing of obscene or lewd materials, and to stop the mailing of drugs used for contraceptives, the statute was enacted in 1873.
The 5th Circuit’s decision would causeregulatory chaos across the country according to the FDA and Danco. As Danco put it in its brief, the result would be “an untenable limbo,” not only for Danco, which could not legally market and distribute its drug, but for the FDA, doctors, health care systems and women, some of whom use the drug when they miscarry.