![]() "It would mean that any FDA regulatory or approval decision could be subject to the whims of a single federal court or state," Gostin said. "You can't have individual states let alone a single judge overturning all of the scientific evidence that's assessed by the federal Food and Drug Administration and usurping that power for itself," said Gostin, who has advised the Biden administration in the past on health policy. It would have "disastrous" consequences and set a "cataclysmic" precedent, he said. Lawrence Gostin, an expert on public health law at Georgetown Law, said it would be "highly irresponsible" and "reckless" for a judge to overturn the FDA approval of mifepristone. "If longstanding FDA drug approvals were so easily enjoined, even decades after being issued, pharmaceutical companies would be unable to confidently rely on FDA approval decisions to develop the pharmaceutical-drug infrastructure that Americans depend on to treat a variety of health conditions," the Biden administration lawyers wrote. It would put more women's health at risk and cause overcrowding and delays at clinics that provide surgical abortion, they wrote in their response.Ī decision by the court to overturn the FDA's approval could also harm future drug development, the government's lawyers said. The public interest would be "dramatically harmed" by pulling mifepristone from the market, the government lawyers argued. Decades of experience from thousands of women and their physicians has confirmed mifepristone is safer than surgical abortion or childbirth, they said. The FDA determined that mifepristone is a safe and effective way to end an early pregnancy more than two decades ago based on extensive scientific evidence, the agency's lawyers wrote. The FDA, in its response filed earlier this month, described the lawsuit as "extraordinary and unprecedented." The government's lawyers said they could not find any previous example of a court second-guessing an FDA approval and removing a widely available drug from the market. They contend pregnancy is not an illness, mifepristone is not more safe and effective than surgical abortion, and claim the FDA's actions have put patients' health at risk. In their complaint, the anti-abortion physicians argue the FDA abused its power by approving mifepristone through an accelerated process which is reserved for new drugs that would benefit patients with serious or life-threatening illnesses more than what's currently available. ![]() From there, the case could end up at the Supreme Court. If the alliance wins in federal district court, the Biden administration would appeal to the 5th Circuit in New Orleans, a conservative court with 12 of its 16 active judges appointed by Republicans. District Court for the Northern District of Texas in 2019. Kacsmaryk was appointed by former President Donald Trump to the U.S. Judge Matthew Kacsmaryk is hearing the challenge to the FDA's approval of the abortion pill. Jackson Women's Health Organization case that ultimately resulted in the Supreme Court abolishing federal abortion rights. The Alliance for Hippocratic Medicine is represented by the Alliance Defending Freedom, a Christian organization that played a central role in the Dobbs vs. The court could issue a ruling as soon as Feb. The FDA's powers to approve drugs would also be weakened. would lose access, at least temporarily, to the most commonly used abortion method. ![]() If the lawsuit prevails, women across the U.S. The case has thrust the FDA in the middle of the fierce national battle over abortion access in the wake of the Supreme Court's decision to overturn Roe v. Personal Loans for 670 Credit Score or Lower Personal Loans for 580 Credit Score or Lower ![]() Best Debt Consolidation Loans for Bad Credit
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