Justice Department Appeals Texas Judge’s ‘Unprecedented’ Ruling On Abortion Pill

AP: Justice Department Appeals Texas Abortion Pill Order
The Justice Department on Monday appealed a Texas court ruling that would halt approval of a drug used in the most common method of abortion in the U.S., calling the decision “extraordinary and unprecedented. ”If allowed to stand, the order issued last week by U.S. District Judge Matthew Kacsmaryk could restrict access to the abortion medication mifepristone as early as Friday, unsettling abortion providers less than a year after the reversal of Roe v. Wade already dramatically curtailed abortion access. (Weber, 4/10)

Politico: White House Says Ignoring Judge's Abortion Pill Ruling Would Set 'Dangerous Precedent' 
The White House said on Monday that it would be a “dangerous precedent” for the administration to ignore a federal judge’s decision last week blocking the sale of an abortion pill. “But I’ll say this, you know, as a dangerous precedent is set for the court to set aside the FDA’s and expert judgment regarding a drug’s safety and efficiency, it will also set a dangerous precedent for this administration to disregard a binding decision,” White House press secretary Jean-Pierre said at her briefing on Monday. “We are ready to fight this. This is going to be a long fight. We understand this. We stand by FDA approval of mifepristone.” (Frazier, 4/10)

Case could head to Supreme Court —

Roll Call: Legal Fight Over Abortion Drug Could Quickly Hit Supreme Court
The Justice Department and several Democrat-led states took steps Monday to preserve access to a commonly used medication abortion drug after dueling federal court rulings about its availability. The moves come as experts expect fast-paced court action that could easily head to the Supreme Court as soon as this week on the Food and Drug Administration’s approval and regulations of mifepristone, which was first approved in 2000 to end pregnancies. (Macagnone and Raman, 4/10)

The New York Times: Abortion Pill Ruling May Face Headwinds At The Supreme Court 
The conservative legal movement has long had two key goals: to limit access to abortion and to restrict the authority of administrative agencies. The decision last week by a federal judge in Texas invalidating the Food and Drug Administration’s approval 23 years ago of the abortion drug mifepristone checked both of those boxes. The ruling, if it stands, would not only thwart access to the pills, used in more than half of pregnancy terminations, but also undermine the F.D.A.’s authority to approve and regulate other drugs. (Liptak, 4/10)

The Hill: What To Expect As Legal Battle Heats Up Over Texas Abortion Ruling
As the only sitting judge in Amarillo’s federal courthouse, U.S. District Judge Matthew Kacsmaryk, a former attorney at a religious freedom legal group, was guaranteed to be assigned the mifepristone case when it was filed there late last year. A frequent home for challenges brought by Texas Attorney General Ken Paxton (R) and other conservatives, Kacsmaryk previously issued high-profile decisions against the Biden administration that reinstated the Trump-era “Remain in Mexico” policy, curtailed federal protections for LGBTQ workers and ruled against a vaccine mandate. Lawyers have long looked for the best forum to bring their cases, but some legal observers say the way Texas operates its single-judge divisions allows plaintiffs to strategize with striking precision. (Choi and Schonfeld, 4/10)

The Boston Globe: Texas Judge’s Rationale On Abortion Misses The Truth
In his ruling last week, US District Judge Matthew J. Kacsmaryk of Texas cited numerous statistics that suggest mifepristone, one of two drugs used in medical abortions, is unsafe and untested, even though it has been used for more than two decades. Here are six statements from the decision, which attempts to invalidate the FDA’s approval of the drug, that medical experts said are either inflammatory, inaccurate or both. (Bartlett, 4/11)

Response from the drug industry and the FDA —

The New York Times: Pfizer CEO And Other Drug Company Leaders Condemn Texas Abortion Pill Ruling
The pharmaceutical industry plunged into a legal showdown over the abortion pill mifepristone on Monday, issuing a scorching condemnation of a ruling by a federal judge that invalidated the Food and Drug Administration’s approval of the drug and calling for the decision to be reversed. The statement was signed by more than 400 leaders of some of the drug and biotech industry’s most prominent investment firms and companies, none of which make mifepristone, the first pill in the two-drug medication abortion regimen. It shows that the reach of this case stretches far beyond abortion. Unlike Roe v. Wade and other past landmark abortion lawsuits, this one could challenge the foundation of the regulatory system for all medicines in the United States. (Belluck and Jewett, 4/10)

Politico: The Abortion Pill Rulings Are Scaring The FDA And Drugmakers. Here’s Why.
Jane Henney, who was FDA commissioner when mifepristone was approved, said Monday that “this ruling sets a very dangerous precedent for the FDA’s authority in terms of other new medications.” “Clearly, we would be entering totally uncharted territory in that regard,” she said during a call with reporters. ... And William Schultz, former deputy commissioner for the FDA and former general counsel for HHS, said the decision “could allow virtually anyone to challenge any FDA drug approval decision with a good chance of succeeding.” “Any FDA drug approval involves hundreds of judgments by the agency. If a court feels free just to kind of take a fresh look at each of those, there’s a chance that a court will find one of those judgments is wrong,” Schultz said. (Foley, Lim, Messerly and Ollstein, 4/10)

Stat: 6 Burning Questions About FDA's Response To Abortion Pill Decisions
A dueling pair of federal court decisions has thrown the fate of the abortion pill mifepristone into jeopardy  — and have left regulators and drugmakers navigating uncharted territory. The two decisions throw the drug, also used to treat miscarriages, into legal limbo nationwide, regardless of state governments’ abortion protections. They also raise fundamental questions for regulators responsible for overseeing much of the country’s health care, and for the drugmakers that expend time and money to bring countless medicines to the market. (Owermohle and Silverman, 4/11)

Stat: Where Is PhRMA In The Mifepristone Debate?
A judge’s decision to suspend the Food and Drug Administration’s approval of an abortion pill could have massive impacts for the pharmaceutical industry, but its largest lobbying association is staying on the sidelines. (Cohrs, 4/10)

Also —

KHN: Doctors’ Lesson For Drug Industry: Abortion Wars Are Dangerous To Ignore
Texas District Court Judge Matthew Kacsmaryk’s decision April 7 to rescind the approval of the abortion pill mifepristone dealt a blow to more than just people seeking a medication abortion. It appears to be the first time a court has directly usurped the FDA’s authority to provide the final word on which medicines are safe and effective and, thus, allowed to be sold in the United States. And it could well throw the pharmaceutical industry into turmoil. (Rovner, 4/11)

KHN: Watch: Rulings On Abortion Pill Have Far-Reaching Repercussions 
U.S. District Judge Matthew Kacsmaryk, who was appointed by former President Donald Trump, has invalidated the FDA’s two-decade-old approval of mifepristone, part of a drug regimen used in medication abortion. The order will take effect on April 14, unless an appeals court or the U.S. Supreme Court intervenes. In Washington state, U.S. District Judge Thomas Rice, appointed by former President Barack Obama, directed the FDA not to make any changes that would restrict access to the drug in 17 states and the District of Columbia, where Democrats sued to protect its availability. The conflicting rulings are all but assured to wind up before the Supreme Court. (Varney, 4/10)