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U.S. Federal Courts

Judge’s nationwide abortion pill ban ‘could open the floodgates’

Medicines for gay, bi, and trans Americans could be next

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Judge Matthew Kacsmaryko’s ruling would ban the nationwide sale and distribution of the abortion pill mifepristone. (Screen capture via YouTube)

White House Press Secretary Karine Jean-Pierre told reporters on Monday that last week’s decision by a Texas court to ban the nationwide sale and distribution of the abortion pill mifepristone “could open the floodgates for other medications to be targeted and denied to people who need them.”

Following that ruling by Judge Matthew Kacsmaryk of the U.S. District Court for the Northern District of Texas, American Medical Association President Jack Resneck raised similar concerns in a statement warning that “upending longstanding drug regulatory decisions by the U.S. Food and Drug Administration (FDA)” would position “other drugs at risk of being subject to similar efforts.”

“This ruling makes every medication on the market a potential target for political grandstanding,” Whitman-Walker Institute Executive Director Kellan Baker told the Washington Blade by email.

“Now that Judge Kacsmaryk has decided that he knows more about medical evidence than the FDA, the entire foundation of the FDA’s essential role in safeguarding access to medications is now subject to political attack,” Baker said.

“You’re not talking about just mifepristone,” U.S. Department of Health and Human Services Secretary Xavier Becerra said during an appearance on CNN’s “State of the Union” Sunday. “You’re talking about every kind of drug. You’re talking about our vaccines. You’re talking about insulin. You’re talking about the new Alzheimer’s drugs that may come on.”

Likewise, in an interview on Pod Save America that aired Tuesday, law professor Leah Litman agreed drugs like HIV medications, along with vaccines like those targeting HPV and COVID, or birth control pills, could be next.

Medicines for trans youth and adults, in some cases, have been targeted with legislation passed by conservative states to restrict access to guideline directed medically necessary interventions for the treatment of gender dysphoria.

And last year, another Texas court ruled that employers can deny health coverage for PrEP, a medication used to prevent the transmission of HIV.

More litigation lies ahead, along with more uncertainty

Ruling in Alliance for Hippocratic Medicine v. FDA, Kacsmaryk had issued a stay on the Food and Drug Administration’s conclusion that mifepristone is safe and effective, a finding the agency reached in 2000 that has since been buttressed by more than two decades of clinical evidence.

It was roundly denounced as unscientific, the product of the judge’s longstanding and well documented ideological opposition to abortion.

The Biden administration was prepared for Kacsmaryk’s decision, Jean-Pierre said: Attorney General Merrick Garland immediately pledged the Justice Department to appeal and seek a stay (of Kacsmaryk’s ruling) pending the outcome of additional litigation. And then on Monday the Department asked the U.S. Court of Appeals for the Fifth Circuit to halt implementation of the ruling.

Other powerful legal actors had also been on notice. On Monday, New York Attorney General Letitia James led a coalition of state attorneys general in challenging Kacsmaryk’s ruling with an amici brief filed to the 5th Circuit.

Casting additional uncertainty into the mix was a separate ruling, just hours after Kacsmaryk’s, by Judge Thomas Rice of the U.S. District Court for the Eastern District of Washington, who ordered the FDA to make no changes to the availability of mifepristone.

The case in Washington was brought by attorneys general from 17 states and the District of Columbia in anticipation of Kacsmaryk’s ruling, and the split decision means the matter is likely to be settled by the U.S. Supreme Court.

Some legal observers have speculated that the Biden administration may be pushing for this outcome, hedging that even with its 6-3 conservative supermajority the justices are likely to reject Kacsmaryk’s analysis of the relevant facts on substantive or procedural grounds.

Still, and notwithstanding the fate of other medications or vaccines in the hands of Kacsmaryk or his ideological allies on the federal bench, the Texas court’s ruling raises other major questions.

For example, can a federal judge circumvent the congressionally ordained power of America’s federal administrative agencies? If so, under which circumstances? How about the practice of forum shopping, by which litigants deliberately move to have their cases adjudicated by judges they expect will be most sympathetic? And what will all of this uncertainty mean for the global biopharmaceutical industry and the future of drug discovery in America?

One solution that was proposed by at least two Democratic members of Congress, Rep Alexandria Ocasio-Cortez (N.Y.) and Sen. Ron Wyden (Ore.): the Biden administration should simply ignore Kacsmaryk’s ruling.

“I believe the Food and Drug Administration has the authority to ignore this ruling, which is why I’m again calling on President Biden and the FDA to do just that,” Wyden said in a statement Friday.

“If they don’t,” warned the senator, “the consequences of banning the most common method of abortion in every single state will be devastating.”

“The courts rely on the legitimacy of their rulings, and what they are currently doing is engaging in an unprecedented erosion of their legitimacy,” Ocasio-Cortez told Anderson Cooper during an interview on CNN Friday.

On Twitter, the congresswoman addressed the backlash against her comments, explaining that Republicans have also ignored court orders in cases where they felt they were unlawful.

On Monday, the White House circulated an open industry letter signed by more than 200 pharmaceutical industry executives, which echoed criticisms of Kacsmaryk’s ruling that noted his lack of formal education or training in science or medicine.

The executives’ letter also argued the decision presents systemic risks to the drug discovery pipeline.

“As an industry we count on the FDA’s autonomy and authority to bring new medicines to patients under a reliable regulatory process for drug evaluation and approval,” the group wrote.

“Adding regulatory uncertainty to the already inherently risky work of discovering and developing new medicines will likely have the effect of reducing incentives for investment, endangering the innovation that characterizes our industry.”

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U.S. Federal Courts

DOJ to ask Supreme Court to halt courts’ mifepristone restrictions

Texas judge, 5th Circuit ruled against abortion drug

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U.S. Supreme Court (Washington Blade photo by Michael Key)

The Justice Department is expected to ask the U.S. Supreme Court to halt a pair of rulings by a federal court in Texas and a federal appellate court in New Orleans that would restrict the sale and distribution of the abortion pill mifepristone.

Last week, Judge Matthew Kacsmaryk of the U.S. District Court for the Northern District of Texas issued a stay of the U.S. Food and Drug Administration’s approval of the drug 23 years ago, effectively barring its sale and distribution nationwide.

The 5th U.S. Court of Appeals ruled late Wednesday night that access to the drug would not be prohibited pending the outcome of litigation in the case, Alliance for Hippocratic Medicine v. FDA.

However, in the meantime the appellate court preserved other restrictions on mifepristone from Kacsmaryk’s ruling including the prohibition of distributing the medicine by mail or prescribing its FDA approved generic equivalent and requiring that it be prescribed only after three in-person visits with a healthcare provider, and only up to seven weeks of pregnancy.

“The Justice Department strongly disagrees with the 5th Circuit’s decision in Alliance for Hippocratic Medicine v. FDA to deny in part our request for a stay pending appeal,” U.S. Attorney General Merrick Garland said in a statement on Thursday.

“We will be seeking emergency relief from the Supreme Court to defend the FDA’s scientific judgment and protect Americans’ access to safe and effective reproductive care,” Garland said.

“We are going to continue to fight in the courts, we believe the law is on our side, and we will prevail,” White House Press Secretary Karine Jean-Pierre told reporters early Thursday during President Joe Biden’s trip to Ireland.

The Supreme Court typically acts on such requests in a matter of days, often without explanation.

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U.S. Federal Courts

Federal appeals court preserves access to abortion drug

The Court also set tighter rules for accessing mifepristone

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A courtroom for the U.S. 5th Circuit Court of Appeals in the John Minor Wisdom United States Courthouse in New Orleans, Louisiana. (Carol M. Highsmith, photographer, Library of Congress Prints and Photographs Division)

A three judge panel of the 5th U.S. Circuit Court of Appeals issued a ruling Wednesday just before midnight in New Orleans that has preserved access to the abortion drug mifepristone.

In a 2-1 vote the panel blocked the lower court ruling by Judge Matthew Kacsmaryk of the U.S. District Court for the Northern District of Texas for now, but set tighter rules that would allow the drug only to be dispensed up to seven weeks into pregnancy, not 10, and not by mail.

In his ruling in Alliance for Hippocratic Medicine v. FDA, Kacsmaryk had issued a stay on the Food and Drug Administration’s conclusion that mifepristone, which is used in combination with a second drug, misoprostol, is safe and effective, a finding the agency reached in 2000 that has since been buttressed by more than two decades of clinical evidence. Kacsmaryk’s ruling had been on pause for a week to allow the U.S. Justice Department to file the appeal with the 5th Circuit Court.

U.S. Attorney General Merrick Garland immediately ordered the Justice Department to appeal and seek a stay (of Kacsmaryk’s stay) pending the outcome of additional litigation. On Monday the Department asked the U.S. Court of Appeals for the Fifth Circuit to halt implementation of the ruling.

The Associated Press reported that under the appeals court order, the FDA’s initial approval of mifepristone in 2000 is allowed to remain in effect. But changes made by the FDA since 2016 relaxing the rules for prescribing and dispensing mifepristone would be placed on hold.

Those include extending the period of pregnancy when the drug can be used and also allowing it to be dispensed by mail, without any need to visit a doctor’s office.

The AP also reported that the two 5th Circuit judges who voted to tighten restrictions, Kurt Engelhardt and Andrew Oldham, are both appointees of former President Donald Trump. The third judge, Catharina Haynes, is an appointee of former President George W. Bush.

Haynes said she would have put the lower court ruling on hold entirely temporarily to allow oral arguments in the case.

The decision by the 5th Circuit’s 3 judge panel can still be appealed to the U.S. Supreme Court.

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U.S. Federal Courts

DOJ asks 5th Circuit to halt abortion pill ban ruling

Pharmaceutical industry has slammed Texas judge’s decision

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U.S. Attorney General Merrick Garland (Screen shot/CSPAN)

The Justice Department on Monday asked the 5th U.S. Court of Appeals to halt Friday’s ruling by a Texas judge that will suspend the nationwide sale and distribution of the abortion medication mifepristone.

The move follows Attorney General Merrick Garland’s statement on Friday in which he said the department “strongly disagrees with the decision of the District Court for the Northern District of Texas in Alliance for Hippocratic Medicine v. FDA and will be appealing the court’s decision and seeking a stay pending appeal.”

Judge Matthew Kacsmaryk’s ruling “overturns the FDA’s expert judgment, rendered over two decades ago, that mifepristone is safe and effective,” Garland said, adding the department “will continue to defend the FDA’s decision.”

The White House on Monday circulated an open industry letter signed by more than 200 pharmaceutical company executives that objects to the issuance of a mifepristone ban by “a federal judge with no scientific training” who had “fundamentally undermined the bipartisan authority granted by Congress to the Food and Drug Administration to approve and regulate safe, effective medicines for every American.”

The letter explains the harms and risks to the biopharmaceutical industry that will stem from Kacsmaryk’s ruling and the precedent it may set:

“As an industry we count on the FDA’s autonomy and authority to bring new medicines to patients under a reliable regulatory process for drug evaluation and approval. Adding regulatory uncertainty to the already inherently risky work of discovering and developing new medicines will likely have the effect of reducing incentives for investment, endangering the innovation that characterizes our industry.”

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