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U.S. President Joe Biden delivers a speech during a reception celebrating Nowruz in the East Room of the White House in Washington March 20, 2023.

Kevin Lamarque | Reuters

President Joe Biden signed legislation Monday requiring the Office of the Director of National Intelligence to release information about possible links between a laboratory in China and the origins of the Covid-19 pandemic.

The House and Senate unanimously passed the law earlier this month. The push to release classified information about the origins of the pandemic comes after the Department of Energy concluded with “low confidence” that the virus was likely the result of an accidental lab leak in China.

“In implementing this legislation, my administration will release and share as much of this information as possible, consistent with my constitutional authority to protect against disclosure of information that would harm national security,” Biden said in a statement.

Under the legislation, National Intelligence Director Avril Haines has 90 days to release any information on possible links between the Wuhan Institute of Virology and the origins of Covid. The Wuhan Institute of Virology has been a major center of coronavirus research.

The Federal Bureau of Investigation has also concluded that the pandemic likely started with a laboratory incident in Wuhan, China, the agency’s director Christopher Wray told Fox News earlier this month.

“The FBI has held for some time that the origins of the pandemic are most likely a potential laboratory incident in Wuhan,” Wray told Fox News. “You’re talking about a potential leak from a Chinese government-controlled laboratory.”

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The Wall Street Journal first reported the Department of Energy’s assessment, citing people who had read a classified report. White House national security adviser Jake Sullivan would neither confirm nor deny the report, but said Biden has specifically requested that the Department of Energy’s national labs participate in a review of the onset of the pandemic.

The pandemic started three years ago in Wuhan, China, although how Covid spread to people is not yet known. Intelligence agencies were divided in a 2021 report commissioned by Biden that reviewed information about the origins of the pandemic. Intelligence agencies agreed that both an infected animal and a laboratory accident were plausible hypotheses.

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Four unnamed authorities concluded with low confidence in the 2021 report that an infected animal transmitted the virus to humans.

A recent analysis by international scientists found raccoon dog genetic material in samples from the Huanan Seafood Wholesale Market that tested positive for Covid. Although the analysis does not prove that the raccoon dogs were infected with the virus, it does provide some additional data consistent with a possible spread of the virus from animals to humans.

The scientists drew the samples from an international database. The samples subsequently disappeared from this database. The World Health Organization asked Beijing on Friday to release these samples.

“This data could – and should – have been shared three years ago,” said WHO Director Tedros Adhanom Ghebreyesus. “We continue to urge China to be transparent in sharing data and to conduct the necessary investigations and share the results.”

The Alliance For Hippocratic Medicine wants Judge Kacsmaryk to nullify the FDA’s medical approval of mifepristone, which would effectively ban the abortion pill in the US.

Senate Judiciary Committee | youtube

A Texas judge is about to issue a crucial ruling in a closely watched case challenging the Food and Drug Administration’s approval of the abortion pill mifepristone.

The lawsuit, brought by a group of anti-abortion doctors called the Alliance for Hippocratic Medicine, is an unprecedented case, and Judge Matthew Kacsmaryk of the US Northern District of Texas could rule in a number of ways.

He could order the FDA to take mifepristone off the US market entirely. It’s also possible that Kacsmaryk could instruct the agency to tighten access to mifepristone, but not stop selling it entirely. The judge could also rule in favor of the FDA, but the anti-abortion groups would appeal.

Kacsmaryk told attorneys involved at the hearing in Amarillo on Wednesday that he would issue his decision “as soon as possible.”

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Abortion rights groups and legal experts expect the judge will rule against the FDA in some way. Kacsmaryk joined the court in 2019 after being appointed by former President Donald Trump. His nomination was unanimously rejected by both Senate Democrats and Maine Republican Susan Collins over concerns about his views on abortion and LGBTQ rights.

Wendy Davis, senior advisor at Planned Parenthood Texas Votes, told reporters at a news conference Wednesday that abortion rights activists are preparing for the worst.

A court order blocking the sale of mifepristone would have the greatest impact in states where abortion remains legal, said Carrie Flaxman, who is leading the lawsuit at the Planned Parenthood Federation of America.

Rachel Rebouche, a reproductive health law expert at Temple University, said an order blocking sales would create confusion as there will be further litigation over whether such an order is legal.

Possible disposal

If Kacsmaryk issues an order to take mifepristone off the market, there are several ways to make such a decision. The impact of his decision will depend on the language of the order and FDA’s response.

“There are many ways the court can bring about a ruling in our favor,” said Erik Baptist, who represents the Alliance for Hippocratic Medicine in the case and is senior counsel at the Alliance Defending Freedom, another anti-abortion group.

Baptist told reporters during a Thursday news conference that the judge could overturn the FDA’s approval immediately or direct the agency to initiate proceedings to remove mifepristone from the US market.

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“But how the court proceeds with respect to the timetable — effective immediately, effective in 30 days, that too is at the court’s discretion,” Baptist said.

Rebouche said it’s possible for the judge to issue a decision directing the FDA to begin the process of withdrawing mifepristone while suspending the drug from the market while the agency conducts that process.

Quick roll call

If Kacsmaryk issues an order to withdraw mifepristone immediately, the Biden administration would ask him to stay the decision pending its appeal, said Harvard health law expert Glenn Cohen. If Kacsmaryk refuses, the administration will take the case to the US 5th Circuit Court of Circuits.

“My guess is that the residence papers have already been drafted. Someone will take them to court within hours of the decision,” said Cohen, who was previously an attorney with the Justice Department’s civil division.

Cohen, Rebouche and 17 other drug law experts told Kacsmaryk in a court-filed filing in support of the FDA that ordering an immediate withdrawal of mifepristone would violate federal law.

The authority to withdraw a drug rests with the FDA commissioner, who makes that decision based on scientific evidence of the drug’s safety and effectiveness, they said. The manufacturer, in this case Danco Laboratories, should also make itself heard in the process.

“The FDA would argue that the court cannot retract the drug — the FDA must retract the drug, and the court is barred by federal statute from retracting the drug,” Rebouche said.

The FDA could drag out the process

If Kacsmaryk decides against immediately withdrawing mifepristone and instead directs the FDA to begin its formal process to withdraw the drug from the market, the agency can use the process to block it, provided it doesn’t suspend approval during that time .

“Withdrawing a drug from the market when the FDA follows these procedures takes months if not years, so the FDA may try to lengthen the process a little longer to keep the drug on the market in the meantime.” , said Allison Whelan, an FDA law expert at Georgia State University.

“The FDA doesn’t like having its scientific expertise and legitimacy questioned,” said Whelan, who also signed the motion in court in support of the FDA.

Mifepristone off label

The agency also has enforcement discretion, under which it can choose not to prosecute companies that sell unapproved drugs, Whelan said. Mifepristone is also approved to treat a condition called Cushing’s syndrome. Some clinics may choose to prescribe the pill off-label for abortions, she said.

And mifepristone is used in a two-drug regimen with another drug called misoprostol. Baptist, of the Alliance Defending Freedom, told reporters during Thursday’s news conference that the lawsuit only seeks approval for mifepristone.

Misoprostol is recommended by the World Health Organization as a standalone method of terminating pregnancy. Although the FDA has not approved misoprostol as a standalone abortion drug, clinics plan to use this pill as an alternative to mifepristone.

The American College of Obstetricians and Gynecologists recommends misoprostol as an alternative for early abortions when mifepristone is unavailable, although it’s not as effective as the two-drug regimen, according to the organization.

Stricter restrictions

Kacsmaryk could also stop halting mifepristone sales and instead direct the FDA to impose tighter restrictions on the drug’s distribution.

In January, the FDA permanently removed the requirement that patients must receive mifepristone in person from a certified healthcare provider. This enabled telemedicine appointments and mail delivery of mifepristone.

The Alliance for Hippocratic Medicine has asked the judge to reinstate FDA restrictions that have been reversed over the years, arguing that an 1873 federal law called the Comstock Act bans the sending of abortion drugs through the mail.

Rebouche said the Comstock Act hasn’t been enforced in decades, but there’s a possibility the judge could try to revive the statue to force the FDA to re-impose requirements that patients receive mifepristone in person.

Correction: Allison Whelan is an FDA law expert at Georgia State University. In an earlier version, the name of the school was given incorrectly.

Abortion rights supporters gather in front of the J Marvin Jones Federal Building and Courthouse on March 15, 2023 in Amarillo, Texas.

Moises Avila | AFP | Getty Images

A federal judge in Texas this week heard arguments for the first time in a closely watched case challenging the Food and Drug Administration’s approval of mifepristone.

Wednesday’s hearing in Amarillo was open to the public but was not broadcast live.

Judge Matthew Kacsmaryk of the US Northern District of Texas in Amarillo heard arguments for four hours. The anti-abortion group that filed the lawsuit, the Alliance Defending Freedom, first presented its case against the FDA. They were followed by Justice Department attorneys who defended the FDA, and then abortion pill maker Danco Laboratories.

The Alliance Defending Freedom argued that mifepristone was unsafe and the FDA did not properly follow its approval process when clearing mifepristone for use in 2000. The Justice Department strongly denied these claims, arguing that the FDA used its Congressional-approved powers to approve a drug it determined is safe and effective.

Download a full copy of the hearing transcript here.

“This court will issue a decision and an opinion as soon as possible,” Kacsmaryk said at the end of the hearing.

Erik Baptist, Alliance Defending Freedom’s top attorney, told the judge he had the authority to order the FDA to begin its internal process to withdraw a drug from the market, but argued that such action would be inappropriate in this case because it the case could last “many years”.

Instead, Baptist argued that the court could “of its own accord” order the FDA to withdraw the drug, rather than relying on the agency to initiate its internal procedures to do so.

“Any relief you grant, Your Honor, must be complete. The plaintiffs’ scope of this relief must be universal and nationwide,” Baptist told the judge.

Kacsmaryk asked Baptist to explain why the court had such “broad authority.” Baptist said the court has the authority to “take all measures necessary to prevent harm.” The judge also asked Baptist if he could point to another case where a court had withdrawn a drug that has been on the market for more than 20 years.

“My answer to your question is no, I can’t,” Baptist said, although he argued that this was because the FDA had denied previous requests to withdraw mifepristone and impose tighter restrictions.

Julie Straus Harris, a Justice Department attorney, said the statute of limitations prevented plaintiffs from challenging the FDA’s 2000 approval of mifepristone. Harris argued that the public interest would be “irreparably harmed” by an order to take mifepristone off the market.

“An injunction would cause significant harm to the public and deprive patients and physicians of a safe and effective drug that has been on the market for more than two decades,” Harris said. She argued such an order would upend the status quo and harm patients, physicians and the pharmaceutical industry’s reliance on FDA approvals.

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Kacsmaryk sparked controversy ahead of oral arguments after the Washington Post reported that he had tried to keep news about the hearing’s timing private. Citing death threats and harassment, Kacsmaryk told lawyers involved in the case that “less publicity is better” during a conference call last week, according to a court transcript.

The court finally relented and announced the date Monday after media outlets, including NBCUniversal News Group, which owns CNBC, filed a letter criticizing the move as “unconstitutional.”

“The court’s attempt to delay notification and thereby the ability of the public, including the press, to attend Wednesday’s hearing is unconstitutional and undermines the important values ​​served by public access to court proceedings and court records,” he wrote to Peter Steffensen of Southern Methodist University’s Dedman School of Law on behalf of the media.