The Washington Post described how drug companies and venture capital firms have mobilized in opposition to the lower court rulings restricting access to mifepristone, saying that weakening the FDA’s powers to approve drugs could threaten the regulatory underpinnings of the U.S. drug industry.
“While we may be talking about mifepristone today, we must understand that political motives could similarly attack many innovative and lifesaving biotherapeutics such as genetic medicines, cell therapies and even today’s major advancements in mRNA vaccine technology,” Reid Huber, a partner at Third Rock Ventures, a health care venture capital firm with offices in Boston and San Francisco, said in an email to the Post.
The Pharmaceutical Research and Manufacturers of America, among the most powerful industry lobbying groups in Washington, filed an amicus curiae brief to SCOTUS on Friday that harshly criticized the rulings by Kacsmaryk and the 5th Circuit, saying they posed a threat to the regulatory foundations of the U.S. drug industry.
The fight over drugs
The Biden administration and the Pharmaceutical Research and Manufacturers of America have been at odds over drug prices, but in this case find themselves on the same side. The FDA and New York-based Danco Laboratories, which makes and markets brand-name mifepristone, have asked the Supreme Court to put a stay on the lower courts’ rulings to restrict access to the abortion pill.
The Pharmaceutical Research and Manufacturers of America brief said:
“PhRMA members have a significant interest in maintenance of the status quo during the resolution of the pending appeal, in order to protect against disruptions to the significant investments in drug development. The district court’s analysis threatens to derail the development and approval of new drugs because it departs from the statutory framework created by Congress for FDA’s drug approval process, and is an unprecedented assault on FDA’s approval decisions.”
The brief noted that Pharmaceutical Research and Manufacturers of America members have invested nearly $1.1 trillion since 2000 in research and development for new treatments and cures, including $102.3 billion in 2021 alone. The Pharmaceutical Research and Manufacturers of America added in its filing:
“Biopharmaceutical companies make enormous investments in drug development based on the reasonable expectation that once a drug product is approved finally by FDA under the statutory standards, barring emerging scientific data, it will be lawful and profitable to sell that product for an extended period in the United States.”
Amicus briefs raising similar arguments were filed by the Biotechnology Innovation Organization, the other major industry trade group, and GenBioPro, the maker of the generic version of mifepristone.
more briefs, more problems
On Tuesday, a group of anti-abortion doctors, the Alliance for Hippocratic Medicine, filed an amicus curiae brief asking the Supreme Court to reinstate Kacsmaryk’s decision that suspended FDA approval of mifepristone. The alliance was the plaintiff in the lawsuit and deliberately filed in the Amarillo court so it could be heard by Kacsmaryk, an anti-abortion zealot.
The Washington Post quoted from the brief:
“For nearly a quarter-century,” the anti-abortion doctors said in their filing on Tuesday, the FDA and the manufacturer of mifepristone “have brazenly flouted the law and applicable regulations, disregarded holes and red flags in their own safety data, intentionally evaded judicial review, and continually placed politics above women’s health.”
“Both the Fifth Circuit and district court orders paint an alarming picture of this lawlessness—all to the detriment of the women and girls FDA is supposed to protect.”
Another amicus curiae brief, filed by Americans United for Life on Tuesday, had the signatures of 147 GOP members of Congress, including 23 senators and 124 House members. It asked the high court to allow the lower court ruling revoking the FDA’s approval of mifepristone to stand.
Democratic Sen. Patty Murray of Washington responded with a statement that read:
“I am astounded by my Republican colleagues’ cruel disregard for women’s right to control their own bodies, their eagerness to defy the American people by asking a court to deny patients access to an FDA-approved drug, and their complete indifference to how overruling the FDA’s experts with an unprecedented ruling by a sole federal district court would upend the agency’s authority to do its job and threaten patients’ ability to get so many other critical medications.”
Murray was among the lead signers of an amicus brief filed on Friday by 253 Democratic members of Congress—50 senators and 203 House members—asking the Supreme Court to stay Kacsmaryk’s order.
which side is the supreme court on?
So will the Supreme Court side with Big Pharma or the religious right? One option would be to further whittle down the restrictions imposed by the lower courts. The justices could simply ban the distribution of mifepristone by mail while the legal process goes on. Such a decision could avoid involving the FDA, but would instead be based on an obscure and largely ignored 1873 federal law, the Comstock Act, which banned mailing items related to sex and reproductive health.
Kacsmaryk’s judicial overreach puts to the test a key element of the Dobbs ruling, which found that it’s not appropriate for “unelected members of this Court” to “overrule the democratic process” and set national abortion policy. Judge Brett Kavanaugh, in a concurring opinion, wrote:
“This Court will no longer decide the fundamental question of whether abortion must be allowed throughout the United States through 6 weeks, or 12 weeks, or 15 weeks, or 24 weeks, or some other line,” Kavanaugh wrote. “Instead, those difficult moral and policy questions will be decided, as the Constitution dictates, by the people and their elected representatives through the constitutional processes of democratic self-government.”
And that’s how things were playing out in the states until Judge Kacsmaryk in his Amarillo, Texas, courtroom usurped the FDA’s authority and banned mifepristone nationwide.
Medication abortions now account for more than half the abortions in the U.S., up from 39% in 2017, according to The Guttmacher Institute, an abortion rights advocacy and research group. Guttmacher, in late February, reported that the two-drug abortion medication regimen—mifepristone followed by misoprostol—is legal in 22 states and Washington, D.C., and in 15 other states must be prescribed by a doctor, not other clinicians.
At the time, 13 states—with the strictest abortion bans—had already banned medication abortions: Alabama, Arkansas, Idaho, Kentucky, Louisiana, Mississippi, Missouri, Oklahoma, South Dakota, Tennessee, Texas, West Virginia, and Wisconsin. Wyoming has subsequently enacted a medication abortion ban, and Republicans in Iowa have introduced legislation banning medication abortion, according to Planned Parenthood.
Meanwhile, Planned Parenthood said blue states such as California, New York, and Connecticut have been moving to increase access to medication abortion. And to make things even more complicated, blue states obtained a conflicting order just hours after Kacsmaryk’s ruling from U.S. District Judge Thomas Rice, an Obama-appointee, in Washington state who ruled that the FDA must keep mifepristone available in 17 states and Washington, D.C., where abortion remains legal.
The concerns of the pharmaceutical industry over Kacsmaryk’s ruling go far beyond the abortion issue. There’s a well-established legal process for dealing with drugs that may be considered unsafe—and that is to file a class-action lawsuit seeking damages from pharmaceutical companies. Just consider the multi-billion lawsuits against Purdue Pharma regarding abuse of its anti-pain opioid medication OxyContin.
But the anti-abortion groups didn’t pursue that tried-and-true approach because there really was no basis for forcing the FDA to withdraw its approval for mifepristone on the grounds that the medication was unsafe. Data analyzed by CNN shows that mifepristone is even safer than some common, low-risk prescription drugs, including penicillin and Viagra.
Instead they went judge shopping and brought their case to Kacsmaryk, who, before his appointment to the federal bench, was deputy counsel for the First Liberty Institute, a deeply conservative religious liberty law firm based in Plano, Texas.
first ruling to invalidate an approved FDA drug
The New York Times wrote that legal scholars said the Texas ruling appeared to be the first time a court had tried to invalidate the approval of a drug over the FDA‘s objection. Kacsmaryk’s ruling was also condemned by President Joe Biden and Vice President Kamala Harris, members of Congress, abortion rights groups, doctors, and former Department of Justice and FDA officials.
But one of the most scorching criticisms of Kacsmaryk’s decision came on April 10 in a statement quickly put together and signed by more than 400 leaders of the drug and biotech industry’s most prominent companies and investment firms. They wrote:
”The decision ignores decades of scientific evidence and legal precedent. Judge Kacsmaryk’s act of judicial interference has set a precedent of diminishing FDA’s authority over drug approvals, and in so doing, creates uncertainty for the entire biopharma industry. …
“Judicial activism will not stop here. If courts can overturn drug approvals without regard for science or evidence, or for the complexity required to fully vet the safety and efficacy of new drugs, any medicine is at risk for the same outcome as mifepristone.”
Among the signatories to the statement was Pfizer CEO Albert Bourla, whose company manufactured the first COVID-19 vaccine authorized by the FDA and the anti-viral medication Paxlovid. MSNBC legal analyst Lisa Rubin wrote that Bourla has primarily donated to anti-abortion Republican candidates, including Senate Minority Leader Mitch McConnell and House Speaker Kevin McCarthy. But now Pfizer and other drug companies find themselves in “an unexpected alliance with the reproductive justice movement.”
If the Supreme Court were to allow a judge to force the FDA to revoke the approval of a medication as safe as mifepristone, consider the Pandora’s Box that could be opened. Would such a precedent encourage anti-vaxxers to file a lawsuit asking the court to ban COVID-19 vaccines? After all, the FDA did apply emergency use authorization to allow distribution of the Pfizer-BioNTech COVID-19 vaccine in December 2020, and also has a special emergency program to move new coronavirus therapies such as Paxlovid to patients as quickly as possible. Just imagine the circus that would ensue if plaintiffs tried to prove that COVID vaccines were not safe.
If anti-vaxxers wanted to go judge-shopping, there’s always Judge Kacsmaryk in Amarillo. In fact, right now, Kacsmaryk presides over a lawsuit filed by anti-vaxxers led by Robert F. Kennedy Jr. that accuses some of the world’s top news media organizations of working with social media platforms to censor publications spreading right-wing conspiracy theories. (Disclosure: Robert Kennedy Jr. is currently suing Daily Kos to reveal the identity of a community member who criticized his appearance in Berlin at a rally heavily attended by neo-Nazis. The case is currently in appeals in New York.)
And in December 2021, Kacsmaryk granted a preliminary injunction requested by Texas Attorney General Ken Paxton to block a federal mandate that health care workers at facilities participating in the Medicare and Medicaid programs must be vaccinated against COVID-19.
