Following recent rulings on whether  FDA's approval of the abortion pill mifepristone is valid, industry stakeholders have voiced concern that the decision could undermine FDA's authority and turn the drug-approval process "upside down."

Background

On Friday, Judge Matthew Kacsmaryk of the U.S. District Court for the Northern District of Texas  issued a ruling invalidating FDA's approval of mifepristone, arguing the agency didn't adequately review scientific evidence or follow the proper protocols when it approved the drug in 2000.

"F.D.A. acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions," Kacsmaryk said in his ruling. "There is also evidence indicating F.D.A. faced significant political pressure to forgo its proposed safety precautions to better advance the political objective of increased 'access' to chemical abortion."

This ruling seemingly marks the first time a court has ruled to remove an FDA-approved drug from the market.

In  response  to Kacsmaryk's ruling, more than 200 pharmaceutical companies signed a  statement  calling for the reversal of the decision. More than 400 leaders from some of the most prominent companies in the drug and biotech industry criticized Kacsmaryk for issuing the ruling, noting that he has "no scientific training" and warning that the decision has "undermined the bipartisan authority granted by Congress to the Food and Drug Administration to approve and regulate safe, effective medicines for every American."

In addition, "[t]he decision ignores decades of scientific evidence and legal precedent," the drugmakers wrote. "Judge Kacsmaryk's act of judicial interference has set a precedent for diminishing FDA's authority over drug approvals, and in so doing, creates uncertainty for the entire biopharma industry." 

Meanwhile, in a lawsuit filed in Washington state by 18 Democratic attorneys general challenging FDA's restrictions on prescribing and dispensing mifepristone, Judge Thomas Rice blocked FDA from taking "any action to remove mifepristone from the market or otherwise cause the drug to become less available."

On Wednesday, a three-judge panel of the 5th Circuit Court of Appeals overturned part of Kacsmaryk's ruling. In a  42-page order, the federal appeals court allowed mifepristone to remain on the market until the full case was heard on its merits.

However, the appellate panel allowed other parts of the ruling to take effect by a 2-1 vote. The order permits use of the abortion pill for up to seven weeks of pregnancy. Previously, the pill was approved for use up to 10 weeks. The appellate court also ruled that the drug cannot be distributed by mail.

The Biden administration will likely appeal the full decision to the Supreme Court.

These rulings could have a widespread impact

While it is still unclear how the appeals process will unfold, the ruling could have a sweeping impact if it holds. In particular, it could pave the way for additional challenges to drug approvals or regulatory decisions related to other drugs.

According to legal experts, if the Texas ruling is upheld, it could alter the pharmaceutical industry's reliance on FDA's processes for developing new drugs.

"This is a frontal assault on the legitimacy of the F.D.A. and their discretion to make science-based decisions and gold standard approval processes," said Lawrence Gostin, director of the  O'Neill Institute for National and Global Health Law at Georgetown University. "It ultimately takes us on an extraordinarily dangerous path for F.D.A. as an agency, and for science-based public health decision-making more broadly."

Holly Fernandez Lynch, an assistant professor of medical ethics and law at the  University of Pennsylvania, said the Texas ruling is "truly an unprecedented decision." According to Fernandez Lynch, if judges can influence drug approvals, the pharmaceutical industry may opt to "stick to things that aren't going to ruffle any feathers."

"What may happen, if this decision is allowed to stand, is that the industry is going to think, 'Hmm, maybe we shouldn't spend our resources on drugs that could be controversial, that might cause people to take us to court to say that FDA was wrong in approving this drug,'" Fernandez Lynch said.

Ultimately, Henney noted that the Texas ruling is "disappointing" because it not only perpetuates a "very chaotic" message to those seeking abortion care, but also could challenge the validity of FDA's approval process, which she says is the "gold standard" in the United States and the rest of the world.

HHS Secretary Xavier Becerra noted that the Texas ruling has the potential to turn FDA's approval process "upside down."

"When you turn upside down the entire FDA approval process, you're not talking about just mifepristone," Becerra said. "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."

"If that is disrupted, it really causes chaos not just in the marketplace, but chaos for medical providers and patients who need a sound and solid voice of authority to say this has been reviewed, these products are safe and effective," Henney said. (Treisman, NPR, 4/11; Jewett/Belluck, New York Times, 4/11; Bettelheim/González, Axios, 4/10; Owens, Axios, 4/12; Raman, Roll Call, 4/11; Neukam, The Hill, 4/9; Cheney et al., Politico, 4/13; McCammon, NPR, 4/13; Belluck, New York Times, 4/13)

3 ways the abortion pill ruling could impact life sciences 

By Fanta Cherif and Amanda Okaka

Last week's ruling sent shockwaves through legal and regulatory communities alike. Texas' decision to overturn mifepristone's approval is particularly pertinent in a post-Roe era, where thousands of women are already facing limited access to safe abortions and maternal care.

3 potential implications for life sciences

While it is still unclear exactly how the legal battle surrounding this ruling will unfold, there are three significant life sciences implications to consider.

1. It could change the drug-approval process

If upheld, this ruling could set a dangerous precedent that allows judges and courts to undermine FDA's authority to act as the governing body responsible for setting the thresholds for clinical efficacy and safety.

In the ruling, Kacsmaryk claimed that FDA did not have the authority to approve mifepristone, arguing that pregnancy is a "natural process," not an "illness." Ultimately, the ruling could open the door for others to challenge FDA's drug approval process.

2. It could impact other drugs

Although this ruling only applies to mifepristone, it has the potential to impact other products in the future, including those that target illnesses that disproportionately affect birthing persons and people of color. It may also affect products that use natural and living elements — such as biologics and stem cell technologies — like vaccines, drugs for HIV treatment, and more.

The loss of these medications could have far-reaching public health implications, including exacerbating existing health disparities within marginalized groups.

3. It could hinder innovation

Every year, pharmaceutical companies spend billions of dollars on research and development to gain FDA approval for new drugs. However, this ruling makes the trajectory of new drugs entering the market uncertain.

The ruling could slow the pace of innovation if there is no guarantee a drug will remain on the market after it is approved, raising the question of whether the return on investment justifies the costs associated with developing new drugs.

The appeals process is evolving quickly, and it is still unclear exactly how and when this ruling may change the drug approval process. However, safety and efficacy are at the heart of every drug approval. Ultimately, we need to ensure the preservation of a drug approval process that is rooted in scientific evidence — regardless of the outcome of this case.