If the justices take up the case, they could hear oral arguments early next year and issue a decision by late June 2024, influencing fall elections.
On Thursday, Oct. 12, a wide range of organizations filed 14 amicus curiae briefs supporting a Justice Department petition asking the U.S. Supreme Court to overturn a Fifth Circuit decision imposing nationwide limits on access to the abortion pill mifepristone. Supporting the government’s appeal were reproductive rights organizations, medical and legal experts, patient advocacy groups, 257 members of Congress, 23 states and D.C., over 600 state legislators, state and local governments and officials, and pharmaceutical industry representatives, including GenBioPro, which makes a generic form of mifepristone.
“This legal attack on medical abortion has no basis in law or fact,” said GenBioPro CEO Evan Masingill. “Decades of science support mifepristone’s safety and efficacy. GenBioPro firmly believes that all people, regardless of income, gender, race or geography, have a right to access evidence-based healthcare and safe and effective medicines, and that includes medical abortion.”
Mifepristone has been safely used by over 5 million women in the United States over the last 23 years, and today is used in more than half of all abortions in the U.S.
The case began last November when a group of anti-abortion doctors and a dentist filed a lawsuit challenging the FDA’s approval of mifepristone in 2000.
In early April 2023, Matthew Kacsmaryk—a Trump-appointed federal judge in Amarillo, Texas—ruled the FDA improperly approved mifepristone back in 2000 and ordered the medication off the market.
Five days later, on emergency appeal, the Fifth Circuit Court of Appeals issued a preliminary injunction allowing mifepristone to remain on the market but severely restricting access while the case was on appeal. Within days, the Department of Justice filed an emergency appeal to the Supreme Court.
On April 21, the Supreme Court blocked the Fifth Circuit injunction from taking effect, allowing mifepristone to remain on the market under current rules until a final decision in the case.
After a controversial hearing on the case where Fifth Circuit judges demonstrated remarkable bias against the government, the Court of Appeals released a decision on Aug. 15, dismissing the challenge to the U.S. Food and Drug Administration’s 2000 approval of mifepristone, but overruling subsequent FDA decisions increasing access to mifepristone. The ruling, which remains on hold until final review, would sharply restrict access to medication abortion nationwide and eliminate telemedicine abortion.
Mifepristone has been safely used by over 5 million women in the United States over the last 23 years, and today is used in more than half of all abortions in the U.S.
In early September, the Justice Department filed an appeal—Food and Drug Administration v. Alliance for Hippocratic Medicine—arguing that the Fifth Circuit ruling was riddled with legal errors and, if allowed to go into effect, would have significant “destabilizing practical consequences.”
“The Fifth Circuit countermanded a scientific judgment FDA has maintained across multiple administrations; imposed unnecessary restrictions on the distribution of a drug that has been safely used by millions of Americans over more than two decades; and upset reliance interests in a healthcare system that depends on the availability of mifepristone as an alternative to surgical abortion for women who choose to lawfully terminate their early pregnancies,” argued the Justice Department brief.
The State Innovation Exchange’s Reproductive Freedom Leadership Council (RFLC) filed an amicus brief on behalf of 603 state legislators from 49 states, describing the devastating impact the Fifth Circuit decision would have on people in their states. RFLC members North Carolina state Rep. Julie von Haefen and Minnesota state Sen. Erin Maye Quade led their fellow state lawmakers in submitting the brief.
“The type of pregnancy care someone gets shouldn’t depend on whether they live in a blue state or red state, but that’s exactly the reality we’re living in,” said Quade. “The case before the Supreme Court brings the effort to ban abortion to Minnesota and could override Minnesotans’ legal and constitutional right to make healthy decisions about our own bodies–and hinder our ability to provide care for both Minnesotans and those traveling from restrictive states for abortion care. We simply can’t afford yet another blow to the patchwork of abortion access nationwide.”
“In North Carolina, people already face barriers to access abortion care,” said von Haefen. “The last thing we need in any state is to make it even more difficult to get a safe and effective medication that millions have relied on for decades to safely end a pregnancy. The Supreme Court must step in to say, ‘No more.’”
Pharmaceutical Research and Manufacturers of America argued that the Fifth Circuit’s decision would undermine drug development and innovation:
“The Fifth Circuit’s ruling threatens to stifle pharmaceutical innovation by disrupting industry’s reasonable investment-backed expectations. Congress created an FDA approval process that is both rigorous and thorough, and pharmaceutical companies invest billions of dollars in research and development to meet FDA’s scientific standards … But if every FDA drug approval decision—and subsequent supplemental drug approval decision—can be retroactively invalidated by a court based on extra-statutory, judicially created requirements, biopharmaceutical companies will likely invest less in the advancement of new and existing medicines that benefit patients.”
In short, absent review by this Court, the Fifth Circuit’s decision threatens a seismic shift in the clinical development and drug approval processes.”
Brief of pharmaceutical companies, executives and investors
The brief of pharmaceutical industry representatives emphasized the importance of regulatory clarity and stability for the drug approval process:
“[The Fifth Circuit’s] imposition of new and unwarranted restrictions on [FDA’s] decision making processes, threatens to destabilize countless FDA approval decisions. This additional uncertainty would make the already high degree of risk in [pharmaceutical industry] investments intolerable. And without necessary investment, drug development would freeze, stifling innovation and limiting treatment options for patients. … In short, absent review by this Court, the Fifth Circuit’s decision threatens a seismic shift in the clinical development and drug approval processes—erecting unnecessary and unscientific barriers to the approval of lifesaving medicines, chilling drug development and investment, threatening patient access, and destabilizing FDA’s rigorous, well-established, and long-standing drug approval process, which is rooted in science and law.”
Patient advocacy organizations highlighted the devastating effect of the Fifth Circuit decision for patients across the country suffering from serious medical conditions:
“The potential negative ramifications of this [decision] are vast. If FDA’s risk-benefit assessments are vulnerable to the kind of short-sighted challenges and second guessing at the root of the Respondents’ claims, and validated by the decision below, the resulting uncertainty about the ongoing authoritativeness of FDA’s approval process will cause grave harm to patients. The decision risks needed treatments suddenly becoming unavailable, resulting in physical harm and psychological turmoil. Patients will also be less likely to benefit from innovative treatments made possible by new drugs and new indications of use. Why? Because this new, unprecedented uncertainty about the reliability of FDA approval disincentivizes drug manufacturers from making the huge investments of funds in research and development and manufacturing required to bring to market cutting-edge drugs and improved therapies that benefit patients.”
The opposition has until Nov. 9 to file response briefs in the case. If the justices take up the case, they could hear oral arguments early next year and issue a decision by late June 2024, which would likely factor into the fall elections.
Up next:
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