By: Allen Pinn, Coordinator, Policy

In recent weeks, the drug mifepristone has gained national attention. Mifepristone, a drug prescribed for medication abortion, to treat women after miscarriage, and to treat diseases such as some cancers and hypoglycemia, is at the center of ongoing litigation.

Approved over twenty years ago, mifepristone is used in most abortions performed in the United States. On April 7, U.S. District Judge Matthew Kacsmaryk from the Northern District of Texas ruled mifepristone’s Food and Drug Administration’s (FDA) approval be halted, giving the federal government seven days to appeal his decision. In a conflicting ruling, U.S. District Judge Thomas O. Rice from the Eastern District of Washington ruled that the FDA maintain its current availability in 17 states and the District of Columbia.

These conflicting opinions caused widespread confusion among doctors, patients, and reproductive rights advocates on the availability of the drug. Following the Texas ruling, the FDA and Justice Department immediately filed an appeal in the U.S. Fifth Circuit Court of Appeals, where the court issued a stay, ruling mifepristone could remain on the market under strict conditions. These conditions included limiting access to mifepristone to seven weeks gestation instead of ten weeks and banned delivery of the medication through the mail. It also invalidated the FDA’s approval of a generic version of mifepristone.

After the Fifth Circuit’s ruling, in an emergency hearing, the Supreme Court blocked both the Northern District of Texas and U.S. Fifth Circuit Court’s stays and ordered mifepristone remain on the market with broad availability until a decision is reached in the U.S. Fifth Circuit Court of Appeals, which will hear arguments beginning May 17.

What is at stake?

Despite mifepristone being the focus of these cases, the consequences of a previously FDA-approved drug being pulled from the market through the judicial process could have sweeping implications. Experts across the patient advocacy, medical, and drug manufacturing communities believe the removal of mifepristone from the market would set a dangerous precedent undermining the FDA’s authority in regulating the safety of drugs. A decision to reverse the approval could also dissuade drug manufacturers from bringing new drugs/treatments to the market if they fear a court ruling could block an approval, which could impede drug innovation for generations.

How are patient organizations reacting?

In a statement signed by 31 patient and provider groups, including the National Health Council, patient advocates signaled their concerns over the blockage of mifepristone. In part, the statement reads:

“Generations of Americans have trusted the FDA’s expertise. If this judge’s ruling is allowed to stand, patients may no longer have the security of knowing that determinations about drug safety ultimately lie with the experts.”

How are other stakeholder groups reacting?

Below are reactions from other stakeholders.

“The [Northern District of Texas] court’s disregard for well-established scientific facts in favor of speculative allegations and ideological assertions will cause harm to our patients and undermines the health of the nation.”

• • Jack Resneck Jr., MD, President, American Medical Association

“This ruling sets in motion a process to block access to mifepristone, which is used in the treatment of several diseases. This judicial decision on mifepristone could lead other courts to inappropriately block access to other safe and efficacious FDA-approved drugs and treatments.”

• • Council of Medical Specialty Societies (CMSS)

 “[The decision] would set a dangerous precedent for undermining the FDA, has consequences that extend well beyond the single drug,”

• • Biotechnology Innovation Organization (BIO)

“At a time when medical innovation has never been more promising, it is vital we have a legal and policy environment that fosters the development of new treatments and cures and protects patients’ access to the medicines they need. We will continue to explore all policy and legal options to ensure the FDA’s approval authority is protected,”

• • Jim Stansel, Executive Vice President, General Counsel and Corporate Secretary, Pharmaceutical Research and Manufacturers of America (PhRMA)

In an amicus brief filed April 11, dozens of drug manufacturers, executives, and investors, also shared their discontent over the Texas ruling.

“If allowed to take effect, the district court’s decision will result in 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 the pharmaceutical industry,”

In addition to the Texas and Washington lawsuits, GenBioPro, a generic manufacturer of mifepristone, is suing the FDA to prevent any disruption in access to the medication. In their lawsuit, filed in Maryland, GenBioPro argues disruption in access would cause their company great harm and alleges the FDA violated the Due Process Clause of the Constitution in its response to the litigation surrounding mifepristone.

Conclusion

Regardless of the outcome of the U.S. Fifth Circuit Court of Appeals’ decision, the case deciding mifepristone’s FDA approval is expected to reach the Supreme Court. The NHC will continue to monitor any new developments as they arise within the coming weeks.