Greensboro Reporter

Washington, D.C. – Congresswoman Kathy Manning (NC-06), Policy Co-chair of the Democratic Women’s Caucus and member of the Pro-Choice Caucus, released the following statement after the U.S. Supreme Court announced their decision to stay Judge Kacsmaryk’s ruling, keeping mifepristone available while the underlying case is considered in the U.S. Court of Appeals.

“This decision will allow mifepristone to remain available while the U.S. Court of Appeals Fifth Circuit considers the underlying case. I’m relieved – women who need this medication can continue to access it for the time being - but our fight is not over,” said Congresswoman Manning. “We will not rest until the courts and Congress reaffirm the FDA’s authority to approve medications, including those used for abortion.

“Earlier this week, I introduced a resolution to reaffirm the FDA’s authority to approve medications used for abortion care. I call on my congressional colleagues to pass my resolution immediately to clarify the FDA’s authority and maintain confidence in the drug approval process. No judge’s political ideology should be allowed to replace scientific facts.”

Background:

• In 1938, the Food, Drug, and Cosmetic Act (FDCA) was signed into law, authorizing the FDA to oversee, regulate, and approve new drugs and medical devices.
• In 1962, the Kefauver-Harris Amendments to the FDCA were signed into law, charging the FDA with the authority to approve drugs that were established by manufacturers through a comprehensive scientific review process to be proven safe and effective. Since then, the FDA has approved nearly 19,000 prescription drugs for marketing.
• In 2000, the FDA approved the use of mifepristone for medical abortion following a nearly 5-year review process.
• In August of 2008, an audit of the approval and oversight of mifepristone by the Government Accountability Office found that the approval of the medication was consistent with the approval and oversight of other medications.
• Mifepristone has been used by more than 5 million people and is used in more than half of abortions nationwide. There is overwhelming evidence that medication abortion is safe and effective for virtually anyone who wants to end an early pregnancy, with a safety record of over 99%.
• On April 7, 2023 District Court Judge Matthew Kacsmaryk issued an opinion rescinding the FDA’s 2000 approval of mifepristone. He stayed his decision for one week to allow time for appeal.
• More than 400 executives from pharmaceutical and biotech companies, none of which make mifepristone, have raised concern over these court rulings, stating: “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.”
• Judge Kacsmaryk’s ruling undermines public confidence in the authority of the FDA’s regulatory process, resulting in confusion over the safety of medications on the market.
• On April 13, 2023, the United States Court of Appeals Fifth Circuit ruled that the abortion drug mifepristone can remain on the market but reverted back to the standard set before 2016 which effectively prohibits its use beyond seven weeks of pregnancy and bars its distribution by mail.
• On April 19, 2023, Justice Alito issued a further administrative stay of Justice Kacsmaryk’s ruling which extended the deadline to Friday, April 21 at 11:59PM.

Original source can be found here.