Ne Colorado News

WASHINGTON -- Congresswoman Yadira Caraveo, M.D. (CO-08) and Congresswoman Kathy Manning (NC-06), both members of the Pro-Choice Caucus, introduced a resolution reaffirming the Food and Drug Administration’s (FDA) authority to approve drugs for abortion care on April 20, 2023.

“For more than two decades, mifepristone has been proven safe and effective for abortion care and miscarriage management. The federal court’s decision to revoke FDA approval of mifepristone replaces decades of scientific evidence with extreme political ideology and strips women across the nation of their ability to access this crucial form of abortion care,” Congresswoman Kathy Manning (NC-06). “If this radical decision is allowed to stand, it will undermine the regulatory authority of the FDA, which was granted to it by Congress nearly eighty years ago. What’s more, it would set the stage for other FDA-approved drugs to be challenged in federal court. I am leading this resolution reaffirming the FDA’s authority to approve abortion care medications – and all medications – to push back on this reckless court decision.” 

Read the full text of the resolution here

.The resolution is endorsed by NARAL Pro-Choice America and the Democratic Women’s Caucus.

The resolution is also cosponsored by: Representatives Grace Meng (NY-06), Jake Auchincloss (MA-04), Nikki Budzinski (IL-13),  Greg Casar (TX-35), Judy Chu (CA-28), Gerald Connolly (VA-11), Jasmine Crockett (TX-30), Chris Deluzio (PA-17), Veronica Escobar (TX-16), Brian Higgins (NY-26), Glenn Ivey (MD-04), Greg Landsman (OH-01), Rick Larsen (WA-02), Gwen Moore (WI-04), Frank Mrvan (IN-01), Wiley Nickel (NC-13), Eleanor Holmes Norton (D-DC), Jimmy Panetta (CA-19), Chris Pappas (NH-01), Brittany Pettersen (CO-07), Katie Porter  (CA-47), Ayanna Pressley (MA-07), Mary Gay Scanlon (PA-05), Andrea Salinas (OR-06), Jan Schakowsky (IL-09), Brad Schneider (IL-10), Emilia Sykes (OH-13), Dina Titus (NV-01), Jill Tokuda (HI-02), Paul Tonko (NY-20), Susan Wild (PA-07), and Nikema Williams (GA-05).

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%.

· 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 19, 2023, Justice Alito issued a further administrative stay of Justice Kacsmaryk’s ruling which extends the deadline to Friday, April 21 at 11:59PM.

Original source can be found here.