ACP says governmental interference in evidence-based medicine is ‘extremely problematic’
May 5, 2023 (ACP) — The American College of Physicians is expressing concern with a recent federal court ruling that threatens access to mifepristone, a drug that is widely used for several purposes, including treatment of miscarriage and the termination of pregnancy.
On April 7, Texas federal judge Matthew J. Kacsmaryk ruled against the 23-year-old U.S. Food and Drug Administration approval of the drug. On April 21, the U.S. Supreme Court put the lower court ruling on hold pending further legal proceedings, allowing approval of mifepristone to be kept in place for the time being, but this is a temporary win.
As President Biden noted in a statement, “This does not just affect women in Texas -- if it stands, it would prevent women in every state from accessing the medication, regardless of whether abortion is legal in a state.”
Dr. Ryan D. Mire, immediate past president of the American College of Physicians, noted, “Over its decades of use in this country, mifepristone has been demonstrated to be safe and effective, with an extremely low rate of major complications. ACP strongly believes that prescription drugs used for reproductive health purposes should not be subject to more stringent access or distribution rules than drugs used for other purposes that have comparable safety and risk profiles.”
He added, “Revoking mifepristone's approval would be substituting the legal opinion of a federal judge for the medical and scientific knowledge of experts dedicated to evaluating the safety of pharmaceuticals, setting a troubling precedent. Our patients need to be able to access appropriate, evidence-based medical care, including the full range of reproductive health care services, without undue political interference.”
The Texas judge's ruling comes less than a year after the Supreme Court eliminated the constitutional right to an abortion, allowing states to ban the procedure. According to The New York Times, abortion is now mostly banned in 14 states, and legislatures in several other states are trying to join them. In the most notable recent action, the governor of Florida signed a bill banning abortion after six weeks of gestation. The ban is on hold pending a Florida Supreme Court review, the Times reported.
ACP policy, which was updated earlier this year, notes that mifepristone -- used in more than half of abortions in the United States -- is considered safe and effective. Major complication risks are rare, according to ACP policy, which cites a complication rate of 0.4 percent and a mortality rate of 0.00064 percent with mifepristone.
In the policy paper, ACP adds that “prescription drug policy should allow for distribution and access to medications that is in line with evidence about their utility, safety profile, and risk for complications and is comparable to the allowed access to other medications with comparable profiles.”
Shari Erickson, ACP chief advocacy officer and senior vice president, noted that the Supreme Court decision to put a hold on the Texas judge's mifepristone ruling does not mean that physicians are able to legally prescribe it across the nation for medication abortions. “It's not available in multiple states because they have already essentially banned abortion overall,” she said.
As she noted, “governmental interference that gets in the way of medical evidence is extremely problematic for our physicians and their patients. ACP members are among who will be affected by a ban since internal medicine physicians can and do prescribe mifepristone for their patients.”
ACP is monitoring the legal battle over mifepristone, which now heads to a federal appeals court, Erickson said, noting that ACP stands ready to join friend-of-the-court briefs as appropriate.
ACP is also carefully watching as several state legislatures wrestle with decisions regarding abortion rights. “There are opportunities for our state chapters to engage in advocacy, and we're eager to support them,” Erickson said. “We're here to help them engage and make a positive difference.”