by Joyce Cappiello, New Hampshire Bulletin
The ruling by federal district judge Matthew Kacsmaryk of Texas suspending the Food and Drug Administration (FDA) approval of mifepristone, one of two medications used in medication abortion in the United States, began another round of assaults on reproductive health and rights.
The ruling stated that mifepristone, used for medication abortion, among other uses, was unlawfully approved in September 2000, claiming the FDA did not adequately consider the drug’s safety. Mifepristone has been used safely and effectively by millions of individuals in the United States and worldwide over the past 23 years. Mifepristone was intensely researched before approval and is found as safe as aspirin after two decades of use. Neither scientific research nor surveillance have questioned the safety of the drug.
On April 13, a federal appeals court in Louisiana ruled that partial access to mifepristone could continue until the U.S. Supreme Court decided the case. On April 21, the Supreme Court granted a stay, which preserves full access to mifepristone as the court considers the request to intervene. Later that day, New Hampshire Gov. Chris Sununu expressed his support of the Supreme Court decision with a tweet, “Good call by the Supreme Court” in response to the Associated Press’s tweet, “The Supreme Court has preserved access to the drug used in the most common method of abortion, rejecting lower-court restrictions while a lawsuit challenging its FDA approval continues.”
The New Hampshire Nurse Practitioner Association (NHNPA), representing the state’s 2,500 advanced practice registered nurses (APRNs), also supports the Supreme Court decision.
As the lawsuit challenging mifepristone continues, NHNPA has serious concerns about the case and a court decision that would impact access to the drug and compromise the authority of the FDA. As a starting point, we respect the role and authority of the FDA to approve and regulate safe, effective medications, including mifepristone, which has been legal since September 2000. The FDA’s approval of mifepristone more than two decades ago was “based on a thorough and comprehensive review of the scientific evidence presented” as it was determined mifepristone was “safe and effective for its indicated use.”
We fully support the role of the FDA in regulating new and existing medications without interference from the courts. As highlighted by the Kaiser Family Foundation, there is a little-known fact that mifepristone, under the brand name Korlym, was approved by the FDA in 2012 to manage blood sugar levels (hyperglycemia) in adults with endogenous Cushing’s syndrome.
Will the courts also restrict the use of mifepristone for patients with this syndrome who now rely on it daily? The court’s interference in an area of science they know little about is alarming.
Further, suppose the courts, rather than the FDA, could remove drugs from the market for reasons other than scientific data. The court’s actions would diminish the regulatory authority of the FDA, allowing long-standing drugs such as mifepristone or other drugs deemed unsuitable for political or cultural reasons to be removed from the market. If the courts regulate drugs, the unstable environment will limit new drug development. We already have a shortage of new antibiotics in the regulatory pipeline; we do not want to see additional drug shortages or a lack of innovation.
NHNPA is concerned that these potential court actions could also unnecessarily cause patients to worry about access to potentially lifesaving medications and that we, as medical professionals, will be hampered in providing the highest level of evidenced-base care to our patients.
As in all health care matters, decisions regarding preventing, continuing, or terminating a pregnancy should be made solely by patients in consultation with their health care professional. The mission of the NHNPA regarding reproductive rights is to sustain the right of nurse practitioners to provide high-quality reproductive health care with respect to patient autonomy and scope of practice. We support nurse practitioners’ ability to provide full access to reproductive care and high-quality maternal health care. In addition, NHNPA advocates for nurse practitioners to work toward decreasing maternal mortality and eliminating disparities in maternal health.
In the aftermath of the U.S. Supreme Court’s Dobbs decision, which effectively dismantled the 50-year-old right to an abortion, and as many states have imposed tighter restrictions or enacted near-total bans on abortion, a decision by the Supreme Court limiting or negating the FDA’s approval of mifepristone will have far-reaching implications not limited to abortion. This dangerous precedent will impact the FDA’s role in our health care system and create unintended consequences.
At a time when there are workforce and other challenges for patients, providers, and health care systems, we see no value or merit to the courts attempting to dismantle areas where science and practice are undisputed.
This story was written Joyce Cappielli, Nancy Wilson, and Sarah Bay, all of whom are nurses and contributors to the New Hampshire Bulletin, where this story first appeared.
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