(Opinion) Nurse practitioners support the role of the FDA

FDA should regulate medications without interference from the courts

The ruling by federal district Judge Matthew Kacsmaryk of Texas suspending the Food and Drug Administration’s approval of mifepristone, one of two medications used in medication abortion in the U.S., 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 by millions of individuals worldwide over the past 23 years. Mifepristone was 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, 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 NH Nurse Practitioner Association (NHNPA), representing the state’s 2,500 advanced practice registered nurses (APRNs), also supports the Supreme Court decision. NHNPA has concerns about the case and a court decision that would impact access to the drug and compromise the FDA’s authority.

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.

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 do not want to see additional drug shortages or a lack of innovation.

NHNPA is concerned that these potential court actions could also cause patients to worry about access to lifesaving medications, and that medical professionals will be hampered in providing care to patients. Decisions preventing, continuing or terminating a pregnancy should be made solely by patients in consultation with their healthcare professional. We support nurse practitioners’ ability to provide 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.

After the Supreme Court’s Dobbs decision, which 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 court limiting or negating the FDA’s approval of mifepristone will have far-reaching implications not limited to abortion.

At a time when there are workforce and other challenges for patients, providers and healthcare systems, we see no value or merit to the courts attempting to dismantle areas where science and practice are undisputed.

Joyce Cappiello, APRN, lives in Barrington; Nancy Wilson, APRN (retired), lives in Concord; and Sarah Bay, APRN, lives in Peterborough.

Categories: Opinion