FDA drug regulations challenged by anti-abortion campaign


Some states seek to block access to approved drugs.

The recent Supreme Court decision revoking the legal right to abortion services in the United States (Dobbs v. Jackson Women’s Health Organization) has reinforced efforts by some states to also limit patient access to certain government-approved drugs and treatments. the FDA. A primary target is mifepristone (Mifeprex), approved by the FDA over 20 years ago as a safe and effective way to block progesterone production. Taken in combination with a second drug, misoprostol (Cytotec), in the first 10 weeks of pregnancy, this medical treatment stops a pregnancy.

More than half of abortions in the United States are induced by these drugs, now also available in generic form. As more states ban abortion services of all types, a major battle is expected over the legality of states blocking access to these FDA-approved drugs. In response, Attorney General Merrick Garland recently claimed that states cannot ban the drug because of a disagreement with the FDA’s expert judgment. Garland also said the Justice Department stands ready to work with legal authorities to “protect and preserve access to reproductive care.”

FDA approval of mifepristone (also known as RU-486) ​​has been controversial from the start. Manufacturer Danco Laboratories, a small private company, markets only this one product, which gained FDA approval in 2000 despite strong opposition from right-to-life groups at the time. The agency has released several labeling updates over the years and licensed a generic version of GenBioPro in 2019. The FDA too required Danco to implement a Risk Assessment and Mitigation Strategy (REMS) which limited prescribing to certain qualified doctors and required the administration of the pill in the office.

However, the FDA relaxed REMS requirements for mifepristone in 2021 to allow its telemedicine prescription and mail-order delivery of the drug during the pandemic. This added flexibility will be a target when at some point the public health emergency declared by COVID ends and abortion haters seek to roll back previous FDA prescribing and dispensing limits in all states.

Meanwhile, with more than 25 states banning abortions altogether or set to adopt such policies, efforts have already intensified to limit access to mifepristone more broadly. Biden administration officials have challenged these measures, and manufacturers such as GenBioPro have challenged a Mississippi law that blocks access to mifepristone telehealth. Reproductive health advocacy groups are also putting systems in place to help women in states that ban all abortions access these treatments. However, the campaign against medical abortions will only intensify as more states enact laws specifically preventing doctors from prescribing the drug, as recently proposed in Texas.

Brakes for plan B and cancer treatment

A similar confrontation is emerging over access to the “morning after” emergency contraceptive pill, Plan B One Step and several other brands. These drugs, which are not considered abortifacients, are approved to prevent pregnancy when taken within three days of unprotected sex and are available from pharmacies without a prescription. There was a noticeable increase in demand for these pills following the Supreme Court ruling, as many patients sought to stock up on what they feared would become a banned product. While the morning after pills work by blocking ovulation for several days, opponents of abortion claim that the pills also prevent egg implantation and should therefore be limited as causing early abortions.

Even more alarming for the health care community are the challenges related to contraceptives widely used by outspoken right to life advocates. Justice Clarence Thomas shed light on the issue when he issued an opinion in the Dobbs case urging the Supreme Court to “reconsider” past rulings on the right to contraception and other practices seen as undermining family relationships. Such proposals may have the additional impact of blocking efforts to gain FDA approval of non-prescription status for birth control pills and strengthening requirements for health insurers to cover contraceptives without additional cost sharing. .

Equally troubling to medical professionals is the possibility that certain drugs approved for cancer or other serious conditions could harm the fetus or cause miscarriage when needed to treat a pregnant woman, increasing the risk of prosecution under strict abortion bans. The American Association for Cancer Research (AACR) recently raised concerns that state legislation could limit access to cancer care for patients diagnosed during pregnancy, even to protect the life of the mother. The AACR is concerned that intensive care may be denied to patients in some states where it could also compromise fetal development.

The legal battle over states’ right to bar access to FDA-approved drugs is set to escalate, with more than 20 states already planning or enforcing limits on the prescription and use of mifepristone. To avoid taking action that could be challenged in court, some states with strong anti-abortion laws may take steps to limit the use of a drug to induce an abortion, but not impose an outright ban. FDA approved products.

About the Author

Jill Wechsler is the managing editor in Washington for BioPharm International.


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