Abortion rights advocates in the United States filed separate lawsuits Wednesday challenging bans on the abortion pill in two states, opening what is expected to be a long-running dispute over access to the drug.
The lawsuits allege that the drug’s limits in North Carolina and West Virginia conflict with the US Food and Drug Administration (FDA), which has approved the abortion pill as a safe and effective method of ending pregnancy.
The lawsuits were brought by a North Carolina doctor who prescribes the pill, mifepristone, and the company GenBioPro, which makes a brand of the drug and is sued in West Virginia.
Although federal courts challenge state laws, they represent an important test that can ultimately determine abortion access for millions of women. Medicines have recently surpassed medical procedures as the most common abortion method in the US.
The new lawsuit turns on the long-standing principle that federal laws, including FDA decisions, preempt federal laws. Indeed, a few states have tried to ban FDA-approved drugs because of past rulings in the agency’s favor.
But with the fall of Roe v Wade, a constitutional decision that had previously protected abortion as a constitutional right, there is no precedent for modern abortion laws.
After the Supreme Court overturned the ruling in June, previous abortion bans have been accepted and two states have adopted new ones. Currently, abortion restrictions at all stages of pregnancy are enforced in 13 states.
On top of that, 19 states — including North Carolina and West Virginia — have separate laws governing how, when and where doctors can prescribe and administer abortion pills.
“West Virginia cannot ignore the FDA’s determination of safety and effectiveness, nor will it disrupt the market for these drugs,” David Frederick, an attorney representing GenBioPro, said in a statement.
Legal experts foresee years of court battles over access to the pill.
North Carolina bans almost all abortions after 20 weeks, except for medical emergencies. Doctors can only prescribe abortion drugs after government-mandated counseling to their patients and must administer the drugs individually.
The lawsuit – filed by Dr Amy Bryant, a medical and clinical doctor – claims that such requirements conflict with the FDA’s approved labeling for the drug and interfere with its ability to treat patients.
“We know from years of research and use that medication abortion is safe and effective – there is no medical reason for politicians to interfere or restrict access,” Bryant said in a statement issued by the Expanding Medication Abortion Access project, which promotes abortion. a libertarian group working against the government’s constitution.
The office of North Carolina Attorney General Josh Stein, who is being sued as the state’s top prosecutor, is reviewing the complaint Wednesday, spokeswoman Nazneen Ahmed wrote in an email. Stein, a Democrat who announced last week that he is running for governor in 2024, is a supporter of abortion rights.
The FDA approved mifepristone in 2000 to end pregnancy when used in combination with a second drug, misoprostol. The combination is allowed to be used until the 10th week of pregnancy.
For more than 20 years, the FDA has restricted the distribution of these drugs to private offices and hospitals due to safety concerns. In some cases, the combination of drugs can cause excessive bleeding, requiring emergency care.
But since the start of the COVID-19 pandemic, the agency has repeatedly eased restrictions and expanded access, increasing demand even as federal laws make the pill difficult for many women to access.
At the end of 2021, the agency eliminated the requirement to take the pills, saying that new scientific evaluations did not show the number of safety problems if the drug is taken at home. That change also allowed the pill to be prescribed via telehealth and delivered by mail-order pharmacies.
Earlier this year, the FDA also loosened restrictions by allowing brick-and-mortar stores to offer the drug, as long as they receive certification.
This change was made at the request of two drug manufacturers: GenBioPro and Danco Laboratories, which produces a brand of mifepristone called Mifeprex.
In its West Virginia lawsuit, GenBioPro argues that the state’s law interferes with the FDA’s regulations on drugs, which has authority over the approval and regulation of all drugs in the US.
West Virginia prohibits most abortions, except for cases of rape and incest and in life-threatening emergencies and terminal pregnancies. The partial ban, which was signed into law in September, repeals previous laws on access to abortion pills.
“The restrictions and restrictions make it impossible for GenBioPro to sell and distribute mifepristone in West Virginia in accordance with FDA requirements,” the company said in its suit filed in the state’s southern district.
West Virginia Attorney General Patrick Morrisey said he will defend the new abortion law. “Although it may not please the manufacturers of abortion pills, the Supreme Court of the United States has made it clear that the prohibition of abortion is a matter of government,” he said in a statement.
Abortion advocates have filed their own lawsuits seeking to stop the pill’s use, including a Texas suit alleging that the FDA overstepped its authority in approving the pill. Abortion rights groups on Wednesday pledged to support state abortion limits.
“We stand with the people of North Carolina and West Virginia against the reckless pressure of abortion advocates to mandate abortion on demand in every state,” said Marjorie Dannenfelser of the group Susan B Anthony Pro-Life America.
Mifepristone relaxes the cervix and blocks the effects of the hormone progesterone, which is needed for pregnancy. Misoprostol, a drug also used to treat uterine ulcers, is taken 24 to 48 hours later. It causes the uterus to vibrate and vibrate, causing bleeding and uterine contractions.