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A Nevada drug manufacturer is on the front lines in the battle over abortion pills

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Across the country, legal battles are brewing over medication abortion. In the nine months since the Supreme Court overturned Roe v. Wade, the “abortion pill”—which is actually a combination of the drug mifepristone followed by a second pill, misoprostol, approved for abortions within the first 10 weeks of pregnancy—has been critical for patients who live in states where it has been outlawed.

As of 2020, medication abortion is the method used in more than half (53%) of all “facility-based” abortions in the country, according to a census of known providers by Guttmacher Institute, a nonprofit leading research on abortion data.

Since the Dobbs decision in June 2022 that overturned the constitutional right to abortion under Roe, more than a dozen states have enacted bans or restrictions on abortion, taking away legal pathways for millions of patients.

However, the mailing of prescribed medication abortion remains legal under federal law, despite Republican attorneys general who have said it violates laws in states with abortion bans.

Jennifer Oliva, a University of California law professor and scholar in food and drug policy, says the policy patchwork has created a chaotic legal landscape for all parties.

“We’ve never been in a more complex, dicey situation for providers, patients, pharmacies, drug manufacturers [where] everybody is litigating all kinds of things [that were] triggered by the Dobbs decision,” she explains.

That’s what Las Vegas-based company GenBioPro has done in West Virginia. The manufacturer of generic mifepristone filed a lawsuit in January, claiming that West Virginia’s abortion ban violates the Constitution’s commerce clause and supremacy clause (which gives the Food and Drug Administration authority over states to regulate drugs). According to a GenBioPro spokesperson, the company has seen a 100% decline in generic mifepristone sales in nine states with abortion bans or with no abortion clinics in operation.

“GenBioPro was founded out of a deep conviction that all people, regardless of income level, race, sex or geography are entitled to the benefits of evidence-based medicine and state-of-the-art medication,” reads a statement from GenBioPro CEO Evan Masingill. “We have sought to make mifepristone more accessible through commercializing the first FDA-approved generic version of the medication. And, consistent with our commitment, we are challenging laws in the state of West Virginia that in effect ban mifepristone, a drug that is safe and effective and which Congress and FDA have subjected to a specific regulatory regime.”

West Virginia Attorney

General Patrick Morrissey in February filed a motion to dismiss GenBioPro’s lawsuit, asserting that the state’s abortion law did not ban mifepristone and allows for the use of the drug in cases of legal abortion—“rape, incest or to protect the life of the mother.”

Attorneys general from 21 conservative states have joined an Arkansas-led amicus brief defending West Virginia’s abortion law, claiming federal approval of a drug does not preempt state laws restricting the drug.

In a statement to the Weekly, Democracy Forward, which is representing GenBioPro in the West Virginia litigation, acknowledges that its legal battle is playing out alongside a suit against the FDA in Texas District Court.

“GenBioPro’s marketing of mifepristone is regulated by the FDA. GenBioPro has long been dedicated to making evidence-based medication available for those who need it and is committed to continuing to lawfully making its product available and accessible,” reads a statement from president and CEO of Democracy Forward Skye Perryman. “GenBioPro is not a party to the Texas litigation but is monitoring the matter. GenBioPro has no plans to discontinue marketing of its product and will continue to abide by FDA’s guidance.”

MEANWHILE, IN TEXAS

Oliva has joined 18 other food and drug law scholars in an amicus brief in an Amarillo, Texas District Court case that could trigger a dramatic aftershock to abortion access following 2022’s initial round of bans.

The case Alliance for Hippocratic Medicine v. FDA was filed in November 2022 by a group of anti-abortion physicians and organizations represented by the Alliance Defending Freedom, which played a key role in the Dobbs case. It seeks to reverse the FDA’s approval of mifepristone based on claims that the agency “failed” to follow scientific and legal protocols for safety.

In its legal response, the FDA has denied the accusation that it accelerated the testing and approval process for mifepristone.

The food and drug law scholars’ “friend of the court” brief argues that the plaintiff’s motion “mischaracterizes FDA’s drug approval process,” and that enjoining would “destabilize the drug approval process far beyond the context of mifepristone’s approval.”

“No judge has ever enjoined an approved drug from interstate commerce in the history of the United States,” Oliva tells the Weekly. “And the concept that a group of folks with moral objection to abortion [can] go in and challenge the science here and be successful is really mind-boggling.”

Approved by the FDA in 2000, mifepristone has been found to be safer than Viagra and penicillin. After completing a review in 2021, the agency determined it was safe to remove the in-person dispensing requirement for the drug, allowing the abortion pill to be dispensed via mail and at retail pharmacies.

The FDA has since outlined a process for retail pharmacies to become certified to dispense abortion medication. Several pharmacies including CVS, Rite Aid and Walgreens have announced the intent to become certified.

“The confounding thing there is the FDA has repeatedly found over the last 23 years, on numerous occasions that the drug is safe for its intended use, and the benefits grossly outweigh the risks,” Oliva says, adding that plaintiffs’ arguments have not met the expected standards for challenging the agency’s approval of a drug.

Some reports have suggested the Texas case could have “immediate” impact on the availability of medication abortion, even in states where abortion is legal, but Oliva says the FDA would have to follow a process prescribed in statute for reversing approval of a drug.

Final arguments for the Texas case were heard on March 15. The FDA has said it would file and appeal an emergency stay if an injunction is granted in the case, Oliva says.

CONSEQUENCES FOR REPRODUCTIVE HEALTH CARE

What does all this legal turmoil mean for patients’ understanding of and access to safe abortion care and miscarriage management options?

Bans on medication abortion can “jeopardize” providers’ ability to treat patients who have miscarriages, says Dr. Bill Powell, senior medical scientist for Ipas, an international organization focused on increasing access to abortion and contraception. In addition to medical abortion, mifepristone is also used for miscarriage management and other medical diagnoses including “missed abortion.”

“Each of these diagnoses can be treated by other abortion procedures … but then these medical procedures require specific equipment, skilled health care providers, and supportive facilities as well,” Powell said in a partial statement.

In the event that mifepristone is unavailable, abortion providers may use misoprostol only—an approved and “nearly as effective” method that can have more side effects than the two-pill combo, Powell says. “One difference with misoprostol-only is that it can take longer. And for some people, there can be more pain, and more bleeding because of the lengthened time, which is why the combination is preferable.

“That said, given enough time, the efficacy is nearly the same as the combination method.From our perspective, the key is to have a safe abortion—and pills can provide that, even without mifepristone,” he says.

As patients and providers follow the legal twists and turns, Democratic state attorneys general have filed a “countersuit” to the one in Amarillo, Texas. On February 24, Nevada Attorney General Aaron Ford signed onto the multistate lawsuit against the FDA, “for excessively burdensome regulation, despite ample evidence that the drug, mifepristone, is safer than Tylenol.” The suit asks the court to remove the requirement for pharmacies to get certified to prescribe mifepristone, and the requirement for patients and providers to sign an agreement that is then stored in medical records.

“Democratic attorneys general are really concerned about patient privacy. If someone goes out of state … from Mississippi to California and does this, this gets put in their electronic health record, and then their home state of Mississippi somehow [getting] access to that record,” Oliva explains, adding that the Health Insurance Portability and Accountability Act (HIPAA) doesn’t fully protect patients from law enforcement or courts accessing medical records.

The American College of Obstetricians and Gynecologists says the restrictions “do not make care safer; are not based on medical evidence or need; create barriers to clinician and patient access to medication abortion and medical management of early pregnancy loss; and disproportionately burden communities already facing structural barriers to care, including people of color and those living long distances from a health care professional.”

At press time, the multistate attorney generals’ suit was scheduled for a hearing in Washington District Court on March 28.

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Shannon Miller

Shannon Miller joined Las Vegas Weekly in early 2022 as a staff writer. Since 2016, she has gathered a smorgasbord ...

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