Colorado advocates praise FDA decision allowing abortion medication in pharmacies

Reproductive rights advocates in Colorado were feeling optimistic following the U.S. Food and Drug Administration’s decision to expand access to the abortion pill mifepristone in early January — but a federal lawsuit filed just 10 days after the decision, which completely challenges the FDA’s approval of the drug in 2000, has made the future of medication abortions uncertain. 

The FDA on Jan. 3 issued a decision that allows the abortion drug mifepristone to be picked up at a pharmacy if the patient has a prescription, eliminating a previous requirement that the drug be given directly from a health care provider. Mifepristone is approved for a medication abortion up to 10 weeks gestation when taken with a second drug, misoprostol. Prescribing providers and participating pharmacies would need to meet certain qualifications, so not every pharmacy would be equipped with the drug. 

Dr. Kristina Tocce, medical director at Planned Parenthood of the Rocky Mountains, said the FDA’s decision is a “really big breakthrough” to increase access and normalize medication abortions across the country. 

“You’re able to pick up these medications in a pharmacy as you are any other prescribed medicine,” Tocce said. “That’s a big statement.”

Colorado has already allowed medication abortions through telehealth appointments and mailing abortion medication to patients, which Tocce said was particularly helpful during the peak of the COVID-19 pandemic. She said providing medication abortions through telemedicine has been thoroughly studied and published, showing it is a safe and effective means of abortion care. 

Tocce said she hopes to see the new FDA rules reduce the general demand for services that expanded-access states like Colorado have exerpienced since the Dobbs decision last year, when the U.S. Supreme Court overturned the federal right to an abortion established by Roe v. Wade. She said it could be a “game changer” for patients seeing long wait times given the time sensitivity of abortion care, and the limited number of states protecting access.

“This will be a great thing for patients, especially patients that are remote from offices that typically carry mifepristone, and anything we can do in this at this time to increase access to abortion care is going to have tremendous impacts on the entire state, the entire country,” Tocce said. 

América Ramirez, program director for the Colorado Organization for Latina Opportunity and Reproductive Rights, said it’s exciting to see expanded access and agreed it could be beneficial for people across the state, especially the Latina community. But, she said the fact that pharmacies need to opt in and go through certification processes to have the drug on hand could make it more challenging, since not all local pharmacies will do this.

“I think a lot of folks are really going out of their way to find any means to be able to find this service, this form of health care for themselves,” Ramírez said. “So of course there’s always going to be folks that try to find the loopholes and the ways in which it fits best for them in terms of their affordability and accessibility.”

U.S. Rep. Diana DeGette, a Denver Democrat who co-chairs the Congressional Pro-Choice Caucus, said during a recent press conference with news reporters that the caucus is working with the Biden administration to ensure the U.S. Postal Service will be able to deliver abortion medications when prescribed by an out-of-state doctor. 

Karen Middleton, president of Cobalt, a Colorado-based reproductive rights advocacy organization, said the FDA’s decision will be particularly beneficial for Coloradans outside of the Denver metro area, so long as their pharmacies are willing to participate. But, she said while this is a positive step forward, there are still too many “bureaucratic and cost barriers” for those seeking abortion care.

“We’ve known for years that medication abortion care is overwhelmingly safe and effective,” Middleton said in an email. “We hope that Colorado pharmacies, especially in rural areas, will make it available to patients as soon as possible and without bureaucratic delay.”

Federal lawsuit brings future into question

Now that several anti-abortion groups worked to get a lawsuit challenging the FDA’s approval of mifepristone in front of a federal judge, who was appointed by former President Donald Trump, reproductive rights advocates are frustrated to see such an unprecedented questioning of the FDA’s authority. The legal fight is viewed as likely to go all the way to the Supreme Court. 

The lawsuit argues that the FDA “exceeded its regulatory authority” in approving the use of mifepristone and misoprostol to end a pregnancy and seeks a preliminary and permanent injunction that would remove the FDA’s approval of the two drugs for a medication abortion. Attorneys for the U.S. Justice Department have said there are no other examples in history where a court second-guessed a safety and efficacy determination from the FDA. 

Middleton said this lawsuit was the only choice for anti-abortion activists, as she said they “know that they’ll lose at the ballot box” since five states voted to protect abortion rights in 2022. 

“That’s why these radicals are bringing legal challenges in states residing in conservative circuit court districts — they know it’s their best chance to weaponize the legal system to buck support of abortion access,” Middleton said. “Americans support access to abortion care, including making medication abortion more available. A small minority of anti-abortion extremists are trying to go against the will of the voters with these lawsuits, and we hope voters will continue to see through that.” 

Fawn Bolak, a spokesperson for Planned Parenthood of the Rocky Mountains, called the lawsuit a “politically-motivated attack” that has “no basis in science,” as the drug has been used safely and legally since its initial approval by the FDA more than 20 years ago. They said this plan was designed to push abortion care further out of reach for millions seeking it.

“Exploiting the legal system in an attempt to prevent people from accessing safe, essential health care is unconscionably cruel,” Bolak said in an email. “Rest assured PPRM will continue to provide safe and legal abortion care to our patients — no matter the outcome in this case.”