Bloomberg Law
Free Newsletter Sign Up
Login
BROWSE
Bloomberg Law
Welcome
Login
Advanced Search Go
Free Newsletter Sign Up

Abortion Pill Access to Ease With First FDA-Certified Pharmacy

Jan. 3, 2023, 11:52 PM

A California-based online pharmacy is the first officially certified to dispense medication abortion under new requirements unveiled Tuesday.

The FDA approved a new pharmacy certification plan developed by Danco Laboratories and GenBioPro, the brand-name and generic manufacturers of the abortion pill mifepristone, the two companies announced.

Honeybee Health—which in 2020 became the first mail-order pharmacy to ship mifepristone after the agency relaxed some restrictions during the pandemic—can now dispense the drug permanently under a revised safety program.

The certification requirements provide an outline for pharmacies to help ensure continued access to the drug to patients across the country seeking to terminate an early pregnancy, especially as states have implemented laws banning or severely restricting abortions since the Supreme Court’s decision in June to overturn Roe v. Wade.

“Doing this really important work has meant a lot to us at HoneyBee, and I’m excited for the rest of the pharmacy community to be able to do this as well,” Jessica Nouhavandi, co-founder of HoneyBee, said in an interview.

“The more pharmacies that are certified, the more access there will be,” she said.

Honeybee said it has developed the technology to achieve an average six-hour turnaround for filling mifepristone prescriptions, with an average of 36 hours between when HoneyBee receives the prescription to when it’s delivered to a patient. Nouhavandi said the company’s infrastructure served as a model to help GenBioPro and Danco develop the new rules, which include that pharmacies certified by Danco or GenBioPro may only dispense mifepristone directly to patients upon receipt of a prescription from a certified prescriber.

“They pretty much know our whole workflow, how we vet providers and make sure that they’re certified, and how we store this type of information,” Nouhavandi said.

GenBioPro CEO Evan Masingill said in a statement that the FDA’s approval “expands access to medications that are essential for reproductive autonomy and is a step in the right direction that is especially needed to increase access to abortion care.”

“GenBioPro looks forward to working with prescribers and pharmacies to increase access to medical abortion care for all people,” Masingill added.

Risk Evaluation Part of the Program

Since the Food and Drug Administration first approved mifepristone in 2000, the use of abortion pills has steadily climbed among medical providers, and accounted for 54% of all US abortions two years ago, according to the Guttmacher Institute. According to Nouhavandi, Honeybee has serviced mifepristone prescriptions for more than 50,000 patients since 2020. Since the Supreme Court’s ruling in June, the number of prescriptions filled at HoneyBee has increased by 30% each month, she said.

“All the news around SCOTUS really was a mechanism for more people to learn that abortion medication is an option,” Nouhavandi said.

Mifepristone, together with another medication called misoprostol, can be used to end a pregnancy within 70 days of a person’s last menstrual cycle, before the end of the first trimester. Mifepristone is subject to a risk evaluation and mitigation strategy (REMS), a drug safety program that the FDA can use to make sure the benefits of a medication outweigh its risks.

Under the program, the drug may only be prescribed by a certified health provider who must obtain a signed agreement from the patient after counseling and prior to prescribing.

Danco and GenBioPro, which are responsible for implementing the REMS, worked with the FDA for a year on updating the program to add in the new certification requirements. The FDA added the rule when the agency announced in December 2021 that it would permanently lift a previous requirement that patients physically visit a medical provider to receive mifepristone.

Nouhavandi said removing the in-person requirement allows for improved medication abortion access. But HoneyBee is still only able to ship mifepristone to the 24 states that don’t have abortion bans or state laws prohibiting mifepristone via telehealth, she said.

The pharmacy requirements may also be a heavier lift for non-chain companies that don’t have the time or resources necessary to develop systems in line with the FDA regulations.

“We were a bit disappointed that they added another barrier of pharmacy certification, because that does prevent more pharmacies from doing this work, especially smaller, independent pharmacies who we know are being affected greatly right now” during the Covid-19 pandemic, Nouhavandi said.

The American College of Obstetricians and Gynecologists opposes the REMS restrictions on mifepristone, saying that “decades of evidence and the consensus of the medical community underscore” the drug’s safety, according to the professional group’s website. The American Medical Association has also repeatedly called for the FDA to remove the safety requirements.

Danco said in a statement Tuesday that it “has worked to ensure that the REMS modifications will not disrupt the medication abortion services that are currently being provided by existing” providers of its brand-name Mifeprex. The company added, though, that there may be an “adjustment period” as the new changes are implemented.

“At a time when people across the country are struggling to obtain abortion care services this modification is critically important to expanding access to medication abortion services and will provide healthcare providers with an additional method for providing their patients with a safe and effective option for ending early pregnancy,” the company added in a press release.

Testing FDA’s Authority

The updated certification plan comes as the FDA faces a lawsuit testing its authority to regulate mifepristone. The challenge from Christian legal advocacy group Alliance Defending Freedom before a Trump-appointed Texas judge poses the greatest legal threat in years to access to abortion pills in America.

The Biden administration has defended the FDA’s authority in regulating the abortion pill, with Attorney General Merrick Garland noting in a statement following the Supreme Court’s June ruling that “states may not ban Mifepristone based on disagreement with the FDA’s expert judgment about its safety and efficacy.”

The House on Dec. 21 adopted a nonbinding resolution (H.Res. 1434) reaffirming the FDA’s “well-established authority” to “approve, license, grant authorization for, or clear reproductive health products under the Federal Food, Drug, and Cosmetic Act.”

The resolution also says FDA regulations preempt any state or local measures intended to block or limit access to reproductive health products, including mifepristone.

To contact the reporter on this story: Celine Castronuovo at ccastronuovo@bloombergindustry.com

To contact the editors responsible for this story: Alexis Kramer at akramer@bloomberglaw.com; Cheryl Saenz at csaenz@bloombergindustry.com