Pharmacy dispensing of abortion pill has begun, says drug’s generic manufacturer

Pharmacy dispensing of the abortion pill mifepristone (Mifeprex) has begun, according to the drug’s generic manufacturer GenBioPro, which published a list of already approved “certified pharmacies” who agreed to be publicly named, according to Politico.

And, while mail order pharmacies such as Manifest Pharmacy, HoneyBee Health, and American Online Pharmacy (AMOP) have been dispensing the drug for some time, it remains unclear whether chain pharmacies such as Walgreens, CVS, or Rite-Aid have finalized their certification to dispense the drug.

According to Politico:

Fraser Engerman, a spokesperson for Walgreens, told POLITICO the company is “in the last stages of finalizing certification,” while CVS’ Amy Thibault said its officials will “continue to work through the steps” of obtaining certification to dispense the drug. Those steps include securing an adequate supply of the pills, building a system that protects the privacy of patients, and verifying that only certified doctors are sending prescriptions to certified pharmacists.

Politico added that “the large pharmacy chains confirmed they have not been deterred” by the “threat of a future national rollback of the drugs,” including a lawsuit which could limit conditions under which the drug could be dispensed to those that were in place before 2016.

Dispensing History

The abortion pill, mifepristone (200mg), was approved by the Food and Drug Administration (FDA) in 2000 to be used in a regimen with a second drug called misoprostol. In 2011, the FDA made the decision to place the drug under its REMS safety system, but not before multiple women had died in association with use of the abortion pill regimen.

In April of 2021, under the auspices of the COVID-19 pandemic, the Biden Administration FDA temporarily enabled abortion pill distribution and expanded the REMS to allow limited mail-order pharmacy distribution. By December of 2021, the Biden FDA had further weakened the REMS by eliminating the in-person dispensing requirement and enabling the abortion pill to be permanently shipped by mail and ordered virtually, with little to no follow-up.

Those FDA modifications required that “pharmacies that dispense the drug be certified,” and a handful of mail-order pharmacies were allowed to dispense on behalf of prescribers. These included Manifest Pharmacy, HoneyBee Health, and American Online Pharmacy (AMOP).

Then, in January 2023, the FDA further gutted the REMS by announcing it would allow retail pharmacies to dispense the drug. It was at this time that the FDA officially published the certification process for pharmacies.

Who is GenBioPro?

GenBioPro (GBP), located in Las Vegas, Nevada, and headed by its president Evan Masingill, was approved as the generic drug maker by the FDA in 2019. Just as the originally approved and highly secretive abortion pill manufacturer Danco Laboratories was started using investment dollars from the pro-abortion David and Lucile Packard Foundation, so GenBioPro has been funded by this abortion philanthropy group. In addition to Packard, the San Francisco-based Parsemus Foundation has been granting GenBioPro thousands in loan dollars.

“Since 2019, when GenBioPro received approval from FDA to sell generic mifepristone, GenBioPro has marketed and sold more than 850,000 units of the product throughout the United States,” GBP wrote in a recent lawsuit. “Between 2017 and 2020 (the year after GenBioPro began marketing its product), medication abortions in the United States increased by 45 percent, even as the overall number of abortions has declined since the 1990s. Medication abortion now accounts for the majority of pregnancy terminations in the United States.”

Since 2000, the estimated number of women who have used the abortion pill mifepristone in the U.S. for “medical termination of pregnancy through the end of December 2022 is approximately 5.9 million women,” according to a recently published FDA report.

Pharmacy Certification to Dispense the Abortion Pill

“As of January 3, 2023, pharmacies who become certified in the Mifepristone REMS Program may dispense Mifeprex directly to patients upon receipt of a prescription from a certified Mifeprex prescriber, provided a Prescriber Agreement is provided or on file with the certified pharmacy. Pharmacies must designate an authorized representative to carry out the certification process and oversee implementation and compliance with the Mifepristone REMS Program on behalf of the pharmacy,” Danco states on its website.

“Mifepristone is available only under an FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) program. To become a certified pharmacy and fill prescriptions for GenBioPro mifepristone tablets, 200 mg, a pharmacy must be able to meet the requirements of the REMS program. For example, certified pharmacies must receive and retain a completed and signed Prescriber Agreement from any prescriber for whom they fill prescriptions. See detailed REMS requirements,” the GBP website states.

GBP adds that “Heavy bleeding, cramping, and nausea are common side effects of the mifepristone/misoprostol regimen. The following are serious and sometimes fatal complications, requiring immediate medical attention:

• Infection and sepsis: a sustained fever of ≥100.4°F, severe abdominal pain, or pelvic tenderness may be indications of an infection.

• Uterine bleeding: prolonged heavy bleeding (soaking through two thick sanitary pads per hour for 2 consecutive hours) may be a sign of incomplete abortion or other complications.”

GenBioPro Publishes List of Certified Pharmacies

In January of 2023, Danco Laboratories, which oversees the U.S. manufacturing of Mifeprex, had only named American Mail Order Pharmacy (AMOP) and Manifest Pharmacy as the two companies they use to dispense the drugs, while GenBioPro had only named American Mail Order Pharmacy (AMOP) and Honeybee Health as its “currently Certified Pharmacies.”

This week, that changed when GBP published a list of certified pharmacies willing to be publicly named.

“Most of the first pharmacies certified to dispense the drug are in states with legal protections for abortion in general and the pills in particular, including California, Maryland, New York, Pennsylvania and Washington. But some are in states with near-total bans, like Texas, and in states that cut off access early in pregnancy, including South Carolina, which has a six-week prohibition, and Arizona, which has a 15-week ban. The abortion laws in Wisconsin, where one pharmacy is certified to dispense, remain in legal limbo,” reported Politico.

GenBioPro’s (GBP) list of certified pharmacies includes Halowells Pharmacy, reportedly located at 2522 Westminster St. in Pearland, Texas — a state which has laws protecting vulnerable preborn children and allows for civil remedies through a private-enforcement provision of the Texas Heartbeat law.

GBP is dispensing abortion drugs through university and independent hospital pharmacies such as Genesee Campus Apothecary, an “in-house pharmacy” at Unity Specialty Hospital in Rochester, New York, as well as the Madison, Wisconsin-based Meriter Outpatient Pharmacy, located in the lobby of UnityPoint Health Hospital — ironically “home of Wisconsin’s largest birthing center.”

Others include Temple University Hospital Outpatient Pharmacy in Philadelphia, Pennsylvania; University of Maryland Medical Center (UMMC) Pharmacy at Redwood in Baltimore, Maryland; University of Rochester Medical Center (UR) Specialty Pharmacy in Rochester, New York; and USC Medical Plaza Pharmacy at Keck Medical Center located at the University of Southern California (USC) in Los Angeles.

GBP’s list also includes Globe Drug Store in Brooklyn, New York;  Jim’s Pharmacy & Home Health, a locally owned and operated pharmacy in Port Angeles, Washington; and St. Mary’s Pharmacy in Fresno, a member of the Medicine Shoppe family of pharmacy chains. Wellspring Pharmacy, headed by Andrew Beyers and supported by Thao Ho in Oakland, as well as the Fairmont Pharmacy in Phoenix, Arizona, are also on GBP’s list.

Also on GBP’s list is SMP Pharmacy Mid-Atlantic in Rockville, Maryland, which has branches in Florida and California, and claims to “know the ins and outs of the fertility process.” It adds that “Our team of specialists are dedicated to providing every patient with the resources and support they need to start their journey.”

In addition, the generic abortion pill maker appears to be working with pharmacies associated with the Good Neighbor Pharmacy (GNP), a national independent pharmacy network offered through AmerisourceBergen (recently renamed Cencora), one of the largest pharmaceutical distribution companies in the world. AmerisourceBergen also happens to be a large distributor of Mifeprex, according to Vox News. In March 2023, the company wrote in a news release: “We have and will continue to make Mifeprex available to eligible medical providers in all 50 states, and with the January 2023 FDA decision to allow retail pharmacies to dispense Mifeprex, we are distributing to certified retail sites of care in states where it is consistent with the law.”

These pharmacies include Auburn Pharmacy and Compounding in Bakersfield, California, which points to the GNP network from its Facebook page. In addition, Sweetgrass Pharmacy and Compounding in Mt. Pleasant, South Carolina, is also part of the Amerisource Bergen Good Neighbor Pharmacy network, as is Haller’s Pharmacy and Medical Supply (here) — a community pharmacy in Fremont, and Pucci’s Pharmacy in Sacramento, California.

HoneyBee Health, a California based mail-order pharmacy, which once claimed to be the first pharmacy to ship abortion pills for prescribers of the drug, is also listed by GBP. That mail-order pharmacy approval preceded the FDA’s expansion of mifepristone to retail pharmacies — something HoneyBee called “a momentous achievement for Americans.” The pharmacy was founded in 2017 by Peter Wang and Dr. Jessica Nouhavandi, the latter of whom has referred to abortion safety regulations as “archaic.” (Read more here.)

Not yet listed on GBP’s website is the recently-certified Condo Pharmacy in Plattsburgh, New York. Owner Steve Moore told Politico that he hasn’t received any backlash yet, and he is happy to “help people get the medication they need when they need it.”

“Danco, the pharmaceutical company that makes the brand-name version of mifepristone, told POLITICO it has certified many of the same pharmacies as GenBioPro as well as others, but is not making its directory public until it has the pharmacies’ permission,” Politico also wrote.

Previous studies on pharmacy dispensing of the abortion pill have revealed potential problems with whether pharmacists are knowledgable enough to properly advise the women to whom they dispense the drugs. In Nevada, a woman recently claimed that CVS Pharmacy gave her the wrong drugs and then failed to properly counsel her about the pills. She tragically and unknowingly then took the Cytotec (misoprostol — the second drug in the abortion pill regimen), causing the loss of her embryos.

In addition, a 24-year-old mother allegedly died from a ‘septic abortion’ just days after obtaining the abortion pill regimen at Planned Parenthood. A wrongful death lawsuit has been filed in the State of Nevada against Dignity Health Emerus, the hospital system where the mother went for help when she experienced complications.