Major US abortion pill producer says it has ample supply if demand soars
Written by Anne Flaherty ABC News on June 24, 2022
(NEW YORK) — Editor’s note: This story was published before Friday’s Supreme Court decision on Roe v. Wade.
A major producer of the abortion pill in the U.S. says it has ample supply if demand suddenly soars in the wake of a Supreme Court decision and that it’s working with federal regulators to make the drug available in pharmacies by the end of the year.
“We are prepared for any surge,” said the spokesperson for Danco Laboratories, which manufactures the brand-name drug Mifeprex.”Our supply is stable and plentiful.”
Mifeprex, along with its generic version, is quickly taking center stage in the abortion debate, as several states move to outlaw its use while others try to expand access.
Here’s what to know about the abortion bill:
What is Mifeprex?
A single 200-mg tablet, Mifeprex is the brand name for the drug mifepristone that is used to end a pregnancy up to 10 weeks. Packed in a blister foil pack inside an orange box, the single tablet induces an abortion by blocking the hormone progesterone.
The pill is typically taken with misoprostol, which causes cramping and bleeding to empty the uterus.
Medical experts say a doctor would not necessarily be able to tell if the woman took the drug or if she miscarried unless she told them.
Mifeprex has been on the market for 22 years, and the FDA regards it as a safe drug for most women. While the number of abortions has declined in recent decades, use of the drug has steadily increased. Now, about half of abortions in the U.S. are medication abortions, rather than a surgical abortion.
While opponents refer to mifepristone as a “chemical abortion,” doctors and drugmakers say that is not a term they use.
How do women get it?
To obtain the drug legally, a woman has to get a prescription from a certified provider.
It’s currently not available through U.S. pharmacies, although Danco Laboratories says it’s working with the Food and Drug Administration so that pharmacies would be allowed to carry the drug by year’s end.
The FDA allows the drug to be prescribed through a telehealth appointment and mailed to her home. However, at least 19 states have enacted laws requiring that the clinician be present physically when administering the drug.
The average cost for women is about $400-$500, a price that includes the consultation with a doctor and follow-up care. But the pill itself only costs about $50. It has a five-year shelf life before it expires.
Who makes it?
For nearly two decades, Danco Laboratories (pronounced DANK-oh) operated as the nation’s sole legal provider of abortion pills in the US, distributing its Mifeprex to all 50 states and territories.
In 2019, a generic version of the drug manufactured by a company called GenBioPro was approved by the FDA.
A third company, Corcept Therapeutics, uses mifepristone to produce an FDA-approved drug for patients with Cushing’s Syndrome. But that drug, called Korlym, which uses a much higher dose of the drug, is not prescribed for abortions.
Both Danco and GenBioPro withhold general information about their companies from the public, including the names of officials, where its facilities are located or production estimates. A spokesperson for GenBioPro could not be reached, while Danco said they do so for security reasons and to protect the privacy of their team members, as well as to safeguard proprietary information.
The FDA said it does not divulge this information either, citing laws aimed at protecting trade secrets and a concern for potential attacks on employees.
“The FDA concluded that there is a risk that individuals associated with the development, marketing and distribution of mifepristone for medical termination of early pregnancy may become the targets of threats of harm or violence,” the agency told ABC News in a statement. “Therefore, the agency does not disclose the names or locations of such individuals.”
Danco will only disclose that the company’s headquarters is located in New York City, while the drug itself is produced out of facilities in Europe that are inspected by U.S. federal officials.
The spokesperson described the company as modestly profitable and said it no longer needs to rely on private investors as it had early on in its tenure.
What happens if Roe v. Wade is overturned?
The Guttmacher Institute, which supports abortion rights, predicts that there are 26 states certain or likely to quickly ban abortion — including medication abortion — “to the fullest extent allowed” by the Supreme Court.
Abortion foes say their goal will be to ensure the drug doesn’t cross state lines.
Still, it’s not entirely clear how easy it will be for states to block a drug that can be obtained through a telehealth appointment and discretely mailed to someone’s home, including from online-based international organizations.
European-based Aid Access, for example, says it relies on a pharmacy in India to mail mifepristone to women in the US without approval by the FDA, despite warnings by the FDA that unregulated drugs can put women’s health at risk.
The result is an untested, complicated legal landscape.
“If there’s a telehealth abortion, that doctor could be in California. That doctor could be in the Netherlands. And in both of those cases, you’re going to have a very hard time getting that doctor into your courtroom,” said Mary Ziegler, a professor at Florida State University College of Law who specializes in the legal history of reproduction and abortion.
ABC News’ Devin Dwyer contributed to this report.
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