Following the Supreme Court’s decision to overturn Roe v. Wade, abortion rights activists are calling for the FDA to consider making abortion medication Mifeprex an over-the-counter option for patients.
Following the U.S. Supreme Court’s decision to overturn Roe v. Wade, abortion rights activists are calling for the U.S. Food and Drug Administration to consider making abortion medication Mifeprex an over-the-counter option for patients.
Mifeprex is manufactured by privately-held Danco Laboratories. The Wall Street Journal reported that activists are hopeful the FDA will remove safety restrictions on the drug and also expand its label or without a prescription for use with miscarriage. Mifeprex is used as an off-label drug for miscarriage. If the drug’s label is expanded to include miscarriage, that could make it more difficult to prosecute doctors who prescribe the drug in states where some of the more restrictive anti-abortion laws have been put in place since the landmark legislation was overturned.
For this to happen, the FDA said Danco will have to present data showing that Mifeprex (mifepristone) is safe under these circumstances. However, the Journal reported that Danco does not have any plan in place to seek an expanded label for miscarriage. A company spokesperson told the Journal that it is common for activists to “see us go further and do more than what we’ve done.” The spokesperson said the company makes its decisions in a pragmatic manner to do what it can.
The Journal noted that Danco, which has fewer than 25 employees, does not have the financial resources to conduct additional clinical trials or the legal work necessary to have the FDA make changes to the product label. Mifeprex is the company’s only product.
Mifeprex was approved by the FDA in 2000 and the first generic form of the drug was approved only three years ago. There are other abortive drugs as well, including Corcept Therapeutics’ Korlym (mifepristone) and Pfizer’s Cytotec (misoprostol). As BioSpace reported earlier this year, ahead of the court’s decision to overturn Roe v. Wade, a report said that in more than half of all abortions in the United States, 54% are conducted with the use of a pill, rather than surgery. Medication abortion is typically accomplished with the use of two pills, mifepristone and misoprostol. The drugs are administered up to 70 days or 10 weeks after the first day of the woman’s last menstrual period. Mifepristone blocks the hormone progesterone, which is necessary to support a developing fetus, while misoprostol causes the uterus to empty.
Since the overturn of Roe v. Wade, several states have approved legislation that would severely restrict access to abortion in most cases of pregnancy. Opponents of abortion are pushing state legislatures to restrict access to abortion pills, which are available through the mail, the Journal noted.
Biotech Execs Strongly Denounce Overturning of Roe
Following the Supreme Court’s decision, several female biotech and pharma executives signed an open letter decrying the legal action.
“Abortion is reproductive healthcare. As doctors, scientists, innovators, caregivers, leaders and allies who are at the forefront of innovation in science and medicine for the benefit of patients and women around the world - we decry and denounce the decision by the Court,” the letter said. “It negates the ability of medical practitioners that are best suited to provide care to vulnerable, pregnant women. It flagrantly ignores the physical, mental and financial consequences of carrying an unwanted pregnancy to term.”
The letter further goes on to say that the “right to be pregnant or unpregnant” is a personal choice and civil liberty that should be constitutionally protected.
The letter was signed by 70 female executives including Shehnaaz Suliman, chief executive officer of ReCode Therapeutics; Amy Burroughs, CEO of Cleave Therapeutics; Rene Russo, CEO of Xilio Therapeutics and Grace E. Colon, CEO of InCarda Therapeutics.
“As providers, innovators, caregivers and leaders at the forefront of innovation for patients and women - we believe that our reproductive choices are fundamental human rights that deserve to be upheld,” Suliman wrote on her LinkedIn page.
