New FDA head criticized for role in expanding availability of abortion pill

WASHINGTON (CNS) -- Pro-life leaders criticized the U.S. Senate's Feb. 15 confirmation of Dr. Robert Califf as President Joe Biden's commissioner of the Food and Drug Administration, taking issue with Califf's role in the agency expanding the availability of the drug protocol used for chemical abortions.

The FDA head, a cardiologist who also was the agency's commissioner in 2016 and 2017, faced other criticism over his handling of the nation's opioid crisis and his ties to the pharmaceutical industry.

"Despite the research and science which includes thousands of documented adverse events caused by chemical abortion drugs, Dr. Califf has acted to advance a pro-abortion political agenda," said Jeanne Mancini, president of the March for Life Education and Defense Fund.

"Under his leadership in 2016, the FDA recklessly loosened reporting requirements associated with these dangerous drugs at a time when increasing health and safety oversight was needed. Women deserve better than an FDA that prioritizes politics over their health and safety," she said in a Feb. 15 statement.

New rules announced by the FDA March 30, 2016, effectively expanded how pregnant women can use RU-486, a drug that induces abortion, allow them to use it later into pregnancy and make fewer visits to a doctor.

A chemical abortion involves using RU-486 -- known generically as mifepristone and by its brand name Mifeprex -- in combination with another drug called misoprostol, a prostaglandin.

Mifepristone is taken first to block the body's progesterone and stop the pregnancy from advancing. Then a day or two later, this is followed by misoprostol, which causes cramping and bleeding to empty the uterus.

Expulsion of the dead fetus usually occurs at home, outside any clinical setting.

In July 2020, about two months into the pandemic, U.S. District Judge Theodore Chuang in Maryland agreed to suspend a rule that required women to visit a hospital, clinic or medical office to obtain the abortion pill.

He concluded that such "in-person requirements" imposed a "substantial obstacle" to women seeking an abortion and were likely unconstitutional under the circumstances of the COVID-19 pandemic.

The American College of Obstetricians and Gynecologists and other groups had sued the FDA and the U.S. Department of Health and Human Services in May 2020 to challenge the in-person dispensing rule arguing it infringed on a woman's lawful right to obtain an abortion.

In his ruling, Chuang said suspending the requirements aligned with public health guidance to eliminate unnecessary travel and in-person contact during the pandemic.

The Trump administration appealed the ruling and on Jan. 12, 2021, the U.S. Supreme Court reinstated the federal requirement that women who are seeking abortion-inducing drugs must do so in person, not by mail.

On April 12, 2021, the FDA's acting commissioner, Dr. Janet Woodcock, suspended enforcement of the agency's in-person prescribing requirement for the abortion drug, which pro-life leaders said endangered women's health and possibly their lives.

Woodcock said the FDA would "exercise enforcement discretion" regarding its own requirement that is part of the risk management program for mifepristone as long as Biden's declaration of a public health emergency for COVID-19 remained in place.

Marjorie Dannenfelser, president of the Susan B. Anthony List, said Califf's confirmation "paves the way for permanent authorization of mail-order abortion drugs, at a dire cost to women's health and safety and the lives of countless unborn children."

"We urge our allies in the states and Congress to take swift action to stop the flow of these dangerous drugs to post offices and pharmacies across America," she said in a Feb. 15 statement. "SBA List will continue to monitor the FDA's actions to expand chemical abortion drugs and expose the extremism of the abortion lobby and the pro-abortion Biden administration."

"We will never stop fighting to ensure that unborn children and their mothers are protected under the law," she said.

The vote to confirm Califf was 50-46. Among those who opposed his nomination were Sens. Joe Manchin, D-W.Va., and Maggie Hassan, D-N.H., who said that under his earlier leadership, the FDA mishandled the opioid crisis. From 2016 to 2017, they noted, overdose deaths from all opioids increased 12% to more than 47,000.

Regarding his ties to the pharmaceutical industry, the Bloomberg Law news site reported last November when Biden nominated him that Califf "was paid $2.7 million by Verily Life Sciences, the biomedical research organization operated by Alphabet Inc., and sits on the boards of two pharmaceutical companies, AmyriAD and Centessa Pharmaceuticals PLC."

"He also reported ties to 16 other research organizations and biotech companies," the site added, citing ethics and financial disclosure documents.

Before the Senate vote on his nomination, Califf said that if he were confirmed, he would resign from board positions with Verily, Centessa and Cytokinetics and divest his pharmaceutical stock holdings within 90 days.