Abortion Pill

Pro-life coalition urges senators to oppose Califf for FDA commissioner


UPDATE, 1/13/22: By a vote of 13-8, the US Senate Committee on Health, Education, Labor, and Pensions approved the nomination of Dr. Robert Califf as next Commissioner of the U.S. Food and Drug Administration, despite his history of expanding abortion while serving as Commissioner under President Obama in 2016.

1/12/22: A coalition of nearly 50 pro-life organizations, including Live Action, has sent a letter urging U.S. senators to oppose the nomination of pro-abortion Dr. Robert Califf as commissioner for the U.S. Food and Drug Administration (FDA). The vote on whether or not to approve Califf is scheduled for Thursday. However, in an unusual move, the committee has decided not to televise the meeting, and Senator Mike Braun (R-Ind.) has issued a letter calling for transparency and asking Committee Chair Patty Murray (D-Wash.) to allow the meeting to be televised once again.

The pro-life coalition letter, spearheaded by the Susan B. Anthony List, states that the organizations have “profound concerns” surrounding Califf’s nomination. He had previously held the position of Commissioner of the FDA under President Obama — and under Califf’s leadership, abortion was expanded.

“Under Califf’s leadership during the Obama Administration, the FDA significantly undermined the reporting and safety requirements on medication abortion, also known as chemical abortion,” the letter states. “As the abortion industry continues to push for abortion on demand, the FDA needs a leader who will follow the science and prioritize the health and well-being of women and girls. Based on his past (successful) effort to weaken data and safety requirements for chemical abortion, we must oppose his nomination.”

Under Obama, Califf expanded abortion pill access and weakened safety protocols

While serving as FDA Commissioner under Obama in 2016, Califf expanded access to the deadly abortion pill regimen by allowing several modifications to the long-established Risk Evaluation and Mitigation System (REMS) safety requirement. Those modifications included changing the doses of both Mifeprex and misoprostol as well as the method of administration of misoprostol, altering the interval of time between when a woman takes Mifeprex (the first drug in the abortion pill regimen) and misoprostol (the second drug), and extending the gestational age for abortion pill use to 10 weeks.

He also presided over changes to the safety rule that required Mifeprex to be taken at an approved medical location, allowing women and teen girls to take the drug unsupervised at home or a location of their choosing.

READ: Biden’s nominee for FDA Commissioner expanded access to abortion pill under Obama administration

At the same time, the FDA decided it would no longer mandate that Danco, the abortion pill’s manufacturer, report non-fatal complications associated with the abortion pill. Therefore, while loosening safety rules on the use of the drug regimen, Califf also decided that side effects — even those associated with the changes he implemented — would not be reported, hiding the truth of abortion pill complications from the women and girls who may seek out the abortion pill believing it to be safe.

The letter continues:

An exhaustive report published earlier this year on the FDA’s data on deaths and severe adverse events found incomplete data including over 500 ‘uncodable’ events, where women were ‘lost to follow-up’ and there were huge gaps in critical medical information. Still, the existing data within the FDA adverse events reporting (AER) shows evidence of at least 20 deaths, nearly 600 life-threatening events, and over 2,000 severe events, including emergency hysterectomies and ruptured ectopic pregnancies.

Another peer-reviewed study of Medicaid claims data has also found that more than 60% of chemical abortion-related emergency room visits were miscoded as miscarriages. Any claims of safety from the FDA without addressing these serious flaws in available data cannot be taken seriously.

Califf says he would rely on “best available data,” but under Obama, he weakened the collection of data

When asked about the abortion pill during his confirmation hearing before the Senate Health, Education, Labor and Pensions Committee last month, Califf did not address his role in the weakening of safety rules, stating that any decisions made by the FDA would be based on the best available data. However, the data he references is severely lacking due to his own previous changes to abortion pill complication reporting, and the FDA recently decided to further weaken safety regulations surrounding the abortion pill by allowing the dangerous drug — which a study has shown to be four times more dangerous than first-trimester surgical abortion  to be administered via a no-test protocol and mailed to women.

“With a track record of rubber-stamping abortion industry demands and with permanent authorization of unsafe mail-order abortion hanging in the balance,” the letter states, “Califf is the wrong choice for FDA Commissioner. We urge you to vote no on his nomination.”

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