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See No Evil, Hear No Evil, Report No Data on Evil: How Our New FDA Chief Helped Hide Abortion Pill Dangers



How often have the pro-life movement and Senator Bernie Sanders been united on an issue?  It happened last month when President Biden's nomination of Dr. Robert Califf to become commissioner of the Food and Drug Administration (FDA) sparked something exceedingly rare in modern Washington: bipartisan opposition. 

The roots of conservative and liberal opposition to Califf, who is a respected cardiologist, professor of medicine, and expert in clinical research at Duke University, had common outlines but different objects. Senators like Sanders (D-Vt.), Maggie Hassan (D-Vt.), and Edward Markey (D-Ma.) registered opposition over Califf's role in FDA opioid regulation and, at least in Sanders' case, his ties to what some call "the revolving door" between the FDA and the drug industry. For right to life advocates, it was Califf's role in the unscientific, near-eradication of reporting requirements for abortion pill complications during the Obama administration, where he served as FDA commissioner from February 2016 to January 2017.

To fully understand that role, it's important to know the FDA's checkered – which is to say, not evidence-driven – history with the abortion regimen of mifepristone and misoprostol.  FDA approval in late 2000 came with significant safeguards for women's health.  But over the next two decades, the FDA, an agency with a notoriously closed process for evaluating drugs and devices, proceeded (some would argue "receded") from robust patient safeguards to what has become a brisk, mail-order trade with little or no medical support for women and girls consuming these dangerous abortion drugs.

In December 2021, just before Califf's confirmation hearing, the FDA stripped away the better part of the remaining REMS – risk evaluation and mitigation strategies – for abortion pills. Califf had helped pave the way for erosion of safety standards (the abortion pill is never safe for the unborn life it kills) in 2016 when he led the FDA's decision to end the REMS requirement for any health harms short of death to be reported to the agency. Hemorrhage, need for follow-up surgical abortion, infection, ectopic pregnancy, near-death experience? No need to tell the FDA. 

Conveniently, this non-reporting regime now allows the FDA and abortion industry to claim the abortion pill poses no serious risks. See no evil, hear no evil, report no data on evil.

Yet robust Medicaid data from 17 states which publicly fund elective abortion, ignored by the FDA but analyzed by respected public health scientists, show the real-world impact. The rate of abortion pill-related emergency room visits increased more than 500 percent from 2000 through 2015.

On top of laying the asphalt for mail-order abortion, the FDA's treatment of mifepristone had other unique features. The manufacturers of the drug – Danco Laboratories and the generic-maker GenBioPro – make no other drugs. The abortion pill is all they have. This makes the companies invulnerable even to collateral pressure that they act responsibly with the FDA because they will have future products come before the agency.

During his confirmation hearing, Dr. Califf was asked for his thoughts about the FDA's review process for abortion pills. In the converse of the underling who says he was only following orders, Califf testified multiple times that he trusted the FDA staff would do the right thing. Of course, the right thing, in this case, proved to be a star-chamber proceeding that would allow him to duck responsibility.

Should the American people trust the FDA? There are many on both sides of the aisle – including liberals who are alarmed about the spread of death-dealing opioids – who answer in the negative. The FDA receives significant funds from the industry it is charged with regulating. It bears little or no responsibility to share with the public what research it has reviewed, which experts have reviewed that research, and how the drugs it approves will be monitored. The REMS for mifepristone was inherently weak; it is now completely toothless.

Despite bipartisan opposition and the rare alignment of pro-life and far-left senators, Dr. Califf was narrowly confirmed by the Senate.  Yet two issues that American Christians care deeply about … abortion drugs and opioid abuse … slowed the nomination considerably and forced both Washington and the mainstream media to give attention to the FDA's role in expanding access to these dangerous drugs. 

The confirmation process is weighted in favor of those currently in power. Moreover, both industry and regulatory bodies need special expertise. But the confirmation process can at least compel an open forum where the public can see the insiders and lobbyists, the ideologues and the exploiters, who manipulate and profit from government decisions. Whether your issue is the toll of addiction or abortion, the public interest demands nothing less.

Charles A. "Chuck" Donovan is president of Charlotte Lozier Institute.

Have you have had an abortion, are contemplating ending your pregnancy, or would like pregnancy-related resources, please click here.

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