Ironic twist: Abortion industry wants transparency regarding abortion pill review
The pro-abortion Center for Reproductive Rights (CFRR) has filed a lawsuit over what it claims is the Trump Administration's "failure to respond to multiple Freedom of Information Act [FOIA] requests seeking transparency around its re-evaluation of abortion pill safety."
CFRR's lawsuit, filed against the Food and Drug Administration (FDA) as well as the Department of Health and Human Services (HHS), seeks to "compel compliance with the requirements of FOIA."
The irony that abortion advocates would seek "transparency" is glaring, given the decades-long secrecy behind the original approval process of the abortion pill (mifepristone 200mg).
The Backstory:
The FDA initially approved mifepristone under the Clinton administration in 2000 for use in chemical abortions up to seven (7) weeks of pregnancy in a regimen along with a second drug called misoprostol. As the years went on, the use of the drug was expanded multiple times — enabling the drug to be prescribed up to 10 weeks/70 days gestation, removing the in-person requirement for dispensing the pill, and, more recently, allowing for mail-order and pharmacy dispensing of the drug.
Today, bad actors inside the abortion industry openly flout these FDA regulations.
Accordingly, the Center’s July 18 FOIA request to the FDA seeks information to better understand the FDA’s decision to review mifepristone, the process the FDA plans to use to conduct this review, and whether the FDA will be considering data from EPPC and/or other third parties during such review...
[T]he Center’s FOIA request to HHS seeks information on whether the FDA will be considering data from EPPC and/or other third parties during the review, and what influence HHS leadership and staff may exert over the FDA’s review of mifepristone and decision making...
It claimed, "When an agency has 'improperly withheld' records, this Court may “enjoin the agency from withholding agency records” and “order the[ir] production."
Demand For Records
"Recently, FDA Commissioner Marty Makary gave an interview where he announced that he has no plans to change the FDA policy around mifepristone; however, he caveated this pronouncement by noting 'an ongoing set of data that is coming into the FDA on mifepristone' could present new evidence requiring the FDA to take new action," CFRR claimed in its MayFOIA Request to the FDA, reiterating it in July.
Makary's statements followed the publication of an analysis of insurance data research conducted by the Ethics & Public Policy Center (EPPC), which purported to show that 1 in 10 women who take abortion pills suffer serious adverse events such as ER visits, surgeries, or dangerous infections.
As a result, CFRR demanded:
"All communications, meeting notices, meeting agendas, informational materials, draft legislation, draft rules, talking points, reports, disclosures, or other documents sent to, received by, or exchanged with any FDA employee (temporary or permanent), official, appointee, or contractor and any employee of EPPC."
CFRR added a list of named individuals and demanded access to "documents sent to, received by, or exchanged with any FDA employee (temporary or permanent), official, appointee, or contractor and Senator Josh Hawley or any employee within the Senator’s office."
In early September, HHS Secretary Robert Kennedy, Jr. (RFK), indicated again that the abortion drug is under review by the FDA Commissioner, suggesting that the Biden Administration "twisted the data" on the abortion pill.
Live Action News has documented that for decades, the abortion industry has participated in a scheme to hide abortion pill complications by advising women to bypass the prescriber’s office (who is obligated under the drug’s FDA REMS requirements to report complications to the manufacturer) and present directly to an emergency room, having been instructed to falsely claim that they are experiencing a natural miscarriage. This deception virtually guarantees that such complications will never be reported — but CFRR doesn't appear concerned about that.
Danco was seeded with funding from abortion philanthropy groups, including the David and Lucile Packard Foundation, which invested well over $14.2 million in the manufacturer and has funded studies claiming the drug is safe. The Packard Foundation has also been investing millions in the generic pill manufacturer, GenBioPro.
Former FDA agency leaders have kept secret the names of “experts” who reviewed the abortion pill for approval, while accepting clinical trials and published reports by known abortion insiders — some tied to the pill’s investors.
The pill’s 11-year journey to the United States included a cloak-and-dagger scheme to hide the identities of participants from anti-abortion activists, allegations of fraud, a dozen lawsuits, and a price tag of at least $50 million.
In a strange twist, the FDA acceded to Danco’s request that the name of its manufacturer be kept secret — and even shielded the names of the FDA researchers who had overseen the pill’s approval.
The Washington Post pointed out how “FDA Commissioner Jane E. Henney said the agency broke with precedent by not publishing the names of the experts who reviewed RU-486 for the agency. In another first, it did not publish the name or location of the company that will manufacture the drug.”
Fast forward to 2020, when in an interview with early abortion pill advocates, Columbia University journalists located one of the FDA’s senior medical reviewers who “chose to remain anonymous” but admitted, “It’s definitely not standard. It’s not routine; you can look up almost every other drug that I was the primary medical officer for and my name would appear right there on the review.”
“And we did,” noted one of the journalists. “His name is listed on at least eight other FDA drug reviews. But no staff names are listed on the review of mifepristone.”
An Elusive Historical Record
The Center for Reproductive Rights failed to mention the historical ‘record’ relating to the abortion pill's approval process, which, as Live Action News previously documented, has been cloaked in secrecy as well, leading some to inquire whether ‘experts’ who rubber stamped the drug may have been associated with pro-abortion organizations or were abortionists themselves.
Was the data properly analyzed, or did bias in favor of abortion take precedence over actual safety?
During oral arguments in the caseAlliance for Hippocratic Medicine (AHM) v. Food and Drug Administration, a tense exchange took place between the FDA’s legal representative and a judge on the U.S. Court of Appeals for the Fifth Circuit regarding the apparent “secrecy” surrounding relevant documentation about the FDA’s original approval of the abortion pill.
In that case, the FDA claimed it had not yet assembled the documents, suggesting it was due in part to the fact that there were “hundreds of thousands of pages.” Yet, CFRR doesn't seem concerned that these documents — which may include correspondence, expert reviews, studies, trials or data surrounding the oftensecretive abortion pill approval process — have yet to be gathered.
The Bottom Line:
Until the full record on this approval process is revealed, the American public should continue to question the purported safety of self-managed abortion for women; we already know it has been unsafe for six million preborn children and counting who have died because of it.
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Abortion Pill·By Carole Novielli
