During oral arguments in the case Alliance for Hippocratic Medicine (AHM) v. Food and Drug Administration (FDA), a tense exchange took place between the FDA’s legal representative and a judge on the United States Court of Appeals for the Fifth Circuit regarding the apparent “secrecy” surrounding relevant documentation about the FDA’s original approval of the abortion pill. The missing documents could likely include correspondence, expert reviews, studies, trials or data surrounding the often secretive abortion pill approval process.
“In Administrative Procedure Act lawsuits, the government is obligated to produce the ‘administrative record’—essentially, any document on which the FDA considered and relied on when making its decision,” Erik Baptist, Senior Counsel at Alliance Defending Freedom (ADF), which is representing the plaintiffs in the case, told Live Action News. “FDA has stated that it would take a significant amount of time to retrieve these documents from government storage, carefully review each page for confidential and privileged information, and then produce the record to the court and parties.”
Where is the Official Administrative Record?
The AHM lawsuit centers on a ruling by U.S. District Court Judge Matthew J. Kacsmaryk which suspended the FDA’s 2000 approval of the abortion pill mifepristone, and all decisions made thereafter. The case was appealed but a temporary stay was then issued by the Supreme Court until a decision could be rendered by the Appeals Court.
Oral arguments in AHM v. FDA were presented last month before a panel of judges at the Fifth Circuit. The dialogue became combative when Deputy Assistant Attorney General Sarah Harrington, the FDA’s legal counsel, was asked why the government agency failed to produce the required documents for the court. Harrington relayed to the court that her client (the FDA) had not even started to gather the documents — at which point Judge Jennifer Walker Elrod, one of the three judges hearing the case, became annoyed.
“I just wanted to ask quickly about the record,” Judge Jennifer Walker Elrod said. “We don’t seem to have the administrative record in this case,” she added, acknowledging she had “checked with the clerk’s office” that morning.
“We absolutely do not have the administrative record,” the FDA’s attorney confirmed to Judge Elrod.
“Why don’t we?” the judge asked.
Admitting that the court “absolutely need[s] it,” Harrington sounded rattled as she admitted that the FDA had not yet assembled the documents, claiming it was due in part to the fact that there were “hundreds of thousands of pages.”
“Where is it and how do we get it?” Judge Elrod asked.
“The District Court acted before we were able to produce,” Harrington claimed.
“How long will it take you to get it to us?” Judge Elrod asked.
Harrington was unable to give the judge a precise date, which seemed to frustrate the judge.
“I can’t give you an estimated time. What we’re told is its going to be hundreds of thousands of pages because the plaintiffs are challenging actions that took place almost a quarter century ago,” FDA’s legal counsel claimed.
“So, you’ve been working on it this whole time since the inception of the District Court matter? Or when did you start working on it?” Judge Elrod asked.
But Harrington had no date. “FDA is working hard on it, and I don’t have an estimate for when it’s gonna happen.”
“Do you know when you started working on it?” Elrod asked.
Frustrated, Harrington told the judge, “I don’t know… I don’t have a date I can give you. I think they started working on it as soon as the case got going,” Harrington said almost as a guess. “I cannot give you an exact date.”
“So how soon can we get the record?” Judge Elrod asked again, reiterating that it “seems like something we would want to know about.”
“I can go back and talk to my clients. I don’t think its going to be imminent,” Harrington said in response.
Judge Elrod then asked in an an annoyed tone, “Can you produce it in stages if you can’t produce it all at once? Is it a secret? I mean it’s the record, right?”
“It’s not a secret, it’s like in cold storage somewhere,” the FDA’s attorney said in response.
“But – I mean you’ve probably have brought it out of storage by now because you have a big national case on it,” Judge Elrod said.
“I know it’s frustrating,” Harrington said, “I don’t have anything more specific to tell you,” Harrington said in response.
In response, Erik Baptist claimed the FDA was “stonewalling” and called on the court to render a decision on behalf of his plaintiffs with or without the administrative documents. “Plaintiffs have provided the courts with the decision documents on which FDA approved mifepristone and subsequently removed basic safeguards.”
Baptist pointed out to Live Action News, “Throughout this litigation, FDA has never identified a single document missing from this case that could alter the courts’ analysis. The simple truth is that the courts have what they need to decide this case on the merits, and FDA’s continued stonewalling is just another delay tactic to avoid accountability for its actions.”
BACKGROUND
In 1993, pro-abortion President Bill Clinton signed an executive order directing the FDA to expedite the marketing of the abortion pill, RU-486. In 1994, his administration pressured the French pharmaceutical manufacturer Roussel-Uclaf, a subsidiary of Germany’s Hoechst AG, to assign the U.S. rights of marketing and distribution to the Population Council. This eugenics-founded “non-profit” brought the abortion pill into the U.S. and later set up the pill’s manufacturer, Danco Laboratories, LLC, a sub-licensee of the Population Council. It was approved for sale in the United States in September of 2000, with specific restrictions that it not be shipped directly to women but be administered by certified prescribers at a clinic or hospital where follow-up care would be available.
In the years leading up to the abortion pill’s FDA approval, multiple media outlets picked up on what they saw as secrecy surrounding Danco as well as the approval process. Initially, the pill’s manufacturer Danco itself was kept secret, and according to a 2000 Washington Post article, the FDA “took the unprecedented step of refusing to disclose the name or location of the manufacturer.” In a separate article, the Washington Post wrote, “Secretive and obscure, Danco is one of the most enigmatic companies in the pharmaceutical industry… They say Danco intends to make a profit eventually.”
In addition to Danco, media outlets alleged that the FDA 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.
“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,” reported the Orlando Sentinel. “Even FDA spokespeople — the public relations specialists who field reporters’ calls to the agency — are keeping their names confidential as a condition of being interviewed about the drug.”
The Washington Post also pointed out how the FDA “broke with precedent by not publishing the names of the experts who reviewed RU-486 [a.k.a. the abortion pill] for the agency.” In 2000, the Washington Post wrote in another article that “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, where 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.”
