{"id":291432,"date":"2023-06-08T16:39:44","date_gmt":"2023-06-08T21:39:44","guid":{"rendered":"https:\/\/www.liveaction.org\/news\/?p=291432"},"modified":"2023-06-08T11:59:01","modified_gmt":"2023-06-08T16:59:01","slug":"judge-fda-delay-documents-abortion-pill","status":"publish","type":"post","link":"https:\/\/archive.liveaction.org\/news\/judge-fda-delay-documents-abortion-pill\/","title":{"rendered":"Judge appears frustrated at FDA’s delay in producing abortion pill documents"},"content":{"rendered":"
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During oral arguments in the case<\/a>\u00a0Alliance for Hippocratic Medicine (AHM) v. Food and Drug Administration <\/em>(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<\/a>, studies, trials<\/a> or data surrounding the often<\/a> secretive<\/a> abortion pill approval<\/a> process.<\/p>\n

“In Administrative Procedure Act lawsuits, the government is obligated to produce the ‘administrative record’\u2014essentially, 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.”<\/p>\n

Where is the Official Administrative Record?<\/h3>\n

The\u00a0AHM lawsuit<\/a>\u00a0centers on\u00a0a\u00a0ruling<\/a>\u00a0by U.S. District Court Judge Matthew J. Kacsmaryk which\u00a0suspended<\/a>\u00a0the FDA\u2019s 2000 approval of the abortion pill mifepristone, and all decisions made thereafter. The case was appealed<\/a> but a temporary stay<\/a> was then issued<\/a> by the Supreme Court until a decision could be rendered by the Appeals Court.<\/p>\n

Oral arguments in AHM v. FDA were presented<\/a> last month before a panel of judges<\/a> 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<\/strong> to gather the documents \u2014\u00a0at which point Judge Jennifer Walker Elrod, one of the three judges hearing the case, became annoyed.<\/p>\n

“I just wanted to ask quickly about the record,” Judge Jennifer Walker Elrod said<\/a>. “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.<\/p>\n

“We absolutely do not have the administrative record,” the FDA’s attorney confirmed to Judge Elrod.<\/p>\n

“Why don’t we?” the judge asked.<\/p>\n

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.”<\/p>\n

“Where is it and how do we get it?” Judge Elrod asked.<\/p>\n

“The District Court acted before we were able to produce,” Harrington claimed.<\/p>\n

“How long will it take you to get it to us?” Judge Elrod asked.<\/p>\n

Harrington was unable to give the judge a precise date, which seemed to frustrate the judge.<\/p>\n

“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.<\/p>\n

“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.<\/p>\n

But Harrington had no date. “FDA is working hard on it, and I don’t have an estimate for when it’s gonna happen.”<\/p>\n

“Do you know when you started working on it?” Elrod asked.<\/p>\n

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.”<\/p>\n

“So how soon can we get the record?” Judge Elrod asked again, reiterating that it\u00a0“seems like something we would want to know about.”<\/p>\n

“I can go back and talk to my clients. I don’t think its going to be imminent,” Harrington said in response.<\/p>\n

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?”<\/p>\n

“It’s not a secret, it’s like in cold storage somewhere,” the FDA’s attorney said in response.<\/p>\n

“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.<\/p>\n

“I know it’s frustrating,” Harrington said, “I don’t have anything more specific to tell you,” Harrington said in response.<\/p>\n