JW President Tom Fitton said that the organization was forced to sue after the FDA (which is overseen by the HHS) failed to respond to three FOIA requests from February of 2022.
“Our experience is that this chemical abortion pill did not and will not receive appropriate review from the politicized FDA,” Fitton said in a press release. “It is outrageous that Judicial Watch has had to sue in federal court for basic safety information about the abortion pill, which is being pushed on women by a desperate pro-abortion movement.”
The press release says that the records requested include "drug stability test results, new drug applications and related materials of the abortion drug Mifeprex (Mifepristone, formerly known as RU-486), as well as requests for reviews and assessments of the manufacturing facilities DANCO and GenBio where the abortion pills are produced."
The drug stability information JW requested would verify the shelf life of mifepristone and what happens as the pill degrades during storage. For example, if the pill is stored for hours in a location with temperatures outside the range on the pill's label (59° to 86°F), what effect does the pill have? This question becomes increasingly important as pills are delivered through the mail with loosened FDA regulations. Mailboxes could hold pills for hours at temperatures above or below that range.
“The Biden administration wants the pill to have wide access, so anything that threatens that agenda will be kept secret,” Fitton told Fox News. “If this pill is as important as the Biden administration suggests, then American women have the right to as much information as possible on its safety and efficacy.”
JW's lawsuit is asking the court to recover attorneys' fees and litigation costs. It is also asking the court to require the HHS to produce “any and all nonexempt records” and enjoin the HHS from withholding such records in the future.
