PROCLAMATION

In the case – Alliance for Hippocratic Medicine v. FDA and Danco Laboratories

This is an Appeal to Heaven to affirm Judge Kacsmaryk’s decision of April 6, 2023 from the United States District Court for the Northern District of Texas, Amarillo Division, on appeal in the Fifth Circuit of the United States Court of Appeals.

Specifically, that the 5^th Circuit, and any other court reviewing the case, would affirm the findings and orders of the court that:

• The Alliance for Hippocratic Medicine has standing to bring this case against the FDA (which now includes Danco Laboratories – the manufacturer of mifepristone (a/k/a RU-486 and Mifeprex));

• The FDA approved the drug mifepristone for distribution, with certain protocols, in 2000. The FDA relaxed its own safety protocols for women and girls who would be prescribed the drug, without requiring the risk evaluation and mitigation strategy (REMS);
• The 2000 approval by the FDA was challenged in 2002 by the filing of the Citizen’s Petition.
• The FDA’s March 29, 2016 response to the 2002 challenge denying that challenge and changing provisions of the prescribing and dispensing of the drug protocol granted in 2000 re-set the time to challenge the 2000 determinations. The FDA’s actions relaxing the  minimal protocols in place for the prescribing and dispensing of the drugs was arbitrary, capricious and egregiously wrong.
• The FDA’s failure to timely respond to the Citizen’s Petition filed in 2002 for 14 years was egregious and a dereliction of the agency’s duty to act in the public good. By law, the decision should have been rendered in 180 days from the date of filing.
• The FDA’s April 11, 2019 approval of the generic version of mifepristone, on the faulty foundation of the 2000 approval, and without requiring or reviewing new peer reviewed science, was egregious.
• The FDA’s April 12, 2021 action allowing dispensing of mifepristone through mail or mail-order pharmacy during the COVID pandemic ignored the Comstock Act banning mailing of such drugs.
• The FDA’s December 16, 2021 denial of the 2019 petition challenging the March 29, 2016, relaxing of the drug approval protocol and after approving the generic version of mifepristone and after further relaxing the dispensing of the drug requirements to include mail or mail-order pharmacy distribution, was egregious.
• The FDA’s delayed response to the 2019 Petition challenging the March 29, 2016 change provisions of the 2000 protocol was untimely. The response was required to be rendered 180 days from the date of the challenge. 
• The Pre-2021 FDA decisions are reviewable and are not time-barred, including the original approval in 2000.
• The Comstock Act, which prohibits the distribution of abortion-inducing drugs by mail or common carrier (Fed Ex, UPS, etc) is illegal, should be upheld. It has not been repealed by implication or by Congress.  It is still good law.  The Act may have been dormant during the years Roe v. Wade was the law but, with the reversal of Roe, the Act, that was never repealed or even declared unconstitutional, must be revived and given full effect throughout the nation. 
• Not raising the Comstock Act violation at the administrative agency level does not render the violation time-barred for failing to exhaust the administrative remedy as same would have been a futile exercise, as other facts in the case make evident. In addition, the FDA  comes to this case with unclean hands.  They are in no position to challenge the timeliness of anything.
• There is a substantial threat of irreparable harm to the women and girls prescribed the chemical abortion regimen who are at risk of death or physical and emotional trauma from administering of the drugs, with few to no safety protocols in place. There is also substantial threat of irreparable harm to the doctors who have found themselves stressed in emergency situations caring for women who have severe complications and they are being required to perform surgical abortions in emergency situations, which is an affront to their own consciences.  There is no adequate remedy at law for these harms.  Monetary damages cannot fix these harms. 
  (Ps. 89:14 . . . and Ps. 24:3-4 – clean hands, clean hearts)
• The likelihood of success on the merits is very high as the FDA disregarded its own safety protocols prior to approval of the drug in 2000. The FDA’s approval of the drug – mifepristone – and the chemical abortion regimen – was arbitrary, capricious, unlawful and egregiously wrong.
• Granting the preliminary injunction is in the public interest. Ensuring women and girls are protected from unnecessary harm outweighs the concerns of the FDA and Danco.  The arguments in favor of prescribing and dispensing of the abortion drugs by maintaining the status quo carries vestiges of eugenics and rewards the FDA for participating, unlawfully, in establishing the status quo by ignoring its own time standards and relaxing most or all of the safety protocols even the FDA recommended.  This casting aside the very purposes for which the agency was established to further an agenda and from political pressure have no place in society or current jurisprudence. 
• The District Court’s Stay of the effective date of FDA’s September 28, 2000 approval of mifepristone and all subsequent challenged actions related to that approval – the 2016 changes, the 2019 Generic Approval and the 2021 actions (allowing mail-order distribution) is affirmed.