On Monday, the pharmaceutical industry dove headfirst into the ongoing legal battle over the abortion pill mifepristone, delivering a scathing denunciation of a federal judge’s verdict that invalidated the Food and medicine Administration’s clearance of the medicine and demanding that the FDA’s decision be overturned.
On the same day, the Department of Justice appealed the judgement of U.S. District Judge Matthew J. Kacsmaryk from the Northern District of Texas to the United States Court of Appeals for the Fifth Circuit. In order to give the government time to file an appeal, Judge Kacsmaryk, a Trump appointee who has written negatively of Roe v. Wade, ordered a stay of his judgement for just seven days.
A related litigation involving mifepristone has also had a motion filed by the Justice Department. A contrary judgement was made less than an hour after the Texas verdict, which was released on Friday evening, in a lawsuit brought in Washington State against the F.D.A. by 18 Democratic attorneys general who challenged further limits that the agency puts on the medicine.
The executives from biotech and pharmaceutical companies signed a statement expressing concern about the destabilising effects of the Texas verdict.
ReCode Therapeutics CEO Dr. Shehnaaz Suliman testified that she and former Blackfynn Therapeutics CEO Dr. Amanda Banks started composing the letter a few weeks ago, following a hearing in the matter before Judge Kacsmaryk in Amarillo, Texas on March 15.
After the verdict was handed down on Friday night, Drs. Suliman and Banks met electronically with Drs. Levin and three other executives to fine-tune their draught. Dr. Banks and others “pulled an all-nighter” to finish the project on time, Dr. Levin added.
Dr. Levin said the organisation forwarded the draught to about a hundred business leaders, many of whom signed and then distributed it to their staff and other industry executives. “In our experience, people don’t decline — they just don’t respond,” he said when asked whether anybody had refused to sign.
Few of the signatories work in the field of reproductive health. Misoprostol, the second medicine in the pharmaceutical abortion regimen, is licenced for various medical ailments but is used off-label for abortion; one signatory, Pfizer, produces a minor fraction of the U.S. supply.
According to experts in the field, the Texas verdict seems to be the first time a court has attempted to overturn the F.D.A.’s approval of a medicine. The agency’s power to evaluate medication quality and safety has been vested in it by Congress for many years.