Pfizer, hundreds of US drugmakers call for reversal of Texas abortion pill ruling (updated)

Ryder System

10/04/2023 17:19

(Adds details from letter)
    By Michael Erman and Ahmed Aboulenein
       April 10 (Reuters) - Over 300 biotech and pharmaceutical
industry executives, including Pfizer Inc  PFE.N  CEO Albert
Bourla, signed an open letter on Monday calling for reversal of
a federal judge's decision to suspend sales of the abortion pill
mifepristone.
    A U.S. judge on Friday suspended the U.S. Food and Drug
Administration's two-decade-old approval of the drug,
effectively banning sales while a case brought by anti-abortion
groups before him continues in the Northern District of Texas.
    Last week's ruling by Judge Matthew Kacsmaryk undermines the
FDA's authority, the letter's authors wrote, adding that it
ignores decades of scientific evidence and legal precedent.
    "We call for the reversal of this decision to disregard
science, and the appropriate restitution of the mandate for the
safety and efficacy of medicines for all with the FDA, the
agency entrusted to do so in the first place," they wrote.
    Bourla was the first leader of a major pharmaceutical
company to add his name to the letter, which also bore the
signatures of more than 300 executives from smaller U.S.
biotechnology companies.
    The letter was written by ReCode Therapeutics CEO Shehnaaz
Suliman, Blackfynn co-founder Amanda Banks, and Ovid
Therapeutics  OVID.O  CEO Jeremy Levin, who is also a former
chairman of biotech industry lobbying group BIO. 
    The decision puts the entire industry at risk, the letter
says, and sets a precedent for undermining the agency's
authority to approve drugs, adding regulatory uncertainty that 
they warned would disincentivize investment in new treatments.
    "You have the real potential of having medicines not being
developed because it's far too expensive, or medicines that are
currently approved being withdrawn because they are political,"
Levin told Reuters.
    The FDA approved mifepristone, part of a two-drug regimen
that accounts for more than half of U.S. abortions, more than 
20 years ago and has determined its safety several times since.
    Health policy and legal experts have said that if
Kacsmaryk's unprecedented ruling is allowed to stand it could
undermine confidence in FDA's authority to regulate drugs,
severely weaken the agency, and hinder access to new treatments.
    "If courts can overturn drug approvals without regard for
science or evidence, or for the complexity required to fully vet
the safety and efficacy of new drugs, any medicine is at risk
for the same outcome as mifepristone," the letter said.
    The ruling could open the possibility to the banning of
vaccines and contraception for women, said Levin.
    "This is a nightmare scenario for the industry," he said.
"It's the single worst threat to the industry in over 50 years."

    <^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^
Texas judge in abortion pill lawsuit often rules for
conservatives     urn:newsml:reuters.com:*:nL1N35T038
ANALYSIS-Texas abortion pill ruling could undermine US drug
regulator     urn:newsml:reuters.com:*:nL8N36C098
EXPLAINER-Texas judge suspends approval of abortion pill. What
happens next?     urn:newsml:reuters.com:*:nL1N35P32Y
    ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^>
 (Reporting by Michael Erman in New York and Ahmed Aboulenein in
Washington; Additional reporting by Bhanvi Satija in Bengaluru;
Editing by Bill Berkrot)
 ((Bhanvi.Satija@thomsonreuters.com; Outside U.S. +91
9873062788;))