Nearly 400 pharma and biotech executives, including Pfizer CEO Albert Bourla, signed an open letter that says the Texas federal judge’s ruling reduces FDA’s legitimacy|World Economic Forum|CC BY-NC-SA 2.0
Pfizer CEO Albert Bourla and ~400 pharmaceutical and biotech executives signed an open letter calling for reversal of the Texas federal judge’s ruling that invalidates the Food and Drug Administration’s approval of mifepristone.
Why?
The open letter says Judge Matthew J Kacsmaryk’s decision in the Texas case last week (that the FDA improperly approved the abortion pill mifepristone 23 years ago) reduces the legitimacy of the agency and creates uncertainty for all medications in the US.
Most of the execs represent companies that don’t manufacture mifepristone or any reproductive health drugs.
They believe, “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.”
In addition
The Justice Department filed a motion Monday seeking a stay in Judge Kacsmaryk’s ruling, citing its implementation could “severely harm women, particularly those for whom mifepristone is a medical or practical necessity.”
Mifepristone is also used to treat miscarriages in women.