March 29, 2024
Clinton abused powers on
abortion drug
COMMENTARY
OPINION:
While the Supreme Court analyzes the technical legal standing of
pro-life doctors to sue the Food and Drug Administration over the chemical abortion pill
mifepristone, the case holds the potential to highlight the health dangers to
women posed by the drug and its politically prompted approval (“Supreme Court justices weigh rolling back use of the
abortion pill,” Web, March 26).
When I worked with these doctors and pro-life
advocates in 2002 to help draft the original “Citizen Petition” complaint
against the FDA‘s politically tainted fast-tracking of the drug, we noted that
the “FDA's violation of its standards and rules have put women’s health
and lives at risk.” We detailed how the FDA waived its own rules in fast-tracking the drug (such as
not requiring testing on minors). The FDA also developed a drug regimen inconsistent with clinical
trials. Transvaginal ultrasounds that can date a pregnancy and rule out
dangerous ectopic pregnancies, for example, while employed in the U.S. clinical
trial, were not required under the FDA's regimen.
We also revealed the intense lobbying for the
drug by the Clinton administration, first to bring what was then a French
abortion pill to the U.S. and then to fast-track its approval by the FDA.
We highlighted the disturbing fact that
“President Clinton reportedly wrote to [French abortion pill manufacturer]
Hoechst asking the company to file a new drug application with the FDA—an unprecedented situation in the pharmaceutical industry—which
Hoechst intransigently refused to do.” Undeterred, the Clinton administration,
with Health and Human Services Secretary Donna Shalala leading the campaign,
worked feverishly to get the drug’s patent rights transferred to an American
company, which then hired a Chinese manufacturer to produce the drug.
Ultimately, the FDA illegitimately and perversely deployed Subpart H—a
fast-track mechanism developed for rapid approval of drugs for life-threatening
illnesses such as HIV—to approve a life-ending abortion drug.
Whatever the court decides regarding the legal standing of pro-life doctors
in this lawsuit, nothing will change the dangers posed by the drug to women or
the dangers posed to the American public by a politicized FDA.
JONATHAN IMBODY
