HHS and FDA update their response to request from more than 20 state attorneys general to study the adverse consequences of mifepristone
Slowly but surely strong requests from pro-life organizations such as National Right to Life and many pro-life state attorneys general to investigate the safety of mifepristone are getting encouraging feedback from HHS Robert F. Kennedy, Jr. and FDA Commissioner Martin Makary.
In a letter dated September 19, reposted at The Gateway Pundit, Kennedy and Makary acknowledged the letter sent by more than 20 attorneys general on July 31 and gave an update of their review of the chemical abortion technique that accounts for well over 60% of all abortions performed in the United States.
Kennedy and Makary state up front
HHS is committed to studying the adverse consequences reported in relation to mifepristone to endure the REMS [Risk Evaluation and Mitigation Strategy] are sufficient to protecting women from unstated risks.” ….
To that end, HHS—through the FDA—is conducting its own review of the evidence, including real-world outcomes and evidence, related to the safety of the drug. Given the 2016 FDA decision to eliminate the REMS requirement for certain prescribers to report non-fatal serious adverse events to mifepristone sponsors, this review will contribute to the understanding of the drug’s safety profile.
Their letter went through the chronology of prior FDAs which moved from requiring relatively strict requirements in 2000 all the way to eliminating in-person visits. The agency’s REMS, intended to safeguard women’s health, has been reduced to a shell of itself.
Mifepristone’s dangers have been reported by the FDA itself. The letter notes that between 2000 to 2012, there were “2,740 adverse events, including 415 events involving blood loss requiring transfusions.”
The deaths of at least 36 women have been associated with the use of mifepristone.
The Kennedy/Makary letter refers to the Ethics and Public Policy Center study which “indicate potential dangers that may attend offering mifepristone without sufficient medical support or supervision.”