Given the number of sections of the Patient Protection and Affordable Care Act that read "The Secretary shall...", today's single-handed overruling by the Secretary of Health and Human Services' Kathleen Sibelius of the FDA's recommendation to permit the emergency contraceptive Plan B One-Step to go over-the-counter based on years of scientific analysis, should put us on notice. Recall that Ms. Sibelius has no medical or scientific degree. To my knowledge, today's action is unprecedented.
Could the FDA, with their requirements for funding from pharmaceutical companies to review cases like this, have a conflict of interest in regards to their decision?
Of course.
But such an autocratic, non-scientific veto by a single individual in charge of the entire United States' health care policy smacks of dictatorial power and should not be taken lightly by the scientific community or the citizens of this great country.
-Wes
Sure. It's absolutely political. I look forward to your column on my inability to get abortion and contraception insurance coverage.
ReplyDeleteNot surprisingly, just like the DICTATOR IN CHIEF! But, surprising out of line with his base.
ReplyDeleteI am no defender of the Obummer administration but decision by technologists is just as autocratic. Doctors and other technologists but not the only voice and not the deciding one. There are economic and moral dimensions that must be considered in addition to the "science".
ReplyDeleteNot *entirely* unprecedented. Bush bureaucrats initially blocked the introduction of Plan B as OTC for adults in the early-mid aughts. I recall some FDA chiefs resigning in protest. It wasn't as high profile since it wasn't the Sec of HHS who blocked it, but it was equally political.
ReplyDeleteIt was infuriating then and it's infuriating now. The difference, as best I can tell, was that the previous political obstruction was completely expected and in character with that administration's policies, whereas this is quite puzzling and a politically self-inflicted wound.