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Backsliding at the FDA



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Congress keeps telling the FDA to speed up; it keeps finding ways to stay slow. Michael Astrue:

Patients are increasingly up in arms. Over 100,000 people have signed a White House petition to approve a promising new drug for Duchenne muscular dystrophy, a debilitating disease that right now will kill one boy of every 3,600 born in this country. Despite two Phase II studies that indicate the drug is quite safe and stimulates production of a protein essential to thwarting the devastating effects of this disease, the FDA has sent the sponsor back for more long and slow trials. Under the White House’s own rules, President Obama will have to respond publicly to the petition.

It takes no imagination to picture what is happening now at HHS. Its executive secretariat is almost surely circulating for comment a brief FDA-drafted statement for the president, which tries to express heartfelt sympathy for the dying young people while also claiming that there is nothing that the FDA can do about the situation.

The second half of that statement is a lie.



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