Emails Reveal Behind-The-Scenes Drama Of FDA’s Drug Approval Process
Last year, a fierce battle emerged over Sarepta's new muscular dystrophy drug, in which FDA official Janet Woodcock approved the treatment -- overruling the recommendations of a review team and an advisory committee. Newly released emails show what happened next.
The Wall Street Journal:
FDA Emails Offer Rare Look Into Internal Battle Over A Drug’s Approval
The Food and Drug Administration provided a rare glimpse of an internal battle that erupted last year over efforts to modernize the agency’s efforts to approve and regulate new drugs. In emails released by the FDA this week, an FDA official harshly rebuked the top agency official who drove the controversial decision to approve a drug to treat a form of muscular dystrophy. (Pulliam, 8/3)
In other pharmaceutical news —
The Associated Press:
FDA OKs New Drug To Treat All Forms Of Hepatitis C
U.S. regulators have approved the first drug to treat all forms of hepatitis C in as little as eight weeks. The pill combination from AbbVie Inc. was approved Thursday by the Food and Drug Administration for adults without significant cirrhosis, a type of liver disease, and many patients who were not cured by prior treatment. (8/3)
USA Today:
Martin Shkreli Is At It Again On Social Media As Verdict Wait Continues
What do you do if you're one of the most criticized defendants in the nation and the jurors in your criminal fraud trial finish their fourth day of deliberations without reaching a verdict? If you're "Pharma Bro" Martin Shkreli, you turn to social media, of course. (McCoy, 8/3)