Mylan's EpiPen Nightmare Not Over Yet, But Will Congress Just Write?
Unless Republicans are convinced the market can't fix the problem, Mylan officials may only get congressional letters on the EpiPen price increase.
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Bradley Thompson has been shepherding the Combination Products Coalition for more than a decade. In a recent interview, he said the recent policy spotlight on the combo-products space, including in a recent user-fee deal, is a welcome development after a period of neglect. He also spoke about the numerous reforms in the works and the state of the sector.
If you were an FDA official, would you prefer to be a sideshow at a contentious House committee hearing or the focus of a cordial Senate one?
In response to Congressional questions about whether FDA is a barrier to competition for the epinephrine product, CDER Director lays out what could be required to prove an injector device problem is fixed.