Vytorin, Avandia raise doubt on FDA approvals

With recent studies raising questions about the safety of Avandia, and the benefits of costly cholesterol combo drug Vytorin, public debate has begun again as to whether the FDA's approval process for new medications is adequate. What's at issue, as controversy swirls around these and other challenged drugs, is whether the FDA should permit the use of "surrogate markers" in testing that allegedly reflect a drug's broader benefits. Drug makers like using these markers, as they can speed up approvals, but some observers argue that they aren't adequate.

As we noted yesterday [1], House Energy and Commerce Committee members sent letters this week to the American Heart Association and the American College of Cardiology, as well as drug makers Merck and Schering-Plough, to find out more about the medication. It's not clear yet whether a major crackdown is process, but it does seem likely that we're going to hear a lot of noise about this on the Hill in the near future.

To learn more about the controversy:
- read this Kaiser Daily Health Policy Report item [2]

Related Articles:
AHA backs costly cholesterol drug combo. Report [1]
Vytorin defenders funded by drugmakers. Report [3]
Vytorin, Zetia scrips plummet. Report [4]
Avandia gets black-box warning. Report [5]