Recent Studies Prompt Debate About FDA Approval Process For New Medications

Armen Hareyan's picture

Recentstudies that raised questions about the benefits of the cholesterol medicationVytorin, manufactured by Merck and Schering-Plough, and the safety of the type 2diabetes treatment Avandia, manufactured by GlaxoSmithKline, are "reigniting debate"about the FDA approval process for new medications, the WallStreet Journal reports. House Energy andCommerce Committeemembers John Dingell (D-Mich.) and Bart Stupak (D-Mich.) on Thursday sentletters to the American Heart Association, the American College of Cardiology, Merck and Schering-Plough to requestinformation about Vytorin, and Sen. Chuck Grassley (R-Iowa) on Thursday began aseparate investigation into the medication.

According to the Journal, the "lawmakers' interest is thelatest sign that the flap over" Vytorin, as well as the safety concernsabout Avandia, "is adding new fuel to a long-running debate" aboutthe use of "surrogate markers" in the FDA approval process. FDAapproved Vytorin and Avandia in large part based on evidence that they helpedcontrol cholesterol and blood sugar levels, respectively, with those measures"believed to reflect important clinical benefits" that "serve asproxy markers, or surrogates, for the drug's broader and more important effecton the body," the Journal reports. The use of surrogatemarkers helps reduce approval times for new medications because "studiescan generally be shorter, smaller and cheaper," but the markers "canbe misleading," according to the Journal.


Grassley said that, "in light of what's happened with Avandia and Vytorin,maybe the FDA needs to re-examine when it's appropriate to use surrogateendpoints." He added, "These two cases also highlight the importanceof vigilant postmarketing surveillance and the need for more postmarketingstudies to address important safety questions." Stupak said that"people taking Vytorin are doing so because they believe it will reducetheir risk of heart attack." In addition, he said, "It would makesense for FDA to require manufacturers to conduct an endpoint study todetermine whether Vytorin just reduces cholesterol or if it also reduces heartattacks."

FDA officials said that they would examine the use of surrogate markers in theagency approval process. A "shift by the FDA toward tougher scrutiny ofnew drugs could add hundreds of millions of dollars to the cost of developing adrug at a time when some big drug makers are struggling to replenish productpipelines," the Journal reports (Wilde Mathews/Winslow, WallStreet Journal, 1/25).

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