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FDA Exhibiting New Caution in Drug Approvals

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In a move that shocked Merck and Wall Street analysts last week, Merck’s new and long-awaited cholesterol drug—Cordaptive—was rejected by the Food and Drug Administration (FDA). Some leading heart researchers were not surprised, saying that the FDA is more reticent to approve new drugs in the wake of recent defective drug controversies and accusations the FDA might have approved several which were not fully tested.

“There is a shifting landscape in the medical community,” said Cleveland Clinic cardiologist Steven Nissen. Nissen’s outspoken criticism factored in painkiller Vioxx and diabetes medicine Avandia being withdrawn from market. 

”When you have a drug that has potentially widespread actions in the body, you would like to characterize its effects before using a drug in a number of patients,” he said. “There is a question if we know enough about a new drug to go forward.”

Merck and the FDA are not saying why Cordaptive was rejected, but Merck Chief Executive Richard Clark told analysts that the FDA’s concern “is all around the science.” Cordaptive is made up of a new medicine—laropiprant—and niacin, one of the B vitamins, which can be difficult to tolerate because of flushing, itching, and hot flashes. Laropiprant allegedly alleviates facial flushing; however, there have been no studies of laropiprant alone and its long-term effects are unclear. Merck and the analysts wrongly assumed Cordaptive was a shoe-in for approval since niacin is widely used and viewed as safe for raising good cholesterol—HDL. Because of its early confidence in Cordaptive, Merck placed “coming soon” advertisements in major medical journals as recently as November.

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