The drug company Merck is suspending sales of its cholesterol drug Tredaptive and asking doctors not to prescribe it due to the drug’s ineffectiveness and some non-fatal side effects. What’s most interesting here to me is that U.S. consumers have nothing to fear: the drug was available in the European Union, but not here. FDA scientists rejected it in 2008.
When Congress debated FDA legislation last year, some falsely claimed that the U.S. is slower than the European Union in approving new medications. The data showed this isn’t true.
Nevertheless, when the U.S. fails to approve a drug that the European Union considers safe and effective, there are rumblings of protest. In a 2008 CNBC article, reporter Mike Huckman wrote that Schering-Plough Chairman and CEO Fred Hassan told him he “believes the regulatory, political and media environment in the U.S. is putting the country at risk of ceding its drug innovation leadership position to overseas.”
When the FDA decided not to approve Tredaptive, the agency asked Merck to provide data from a study known as HSP2-Thrive—the very study that has led to the drug’s withdrawal.
It turns out that sometimes, FDA scientists see what their counterparts across the pond do not, and decide to ask for more data before making a drug approval decision. Kudos to the FDA for exercising restraint.
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