The U.S. FDA has issued a not-approvable letter to Merck for an OTC version of the statin Mevacor. Previously, the FDA had issued an approvable letter, but has been “reviewing” the application since 1999.
The agency wants additional safety and enhanced product labeling before approving the application. In December 2007, the independent FDA advisory committee voted 10-2 to reject OTC Mevacor. In light of the recent brouhaha over statins and Vytorin, the FDA decision was certainly expected.
Back in the 1990’s, “harmonization” was all the rage. Drug standards were going to converge between the U.S. and the EU, enabling cheaper drug approvals for companies and better data for governments. A secondary goal was to also eliminate embarrassing disparities in drug access for governments with socialized medicine.
However, harmonization hasn’t materialized. As evidence, back in May 2004, the UK approved Zocor (simvastatin) for OTC use. The move of statins to OTC was beneficial to the UK budget where the NHS has been able to shift some of the cost burden over to consumers.