The FDA’s Pulse Quickens
After years of complaints that it was too protectionist, the Food and Drug Administration seems to have entered an era of faster approvals.
By Fran Hawthorne
FOR MUCH OF THE PAST DECADE, the pharmaceuticals industry and its investors privately griped that the U.S. Food and Drug Administration was too tough. In 2008 the agency unexpectedly rejected Tredaptive, a Merck & Co. medication for cholesterol that should have been a shoo-in, as it merely combined old-staple niacin with an ingredient to prevent flushing. Two years later the FDA drastically restricted the usage of Avandia, a diabetes drug made by GlaxoSmithKline that was already on the market. And obesity drugs? Forget it. Sanofi-Aventis Acomplia was rejected in 2007; Abbott Laboratories pulled Meridia from the market in 2010 under FDA pressure. Clearly, almost nothing could get past the nitpicking regulators.
With old blockbusters like Pfizers $11 billion cholesterol drug Lipitor going off patent and their replacements long delayed at the FDA, investors couldnt see much future in the sector.
But last year all of that seemed to shift: The agency approved 30 groundbreaking new drugs, compared with an annual average of just 22 over the previous half dozen years. Even more important in the FDAs view, a record amount 70 percent were okayed without first being sent back to the manufacturer for more work. Within two days this past January, two innovative drugs, Genentechs Erivedge for a type of skin cancer and Vertex Pharmaceuticals Kalydeco for cystic fibrosis, were waved through faster than anticipated. And in perhaps the ultimate symbol of change, the agency in late June approved Belviq from Arena Pharmaceuticals the first new diet drug in 13 years. ....