New Drug Approvals Fall in 2010 as Safety Concerns Slow U.S. FDA Decisions

Twenty-one new drugs were approved in the U.S. this year, the fewest since 2007, as the Food and Drug Administration showed more willingness to delay or reject medicines with potential safety risks.

The tally, compiled by Bloomberg from an FDA database, compares with 25 approvals last year and 24 in 2008, according to the FDA’s website. Nineteen new drugs were cleared in 2007, the fewest in 24 years.

Today marks the last regular work day of 2010 for the U.S. government. This year, the FDA also restricted the use of London-based GlaxoSmithKline Plc’s diabetes pill Avandia and withdrew from the market the weight-loss drug Meridia made by Abbott Park, Illinois-based Abbott Laboratories. The agency citied heart complications in both actions.

“There’s a sense that the FDA is being more cautious,” said Les Funtleyder, a fund manager at Miller Tabak & Co. in New York, in a telephone interview. “If the rules get too onerous, it could potentially keep innovative drugs out of U.S. hands.”

To contact the reporter on this story: Catherine Larkin in Washington at clarkin4@bloomberg.net.

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net.