Here's a piece republished in its entirety from Bloomberg.
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.”
My comments is that the drug makers and agency still need to work harder at collaboration during the drug development process and in defining data needed from clinical trials and designs needed to generate same. The industry is struggling enough with a withering R&D pipeline. It really cannot afford to have drugs go down as frequently as has been the case in the past few years in phase III. Also, there needs to be a reality check by industry to NOT put drugs into late stage clinicals that do not have a chance to better the results of products that are already out there. In many cases, we simply need to be testing better drugs that are designed to deliver better benefits.
Posted by Bruce Lehr December 31st 2010.