Procyclical Regulation at FDA?

From a year end WSJ piece entitled “Drug Approvals Slipped in 2010”: (my emphasis added)

A few potential blockbusters won approval during the year, but some of the most highly anticipated new products got delayed into next year or beyond. That partly reflects a tougher environment at the FDA, with regulators stepping up their scrutiny of safety issues in drugs for obesity, diabetes and other conditions.

According to monthly drug-approval reports on the FDA’s website, 21 new drugs were approved in 2010, down from 25 in 2009 and 24 in 2008, but higher from a recent low of 18 in 2007.

What’s going on is a kind of vicious circle, unfortunately. As the drug companies struggle to turn cutting-edge science into blockbuster products,  regulators get more skeptical. And as regulators get more skeptical, they tighten up their scrutiny, which makes the task of the drug companies that much more difficult.

Added. More on this subject from the San-Diego Union Tribune, 2010 drug approval extends frustrating trend for biotech companies,

Some people in the biotechnology industry have complained that FDA officials are putting too much emphasis on potential or perceived safety issues and aren’t giving enough attention to bringing innovative therapies to market.

“There has to be a balance, and that balance doesn’t seem to have been there over the last year or two,” said Joe Panetta, president and chief executive of the San Diego-based trade group Biocom.

The critics say the decline in new drug approvals has helped cut private investment in drug developers and prompted some companies to seek initial approval of their new therapies in Europe and Japan, where they face speedier and less onerous review processes.

“It could be that we shove the (biotechnology) industry to other countries and reduce the availability of breakthroughs” in the United States, said Tim Wollaeger, a managing director with the biomedical venture capital firm Sanderling Ventures.

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