FDA drug approvals soared in 2011, big year for GSK, J&J

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Safety-conscious U.S. regulators have taken part of the blame for the drug industry's monumental problems, many of which center on an inability to bring enough new products to market. But the FDA can point to 2011 as a year that saw a spike in drug approvals and the introduction of game-changing medicines that offer big revenue prospects for companies and benefits for patients.

The agency green-lighted 30 new drugs last year, a 7-year high for U.S. drug approvals—and a banner year for Johnson & Johnson ($JNJ) and GlaxoSmithKline ($GSK), each of which grabbed a trio of approvals, Bloomberg reported. Behind the increase in approvals were the agency's early meetings with companies before data were submitted, developers' improved focus on providing evidence of drug safety to regulators, and pharma groups making smarter decisions about which treatments to advance toward the market.

"I think people have realized that FDA has gotten more difficult and they're improving what they turn in," Citigroup analyst Yaron Werber told Bloomberg.

FDA Commissioner Margaret Hamburg trumpeted the increase in new drug approvals in late 2011, and the agency noted that it had been the first to give its nod to a number of novel treatments. U.S. regulators have spotlighted such treatments as Seattle Genetics' ($SGEN) new lymphoma drug Adcetris, approved in August, as an example of their efforts to streamline the review process to bring new drugs to patients.

Yet the pharma industry is hardly out of the hole it dug for itself during years of unproductive R&D, and many drugmakers are expecting some tough years ahead with generic competition for their top-selling drugs. We'll see whether the industry can stay on its 2011 pace for FDA approvals or sinks back to the low numbers experienced in years past.

- get more in the Bloomberg article

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