Regulatory Focus™ > News Articles > FDA Drug Approvals Up 42% in 2011, Regulatory Quality Highlighted

FDA Drug Approvals Up 42% in 2011, Regulatory Quality Highlighted

Posted 05 January 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) approved 30 new molecular entities (NMEs) during 2011, marking a 7-year high for the agency, according to an analysis by Bloomberg.

Notable success stories include Johnson & Johnson and GlaxoSmithkline, both of which tripled their approvals from the year prior.  The entire industry, however, may stand to benefit from the 42% increase in approvals as patent expiries begin in earnest this year. Twenty-one patented medicines worth $11.5 billion dollars will face generic competition starting this year, with expiries continuing for the next several years.

Newly-approved medicines that are expected to be blockbusters include Yervoy (Bristol), Xarelto (J&J), and Benlysta (GSK/Human Genome Sciences).

The reason for the spike in approvals is unclear, however. FDA Center for Drug Evaluation Research (CDER) Director Janet Woodcock noted that the novelty of the products is allowing FDA to take a more flexible approach, while financial analysts at Citigroup and Arcoda Capital Management pegged the FDA's successes rate to companies focusing on regulatory quality before submitting applications to the FDA.

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

GlaxoSmithkline's Chief Regulatory Officer Paul Huckle mirrored that assessment, saying that he thinks, "companies are being a lot more selective around where do they invest their own resources and where can they make the most impact."

A higher number of submissions, too, may be behind the rise. Companies submitted seven more New Drug Approval (NDA) applications in 2011 (29) than in 2010 (22)-an increase of 32%.

FDA's negotiations with industry over the prescription drug and medical device user fee acts (PDUFA and MDUFA) may also play a role in the increase, notes Bloomberg.

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