The FDA Approved How Many New Drugs?

The FDA Approved How Many New Drugs?

November 4th, 2011 // 12:22 pm @

Why not take an opportunity to crow when the numbers are going your way? That is what the FDA is doing today with a new report that trumpets that 35 new medicines were approved over the past 12 months, which is nearly the highest number of approvals in the past decade. The only year in which the agency issued more approvals was in 2009, when there were 37 such endorsements.

The FDA also boasts that approval times are faster than elsewhere – 24 of the 35 newly approved drugs occurred in the US before any other country in the world and also before the European Union. “Thirty-five major drug approvals in one year represents a very strong performance, both by industry and by the FDA, and we continue to use every resource possible to get new treatments to patients,” says FDA commish Margaret Hamburg in a statement.

The report was, of course, released to counter critics who say the FDA is out of step with the needs of the public – and drug makers, too. Ever since the Vioxx scandal raised safety concerns, the agency has been criticized for pushing the pendulum too far in the other direction, a shift that some say was accelerated after Hamburg was named commissioner.

To rebut the naysayers, the agency tried to make a splash today by not only releasing the report, but also holding a media briefing to review the results. And the results are neatly packaged to contain bullet points that underscore not only the number, but the type of accomplishments involving drug approvals. Here are a few…

Of the 35 approvals, two are “breakthroughs” in personalized medicine that were approved with a diagnostic test; seven provide major advances in cancer treatment, according to the agency; 10 are for orphan diseases; 16 were approved under priority review; two-thirds were completed in a single review cycle; three were approved under accelerated approval, and 34 were approved on or before the agreed-upon review time targets, including three cancer drugs approved in less than six months .

Source: Pharmalot


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