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Drugmakers are taking advantage of a speedier process at the Food and Drug Administration resulting in more drugs getting the green light in the United States.


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3/25/2015
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Drugmakers are taking advantage of a speedier process at the Food and Drug Administration resulting in more drugs getting the green light in the United States.

Through March 19, the FDA has approved 10 new drugs, which matches the pace of last year’s total of 41 approved drugs.

Between 2010 and 2014 the FDA approved 37 cancer drugs, compared to just 19 between 205 and 2009. This year it has already approved four more.

Of last year’s 41 new approvals, 9 were designated as innovative drugs. 18 more drugs benefited from other mechanisms for speedier reviews.

This year’s 10 approvals include the first medicine in years for initial treatment of a common form of advanced breast cancer.

According to analysts and industry executives, the quicker process is in part due to the 2012 mandates from Congress. The speedier process is spreading investor and drugmaker optimism by boosting innovative drugs that promise the biggest benefit.

Other drugs that are on track to becoming approved are two medications that may cut heart attacks and other cardiac events in half for patients with high cholesterol.

A trial for a skin cancer drug Keytruda was stopped early because patients who received it as a first treatment for advanced melanoma lived longer than those who received standard therapy.  

The FDA culture is also changing; administrators see themselves as catalysts for innovation. When a trial showed that a skin cancer drug, Opdivo, could extend survival in a hard-to-treat type of lung malignancy, the FDA’s top official for cancer drugs was alerted by statisticians weeks before Bristol-Myers Squibb executives knew about the data. This resulted in the approval for the lung-cancer use more than three months ahead of the FDA’s deadline to act.

The downside of this new speedy system is that it could lead to too many drugs on the market offering only incremental benefits, less investment in research and development and insurance companies refusing to cover them.

 

 



Category: Misdiagnosis and Failure to Diagnose


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