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  • Writer's pictureJohn Q Leonard

FDA Approvals Up Last Year: Good for Medicine, Bad for Pharma

There are stark differences between the two years that saw the highed number of new molecular entities approved by the FDA, 1996 and 2014. Last year had only 8 fewer approvals than did 1996, a year that came after new legislation provided resources to the FDA enabling the organization to make faster decisions on what at the time were backlogged new drug applicaitons.

  • 13 companies accounted for 21 of the 53 NMEs approved by the FDA in 1996

  • 1996 was a year of blockbusters like lipitor

  • It was dominated by small molecules

Hyper-innovation? Well, I am glad to see those 360,000 layoffs in Pharma in the past 12 years did the industry a great service. I imagine those from R&D now working elsewhere from Pharma and Biotech are much relieved and hyper-glad. I can't wait to hear how the management consulting firms are going to spin this all into dulcet tones for the ears of Pharma management. Does 2014 bust out of Eroom's law and reverse the trend?

Time will tell if it is a hyper-harbinger, but I rather doubt it. On the other hand, I am glad that there are some good drugs in the mix... and some day they might be generics.

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