Here's a post from PharmTech Talk discussing recent testimony by FDA's Margaret Hamburg before the House Committee on Energy and Commerce as it considered extending PDUFA (for the fifth time).
Is the US Facing a Pharmaceutical Manufacturing Gap?.
Hamburg cited numbers to show that the FDA had approved more new druigs for launch first (70% of last year's 35 new drugs) than other agencies in the world. In fact, 75% of the new drug approved in US and EMA between 2006 and 2010 hit the US first.
PharmTech noted that the US is the largest drug market at 36% of the world's total in 2010, while the top 5 EU markets accounted for another 17%, and the BRIC countries another 18%. But the question arose, does the US manufacture enough given its market position and importance? It turns out that 40% of the drugs consumed in the US are made outside the US, and 80% of the APIs used within are made ex-US.
The writer questions should the US support its internal manufacturing of drugs more? I would say, Yes, but with particular regard to supporting biomanufacturing. A lot of the drugs and APIs cited above are small molecules that have moved to generic status and have therefore graduated to lower cost (at least currently) areas of manufacturing outside the US. While it may be nice to retain some of that volume, I think it is more critical to keep the bio-drugs as a major focus in the US.
I think US government policy should look for ways to continue to support biotechnology in both discovery and manufacturing to help maintain our leadership position.
Posted by Bruce Lehr Feb 6th 2012.
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