Monday, July 13, 2009

Generic biologics - is 12 years too long to wait?

In case you haven't been paying attention, there was great debate in Washington regarding the potential for generic biotech drugs. Why is this such a key issue? Well, two reasons: 1) These drugs are really expensive; 2) The government pays for most of these medications through Medicaid and Medicare.

To this point, law has not allowed for generic production of such biologic drugs (think Procrit and Neupogen). However, some politicians seeing the potential financial risk the government would have in the coming years with more and more of these agents being used, decided to promote a bill that would allow for generic production of such medications. We applaud that part of the story.

Sen. Kennedy proposed 13 1/2 years of exclusivity (the time in which a drug could be marketed before a generic could be sold). Several other U.S. Senators wanted a period of 7 years. The generic drug makers want it to be 5 years. The brand drug companies want it to be 500 years (or never).

In the end, it appears that the politicians have agreed to allow 12 years of exclusivity. It's much longer than I prefer because of my experience with drug costs impacting patient care, but it's better than no generic biologics which is what we currently have.

Please share your thoughts if you have any.

WSJ article / blog: http://blogs.wsj.com/health/2009/07/13/when-should-biotech-drugs-face-generic-competition/

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