Healthcare Reform: Obama Pushes for Shorter Data Exclusivity Period for Biosimilars

Many progressives and left-leaning individuals (like me) voted for President Obama because he presented himself as somebody who will stand up for what he believes. Until recently, I, along with others, have been deeply disappointed in his performance and it was no longer clear to me what he truly believes in. However, his recent stand on healthcare reform (sadly without a public option), his performance at the global warming summit and most recently his quick response and unequivocal support for Haitian earthquake victims suggest to me that we are finally beginning to see what President Obama believes and what he is made up. To that end, Obama has turned up the heat to reduce the proposed 12 period of data exclusivity for biosimilars (aka follow-on biologics) in the bill that was passed by both the US House and Senate. Both the President and Rep. Henry Waxman, D-CA (of Hatch-Waxman fame) are trying to reduce the 12 year exclusivity 10 years or less. Obama previously went on record saying that he favored a 7 year exclusivity period for biosimilars.

Not surprisingly, the move has met with fierce opposition from the pharmaceutical and biotechnology industries that argue the longer period is needed to encourage investment and R&D required to produce biopharmaceutical products. Lobbying by both sides has dramatically increased as healthcare reform is pretty much a done deal. However, brand companies have spent many millions more than generic manufacturers to lobby Congress on the 12 year period.

It is about time that an American President is willing to do what is in the best interest of the American public instead of what lobbyists and special interests are demanding. And, to those companies that steadfastly hold to the notion that biopharmaceuticals take an inordinately long time to bring to market I ask: “What’s in your pipeline?”

Until next time...

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