Monday, February 11, 2008

Starring Role for Follow-On Biologics

You have to hand it to the players in the follow-on biologics debate: they are pulling out all the stops. Just when you thought you thought you had seen everything, it shows up on YouTube.

The Richmond, Va.-based biotech company Insmed Inc. posted a video (below) on YouTube starring Mike Coleman, an Insmed scientist who exhorts the values of follow-on proteins, and encourages others to post their thoughts on the issue as well. The video, "Follow-On Biologics--Tell your Story," has been viewed about 1,000 since Insmed posted it on February 8.

Insmed already markets the insulin-like growth factor mecasermin (IPLEX), and wants to position itself as the first US marketer of follow-on biologics--when and if Congress gives the Food & Drug Administration the green light to establish a regulatory pathway.

The issue died down after Congress failed to attach a measure to the FDA Amendments Act last year, but was back in media reports last week after President Bush mentioned follow-on biologics in his FY 2009 budget request.

That annoucement had its own YouTube-like quality when Jim Dyer, the agency's operations chief, had to correct statements that FDA would be forwarding legislation to Congress on a regulatory pathway this year. Instead, the agency will continue helping Congress develop a bill--and the budget request is only intended to express the Administration's eagerness to see the legislation enacted this year.

We're not sure how many congressmen watch YouTube, but their staffers are sure to be clued in. Will the Internet ad be just a fun cocktail party story? Or will it prod Congress back into action? Check back to find out.

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