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Perpetual Exclusivity
RA Guy on January 13th, 2011

Biologics CostA year and a half ago, during the great “health care reform” debate, I was startled by a little-discussed provision in the proposed legislation that was going to grant an extended period of exclusivity (i.e. protection from generic competition) to biotech firms. According to what I was reading in the press, the aim of these new laws was twofold: 1. ensure that the companies continue to innovate by ensuring that they are able to recoup their considerable research & development costs, and 2. protect consumers from the “inherent” unsafety of generic biologics.

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Jeff Levin-Scherz from Managing Healthcare Costs:

“These Senators are asking the FDA to make a decision that would be very good indeed for the biopharmas – but would increase the future cost of health care. This kind of decision would likely also diminish innovation, as firms tasked their scientists to protect expiring patents, rather than to develop novel treatments.”