In the United States, biologics are not regulated under the Hatch-Waxman Act, which governs approval of conventional generic "small molecule" pharmaceuticals. Current U.S. health care reform bills include provisions intended to introduce a mechanism to regulate approval of subsequent entry biologics. Current House and Senate bills provide the innovator biologic drug with 12 years of exclusivity, even absent patent protection. This 12 year period received broad bipartisan support in both chambers. President Obama is now signaling that he would like to see this exclusivity period truncated to a rumored range from seven to ten years, presumably as another means of containing costs in his plan for health care reform. The pharmaceutical industry has reiterated the need for the 12 year exclusivity period to recoup development costs and fund further research.

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