BIO Expresses Concerns with Medical Innovation Act

Washington, DC – January 30, 2015 – Today, the Biotechnology Industry Organization (BIO) expressed serious concern with the Medical Innovation Act introduced by Senator Elizabeth Warren (D-MA). The legislation proposes to increase funding for the National Institutes of Health (NIH) by creating a new statutory scheme that would impose a fee on biopharmaceutical companies working on critical treatments and cures for patients.

The following can be attributed to Jim Greenwood, President and CEO of BIO:

“While we greatly support the idea of increased funding for NIH, we have serious concerns about the impact that this legislation would have on the research and development of new treatments and cures.

“The legislation seeks to impose an ‘innovation fee’ on drug developers that enter into settlement agreements with the government. In actuality, this legislation would impose a tax on innovation, which would inhibit and delay medical innovation and, in effect, harm those patients waiting for cures.

“There are many legitimate reasons a person or a company would settle a case with the government, or any other party. Settlements avoid future litigation expenses, ensure predictability, reduce disruption and provide finality. Settlements do not necessarily mean that anyone did anything illegal or operated in bad faith – and thus there is no logical basis upon which to impose a fine or fee just because of the act of settling with the government.

“A settlement agreement can be an important method of resolving a case with the government, rather than incentivizing the waste of additional governmental and private sector resources resulting from avoidable litigation. Unnecessary litigation means fewer resources for manufacturers to devote to investing in the research and development of new therapies intended to better treat or cure patients suffering from disease.

“Further, by tying the tax to prior NIH involvement in the drug discovery or development process, the bill would create a chilling effect on NIH-industry collaborations at the very moment in time when Congress and the Administration are trying to increase such collaborations to help patients suffering from unmet medical needs.

“The best approach is for the Congress to work together on a bipartisan basis to increase appropriations for NIH. These vital institutes need to be better funded – this is something on which we all can agree.”

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