October 2nd, 2007
Editor’s Note: The following letter from Sen. Sam Brownback (R-KS) was originally published in the September/October 2007 issue of Health Affairs. The letter describes Sen. Brownback’s use of a Health Affairs paper as the basis for his Elimination of Neglected Diseases (END) amendment to the FDA Revitalization Act. President Bush signed a version of the legislation and the END amendment into law on Sept. 27, 2007.
A paper by Duke University economists David Ridley, Henry Grabowski,and Jeffrey Moe (Mar/Apr 06) highlights the devastating effect of neglected diseases on people in developing countries. It also proposes an innovative approach to combating neglected diseases: providing incentives for drug companies to bring treatments for such diseases to market.
I have seen firsthand the horrific effects of neglected diseases on impoverished African communities, and as a U.S. Senator and a passionate humanitarian, I have attempted to draw attention to the need to combat neglected and tropical diseases. For instance, last year I introduced legislation in the Senate that was designed to provide incentives for drug companies to produce treatments for neglected and tropical diseases; it would have extended patents for up to two years for existing lifestyle drugs to companies that produced a treatment for a neglected or tropical disease. It did not happen, however. Because of the aversion to extending pharmaceutical patents, I encountered major opposition in the Senate, where the bill languished.
So this paper—and its proposal—caught my attention. The incentive structure proposed by Ridley and colleagues avoids the political divisiveness of pharmaceutical patent extensions. Instead, it creates an incentive structure based on a “priority review voucher” that could be applied to a drug in a company’s pipeline in return for bringing a treatment for neglected or tropical disease to market.
After reading their proposal in Health Affairs, I met with Ridley and colleagues to discuss the idea further, and I subsequently drafted an amendment to the Food and Drug Administration Revitalization Act (S. 1082). Indeed, their idea is the heart of my Elimination of Neglected Diseases (END) amendment; furthermore, their phrase “priority review voucher” is the term in the amendment that is coupled with products to fight tropical diseases.
My amendment, which was cosponsored by Sen. Sherrod Brown (D-OH) and Sen. Joseph Lieberman (D-CT), was adopted into the Food and Drug Administration Revitalization Act. I am hopeful that this amendment will soon become public law, and I am glad to be able to play a role in making the Duke economists’ intriguing proposal into a life-saving reality.
Sen. Sam Brownback (R-KS)
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