HealthHIV Urges Senate to Keep Politics Out of PDUFA

Washington, D.C. (May 17, 2012)Health HIV, the non-profit organization serving people living with or at risk for HIV/AIDS through education, technical assistance and health services research, today sent a letter to Senator Tom Harkin (D-IA), Senator Michael B. Enzi (R-WY) and several members of the Health, Education, Labor, and Pensions Committee urging the Senate to keep politics out of the reauthorization of the Prescription Drug User Fee Act (PDUFA).


In the letter, James Sykes, advocacy manager of HealthHIV, sites how the availability of more effective treatment options as a result of PDUFA have improved the quality of life for patients living with HIV/AIDS.


“Since the beginning of the global HIV/AIDS epidemic, the Food and Drug Administration (FDA) has played the central role in shepherding new life-saving drugs. The FDA, initially through an accelerated approval process, which eliminated undue delays, helped to bring to the market the first drug found to be effective in treating HIV/AIDS.  As a result, a diagnosis of HIV is no longer the death sentence it once was in this country.” 


The letter goes on to illustrate why it is vital that PDUFA remain in its current form and that the Senate not allow anything to jeopardize this sound policy and thus create major uncertainty at the FDA.


“We think it is imperative that the Senate act quickly this week to pass the Prescription Drug User Fee Act (PDUFA), which has moved through each step of the legislative process with overwhelming bipartisan support.  With over 1.2 million Americans living with HIV and an average of 56, 400 new infections each year, which equates to one infection every 9 and a half minutes, now is not the time to delay reauthorization of this vital law. 


“We call on you to fulfill your responsibility and vote to pass this legislation without delay.  Whether it is HIV/AIDS or another life-threatening disease, literally millions of patients stand to benefit.”












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