REMARKS BY FRANK J. OLDHAM, JR.
PRESIDENT AND CEO OF NAPWA
ON REAUTHORIZATION OF PDUFA

Good morning!

I am Frank J. Oldham, Jr., President and CEO of NAPWA – the National Association of People With AIDS. Founded in 1983, NAPWA is the oldest national AIDS organization in the United States and in the world and represents the estimated 1.2 million Americans living today with HIV.

I am one of that 1.2 million. I have lived with HIV for twenty-two years.

In those years, I have seen new medicines transform HIV from a death sentence into a manageable chronic condition – for those who are lucky enough to have access to the drugs.
NAPWA and I personally support reauthorization of PDUFA because the user fees it authorizes support a reliable, safe and speedy process for testing and approving the new medicines that people living with HIV and other serious conditions need.

PDUFA V provides for increased industry fees to provide even more support for faster and more predictable review of new medications. Regulators support this because it pays the salaries of the scientists and administrators they need to perform their legislatively mandated function of approving new drugs and therapies.

Industry supports this because it helps them bring their products to patients sooner.

Consumers and patients, including the 1.2 million Americans living with HIV whom NAPWA represents, support this, because a faster approval process gives them earlier access to new drugs they need right now. Those of us who live with HIV know that early access to new drugs can be a matter of life and death. Since 1992 when PDUFA was first enacted, the average approval time for new medications decreased by more than half. The same decade has seen the welcome flood of new HIV antiviral medications that have changed HIV from a death sentence into a serious but survivable condition. Many of us are still here because PDUFA works.

PDUFA V not only supports a faster testing and review process, it also encourages innovative basic medical science by providing an environment in which scientific review tools keep pace with the basic science, and a predictable review process that gives researchers and investors better prospects of seeing promising developments through to commercialization. As an effective HIV preventive vaccine and a “functional cure” for HIV – either of which could save the public sector billions – remain tantalizingly just out of reach, we at NAPWA call attention to the importance of this research and the need for a regulatory climate that supports it.

PDUFA V also takes important new steps in requiring Risk Evaluation and Mediation Strategies (REMSs) and long-term pre and post-approval drug safety monitoring. We are entering an era when HIV antiviral drugs will be used for prevention as well as treatment of HIV, with risks for HIV-negative individuals who take them but great promise for general public health. We need enhanced REMS protocols to ensure fair evaluation of risks and effective strategies for minimizing them. And we are already well into an era when Americans who begin taking HIV antivirals for treatment or protection may be taking them for decades. PDUFA V’s long-term safety-surveillance provisions are a welcome step forward.

PDUFA V is one of those very rare issues where regulators, industry, and patients are all asking for the same thing. We hope the lawmakers who represent the same 1.2 million Americans living with HIV that NAPWA serves, and indeed all Americans, will enact PDUFA V swiftly and as designed when it reaches Congress.

Thank you.


Frank J. Oldham, Jr.
President and CEO