How AIDS Advocates Led the Way for PDUFA


Life science is a field with many twists and turns, but one fact always rings true: medicine only works when it can reach those who need it. This is especially important now, after recently observing World AIDS Day and throughout December, often recognized as AIDS Awareness Month.

The same truth guided the Prescription Drug User Fee Act (PDUFA) more than 25 years ago. The height of the AIDS epidemic in the 1980s catapulted the lengthy review of medicines into the spotlight. At the urging of AIDS activists and advocates, the Food and Drug Administration (FDA) accelerated the review of AZT, the first medicine known to treat HIV. Lawmakers, advocates and scientists, realizing that speed must be the norm rather than the exception, came together to propose legislation that would create new processes at the FDA to deliver medicines to patients faster.

Since then, PDUFA has been a key component of our country's health care system. From the time scientists discover a medicine to the point when the FDA approves it for public use, patients live each day with degenerative and life threatening diseases. PDUFA makes it possible for the FDA to decrease the turnaround time on new medicines, hire highly qualified staff, closely monitor the performance of medicines and other functions that were not previously possible.

As a nation, we continue to face very real health problems. More than 1.2 million Americans are HIV positive. Over 5 million are suffering from Alzheimer's disease. Seven million have some form of cancer. None of these diseases has a known cure - and so we must continue to search for treatments. Enhancing the FDA's capabilities is crucial to making that happen.

Of course, the first step in the world of medicine is discovery. But the next steps, review and regulation, are just as important. We must keep this in mind as we head toward another renewal of PDUFA in 2017. When scientists, doctors and regulators work in unison, we have a chance of fighting back against the diseases that plague us and our loved ones.