In a post on the Hill's Congress blog, Jeff Allen, Executive Director of Friends for Cancer Research, discussed how reauthorizing PDUFA will address the current challenges facing the FDA's review process of new medicines. PDUFA was enacted to relieve the FDA of a serious backlog of potentially lifesaving new drugs, and in the years since its enactment, PDUFA has done just that. For example, the review time for new cancer medicines has dropped from fifteen months to just six months. However, as Allen says,
Today we face a different sort of crisis; the unsustainable reality that on average it takes 15 years and over one billion dollars to get a new drug to market. The scientific complexity of drug development has lead to continually increasing cost and time. If this is not resolved it will begin to reverse the positive trends in availability of new medicines for U.S. patients.
The research and development of new drugs is a complicated and extremely expensive process. Despite this barrier, American companies continue to invest billions of dollars in biopharmaceutical research, and the U.S. currently has more potential treatments in clinical trials than the rest of the world combined. Reauthorizing PDUFA will help the FDA and the biopharmaceutical industry address these challenges. From Allen's post:
In the coming months Congress will evaluate the new PDUFA proposal that includes vital elements needed to help address current challenges in drug development. If passed, the proposal would significantly enhance mechanisms for input to FDA. This includes opportunities for the agency to receive counsel from both scientific experts in the field, as well as patients who are experiencing a particular condition. The agreement would also expand channels for FDA output. The biomedical research community would greatly benefit from clear guidance from the FDA on acceptable strategies for new and innovative drug development.
We strongly believe that PDUFA will greatly improve the FDA's drug review process, holding the FDA accountable for speeding safe, innovative treatments to patients, and ensuring that the U.S. maintains its position as a global leader in the discovery of new treatments and cures.