FDA Commissioner’s National Priority Vouchers Will Endanger Americans
WASHINGTON, D.C. – The Food and Drug Administration (FDA) has announced a program that will shorten review times assessing safety and efficacy for some new drugs to one to two months. Right now, typical review times are 10-12 months after the company’s final drug application and six months for priority reviews.
The “Commissioner’s National Priority Voucher” program is a very bad idea, with vague criteria about “companies supporting U.S. national interests.” It will likely be uncertain if drugs approved under this program are safe and effective. Importantly, Congress has not authorized the new program by enacting legislation, as has been the case for previous FDA priority review voucher programs.
“The priority voucher program is not a ‘common sense’ approach as the FDA Commissioner claims, but a dangerous one,” said Public Citizen Health Research Group Director Dr. Robert Steinbrook. “Research has shown that when the FDA rushes to review and approve new drugs, there is a higher likelihood that these drugs will have safety problems after approval. The voucher program will only be a boon for Big Pharma at the expense of the American public and will likely bypass the agency’s advisory committee process that allows for outside independent input.”
“The Trump administration has already gutted significant technical and scientific capacity at the FDA that has led to delays in drug development and review and raised concerns about the safety of our drug supply. Now the Commissioner is forcing the FDA to use its limited resources to rush through reviews of new drugs for unclear reasons. Corners are likely to be cut. How can patients and clinicians trust that drugs approved with one to two months of review are truly safe and effective?” said Dr. Reshma Ramachandran, a member of the Board of Directors of Doctors for America.