The Taxpayers Protection Alliance (TPA) released a report on Mar. 26 titled “Blocking Breakthroughs: Delays and Denials at the FDA,” which examines issues in the Food and Drug Administration’s (FDA) drug approval process. The release comes during ongoing debate over recent FDA decisions, including its refusal to review Moderna’s application for its first mRNA seasonal flu vaccine.
The report addresses concerns about the agency’s criteria for drug approvals, describing them as unrealistic and ethically problematic. It also notes that Vinay Prasad, Director of the FDA Center for Biologics Evaluation and Research who played a role in these decisions, will soon leave his position.
Ross Marchand, Executive Director of TPA, said: “For too long, the FDA has stood in between patients and life-saving treatments. New leaders at the helm of the Department of Health and Human Services (HHS) and FDA, such as Robert F. Kennedy Jr. and Dr. Marty Makary, have promised to make America healthier and bolster patient access to care. This report shows that is simply not happening, and millions of Americans are paying the price. Bureaucrats need to get out of the way and put patients first.”
Marchand also said: “There are plenty of steps the FDA and Congress can take to improve the drug approval process and expand access. Promising reforms include approval reciprocity with other nations, embracing a wider variety of outcomes-based data, and allowing more medications to be sold over the counter. With the right combination of changes, long-stalled drugs can finally come to market and be easily accessed by patients.”
He concluded: “It’s long past time for FDA reform. Policymakers need to step up and do right by patients. Millions of Americans will benefit from a faster and more reliable drug approval process.”
Washington D.C.-based Taxpayers Protection Alliance Foundation is a non-profit organization that advocates for government transparency through educating the public via research, investigative reporting, and analysis about excessive taxation or spending by all levels of government; it was founded in 2011 with David Williams serving as president.
