The right-leaning Manhattan Institute launched a new initiative on Tuesday to push for reform at the Food and Drug Administration, in part by speeding drug reviews. The think tank, which advocates for free-market policies, named former FDA commissioner Dr. Andrew von Eschenbach to chair the project.
Eschenbach, also a former director of the National Cancer Institute, immediately called on Congress to “remake—not merely tweak” FDA.
“Over the years, Congress has repeatedly expanded the FDA's responsibilities, and today the agency monitors products that account for 25 cents of every dollar in U.S. consumer spending—including tobacco, the food supply, cosmetics, and drugs ranging from aspirin to the latest biotech medicines for patients and pets,” he writes in a commentary in The Wall Street Journal.
“It has not ensured that the agency is keeping pace with the enormous scientific advances made since the human genome was decoded in 2000. Congress and the Obama administration need to make that a priority.”
Legislation that has drug and device makers pay FDA to review their products—money that makes up a big hunk of the agency’s funding—is currently under review on the Hill for renewal.
“This presents a rare opportunity to examine the FDA's overall needs and performance,” Eschenbach wrote. “Congress should not only set the fees and add resources for the agency but also modernize it from the bottom up.”
For instance, Eschenbach said trials of a new approach called regenerative medicine could and should go ahead in paying patients—in place of current standard practice in which labs test experimental drugs and procedures in volunteers first for safety and then in two stages to show whether they work.
“Instead, after proof of concept and safety testing, the product could be approved for marketing with every eligible patient entered in a registry so the company and the FDA can establish efficacy through post-market studies,” Eschenbach suggests.