As we noted last month, former Food and Drug Administration (FDA) Commissioner Andrew von Eschenbach, M.D., wrote an op-ed in the Wall Street Journal calling on Congress to give FDA necessary resources to bring the agency into the 21st century. Dr. Eschenbach currently serves as the chairman of the Manhattan Institute’s Project FDA.
In another recent opinion piece in the Wall Street Journal, Eschenbach further noted how Congress “has starved [FDA] of funds, limiting its scientists’ ability to keep up with peers in private industry and academia.”
As a result, he asserted that it would make “far better sense for the FDA to work collaboratively with physicians, patients, companies and academic researchers to craft standards for evaluating new technologies while they are still being developed, not years later when a company makes a marketing application for a breakthrough product.” Such a process is needed because “FDA scientists typically have little contact with the scientists who know the most about these innovative technologies.” Moreover, “the agency’s process for regulating complex new technologies often starts too late, after companies and researchers have sunk millions of dollars and thousands of hours into painstaking research.”
Why do FDA scientists not have contact with such experts? Eschenbach explained that, “consumer groups distrustful of industry have led Congress to erect ever greater barriers between regulators and those they regulate.” While “FDA can convene advisory committees of outside experts, these experts weigh in only at the end of the regulatory process.”
Even “worse, congressionally mandated conflict-of-interest rules keep many of the most knowledgeable academic and industry scientists off advisory committees out of fear that industry ties might bias their judgment.” Eschenbach’s comments echo those of current FDA Commissioner Margaret Hamburg, MD, and FDA Center for Drug Evaluation and Research (CDER) Director Janet Woodcock, MD. Although both Woodcock and Hamburg have somewhat toned down their comments about the overly strict conflict of interest rules the agency enforces on FDA advisory committees, several pieces of legislation that will be considered in the upcoming user fee act negotiations would relax those rules.
To address this issue, Eschenbach recommended that Congress “make conflict-of-interest restrictions more rational, to ensure that agency staff can get early access to external scientific expertise to evaluate emerging technologies.” He asserted that, ‘FDA should be able to make greater use of scientific consultants as “Special Government Employees’ to broaden the pool of qualified and approved advisers for the agency.”
Emphasizing his concerns, Eschenbach explained how during his time as Commissioner, he saw “saw firsthand how regenerative medicine offered a cure for kidney and heart failure and other chronic conditions like diabetes. Researchers used stem cells to grow cells and tissues to replace failing organs, eliminating the need for expensive supportive treatments like dialysis and organ transplants.”
Despite these advances, “Breakthroughs for humans were and still are a long way off. They have been stalled by regulatory uncertainty, because the FDA doesn’t have the scientific tools and resources to review complex innovations more expeditiously and pioneer regulatory pathways for state-of-the-art therapies that defy current agency conventions.” As the former FDA Commissioner explained, “Congress has starved the agency of critical funding, limiting its scientists’ ability to keep up with peers in private industry and academia.” As a result, FDA has often lagged “far behind scientific discovery,” which forces the agency “to slow the approval of new treatments—and at times creates acrimonious litigation between the FDA and innovators, not to mention disillusionment among desperate patients.”
Another problem Eschenbach identified is the fact that FDA has no “provisions for continuous education to acquire new skills in emerging fields such as stem-cell biology, nanotechnology or computational biology. Even sending agency staff to academic conferences provoked a congressional outcry over meeting and travel costs.”
Conclusion
In the end, the former FDA Commissioner recognized that Congress must give FDA the resources to be the world’s foremost science-based regulatory agency, “endorse formal career-development programs and encourage more collaboration with scientists in academia, industry, NIH and other federal agencies.
Eschenbach noted that Congress has an opportunity to improve all this as it considers renewing FDA user-fee legislation this year. Ultimately, “at a time when science and technology are creating marvelous medical breakthroughs, the FDA should be leading and guiding the development of state-of-the-art therapies.” Hopefully, Congress will listen to the recommendations and insight from this esteemed for Commissioner, for the benefit of patients and our next generation.