The former Commissioner of the US Food and Drug Administration (FDA), Andrew von Eschenbach, has more than a few ideas about improvements that could be made to the agency he used to lead.
In a series of articles, Eschenbach, now with The Manhattan Institute's Project FDA, has argued on behalf of making some potentially radical changes at the agency.
In a February 2011 Wall Street Journal opinion piece, Eschenbach argued on behalf of a safety-based approval system in which drugs would be given a preliminary approval based on safety before being evaluated for effectiveness at a later date, particularly for drugs with smaller patients populations. What is needed is an "FDA pilot programs to bring promising therapies to patients more quickly to be approved based on safety, with efficacy to be proven in later trials," wrote Eschenbach.
Writing just two months later in The Wall Street Journal, Eschenbach said he believed one of the most fundamental problems facing FDA was something largely no within its control: funding.
"For decades, Congress has starved the agency of critical funding, limiting its scientists' ability to keep up with peers in private industry and academia," Eschenbach wrote. "The result is an agency in which science-based regulation often lags far behind scientific discovery."
More than just reducing FDA's ability to hire new staff, the funding shortages are harming the agency's ability to keep its current staff up-to-date on the most recent trends and advances in science, Eschenbach explained.
Now, writing once again for The Wall Street Journal, the former FDA commissioner claims the agency's medical device policies are causing unnecessary delays and hurting patients.
"American patients used to be the first to benefit from their country's enormous investments in basic medical research," writes Eschenbach. "Today, Americans wait as much as 60% longer than they did in 2005 for new lifesaving and life-enhancing medical devices-such as stents that keep arteries open and defibrillators-to reach the market, according to a recent Government Accountability Office report."
"During that wait, many remain sick or disabled. Some die."
Eschenbach calls for three changes to be made to the agency to speed devices to patients: new approaches to clinical trials with a greater emphasis on computer modeling, more proactive postmarket surveillance for medical devices, and more industry collaboration.
"The consequences of not doing so," Eschenbach writes, "are clear."
"Today the medical-device industry flourishes overseas, even as it struggles under unnecessary regulatory burdens in the U.S. A 2010 study found that European patients gain access to "new U.S.-created medical technologies" more than two years earlier, on average, than American patients."
"The medical-device industry is valuable," Eschenbach concludes. "If the U.S. doesn't want it, someone else will."
WSJ - Von Eschenbach and Hall: FDA Approvals Are a Matter of Life and Death