MAUDE Overhaul
Under Gottlieb’s leadership, the FDA also addressed the MAUDE (Manufacturer and User Facility Device Experience) database, which Gottlieb called an incomplete and clumsy system.
He championed a pilot of the National Evaluation System for Health Technology (NEST), calling it a “faster, more real-world post-market adverse event reporting system.” The system has entered into agreements with 12 organizations that represent more than 195 hospitals and almost 4,000 outpatient clinics with access to more than 495 million patient records.
NEST is intended to accept not only reports from patients and caregivers, but also extract medical device problems from such sources as Medicare reimbursement procedure data—a gigantic, rich data mine. In the long run, a portion of higher medical device user fees would help pay for it.
In September, Gottlieb asked Congress for $46 million in fiscal year 2019 to build up NEST and to investigate post-market problems with individual devices.
Interestingly, shortly after announcing his resignation, Kaiser Health News published a blockbuster expose focusing on surgical staplers, entitled, “Hidden FDA Reports Detail Harm Caused By Scores Of Medical Devices.” The story stated the FDA has let medical device companies file thousands of reports of injuries and malfunctions outside MAUDE, leaving doctors in the dark.
The Good and the Bad
While there was some criticism, there was lots of praise about his leadership style.
Ed Silverman of STAT News wrote on March 6, 2019:
“He is chatty to the point of being loquacious. Not just in private, but publicly as well.”
“Anyone who has encountered Gottlieb knows that he is a highly effective communicator and adept at getting out a message, a talent that he honed by regularly penning columns for Forbes and appearing on numerous industry panels before rejoining the FDA in May 2017.”
“He is extremely comfortable with social media and made FDA more relatable and understandable,” said Dr. Josh Sharfstein, a former FDA deputy commissioner and now vice dean for public health practice at Johns Hopkins University. “He jumped into all sorts of topics and spoke his mind on things.”
Last year, for instance he issued 126 commissioner statements, and those followed 36 that were issued in 2017, a year in which he ran the agency for eight months, according to Mark Senak, a senior vice president and partner at the FleishmanHillard public relations firm who writes the Eye on FDA blog.
“I’m confident in saying no other commissioner has issued as many statements as he has,” Senak told me. “But more important, I think he set a new bar for having a commissioner that has a grasp of the issues and was able to artfully and comprehensively weave together so much for the public.”
“The Trump administration just lost its most effective health policy salesman.”
Robert Califf, M.D., Gottlieb’s predecessor as commissioner, said Gottlieb did “a great job” and followed through on Obama administration efforts, such as encouraging the use of “real-world evidence” to augment clinical trials.
Scott Whitaker, the head of AdvaMed, said that during his tenure as FDA commissioner, “Dr. Gottlieb has been a tireless advocate for improved patient care and for promoting innovative solutions to our most pressing health challenges, including greater use of medtech to combat the opioid crises.”
The public advocacy group, Public Citizen, which had described his nomination in 2017 as “entangled in an unprecedented web of Big Pharma ties,” was not quite as generous.
“Not surprisingly, his tenure as commissioner was marked by regulatory decision-making regarding medications and medical devices that tilted further in favor of industry’s financial interests rather than the interests of public health,” said Dr. Michael Carome, director of Public Citizen’s health research group.”
What comes next for Gottlieb and the agency is unclear. He may return to his private work as a venture capitalist and consultant to drug and health-care companies. He was also a resident fellow at the American Enterprise Institute, a conservative think tank that supports deregulation.
