Soon-to-be FDA commissioner, Scott Gottlieb, MD, is well positioned to understand where the medtech and biotech communities are coming from. He’s been a partner at the venture capital fund New Enterprise Associates since he left the FDA in 2007, where he served as deputy FDA commissioner under President George W. Bush, and performed a stint as senior advisor to the commissioner for medical technology.
Dr. Gottlieb has some strong ideas about how the agency should function, some of which he expressed last week in his confirmation hearings, but others he’s made known over the past year or so. Essentially, he thinks the FDA needs to make the approval process for drugs and devices less onerous.
Where He’s Coming From
“Dr. Gottlieb’s unique expertise straddles the intersection of medical care, entrepreneurship, and the role of public policy in facilitating the discovery and development of safe and effective new medical products to patients,” says David Mott, general partner and head of New Enterprise Associates’ healthcare investing practice. “He believes in the power of innovation to improve the quality of patient care and has the insight and experience to make it possible.”
Dr. Gottlieb’s “guidance has proven invaluable to our entrepreneurs and executives,” Mott says. “He understands how transformative innovation occurs – not just the development of new medical treatments, but also the central role that patients and medical professionals, entrepreneurs, investors, and capital markets all play in the life science innovation ecosystem.”
Earlier in his career, Dr. Gottlieb worked as a healthcare analyst for the investment bank Alex. Brown & Sons.
Dr. Gottlieb is a hospitalist trained at Mount Sinai School of Medicine and has been a clinical assistant professor at New York University School of Medicine. He is also a senior fellow at the conservative American Enterprise Institute, where his blog posts and Wall Street Journal editorials provide insight into how he’d run the FDA.
For example, Dr. Gottlieb has talked about changing the FDA’s clinical trial protocol. At his Senate confirmation hearing last week, as reported by MedPage Today, he said, “I have articulated a point of view that with more modern clinical trial design, we could compress Phase II and Phase III trials into one big adaptive design.”
Unshackle Apps, Unveil Rejections
For developers of iPhone and smartphone apps, there may be hope that Dr. Gottlieb would unshackle them from FDA regulation. In a Forbes commentary last year, he said, “Right now, FDA is often too easily distracted by attractive areas like iPhone apps that nonetheless pose relatively low risks and could be ably addressed by other regulatory agencies,” he said.
A couple of other ways Gottlieb may change FDA review of drugs, as reported by STAT:
- When the FDA rejects a drug, he wants to tell the applicants why.
- He would give terminally ill patients access to experimental drugs that have not yet received full FDA approval.
He also wrote in Forbes last year that the agency should speed up and streamline the approval process for generics.
Key FDA constituencies have welcomed Dr. Gottlieb’s nomination. Says Steven J. Ubl, president and CEO of the Pharmaceutical Researchers and Manufacturers of America (PhRMA): “His extensive experience as a physician and breadth of health care knowledge will help ensure the FDA continues to play a vital role in protecting public health and innovation in the agency’s review and approval of new medicines for patients in need.”