Gottlieb Helps FDA Reassert Regulatory Influence

FDA Commissioner Scott Gottlieb, MD

FDA Commissioner Scott Gottlieb, MD

It’s now more than 400 days into his tenure as Commissioner of the U.S. Food and Drug Administration (FDA), and Scott Gottlieb has revitalized the agency and put it “back on top,” said Nancy Myers, president and founder of Catalyst Healthcare Consulting.

Gottlieb was applauded by all the members of a panel who discussed “Analyzing Innovations Progress in the Gottlieb Era” at the DIA 2018 conference in Boston today (June 25).

Last year was a good year for the FDA, echoed Sandra Milligan, senior vice president and head of global regulatory affairs and clinical safety at Merck Research Laboratories. Gottlieb has been able to bring in new employees and skillfully worked the appropriations process to acquire more funding for the agency, she said.

Gottlieb has also done an excellent job promoting transparency and increasing the flow of information coming out of the agency. “There’s a new openness to bringing in more points of view…and input from sponsors,” Milligan says.

Under Gottlieb, the FDA has “changed the paradigm” by doing its part to reduce review times and otherwise promote rapid development of drugs, Milligan says. That offers the promise of shortened review times, she adds.

Citing a specific example, Milligan praised Gottlieb and team for its recent creation of the Oncology Center of Excellence (OCE), which leverages the combined skills of regulatory scientists and reviewers with expertise in drugs, biologics, and devices (including diagnostics). It’s designed help expedite the development of oncology and hematology medical products and support an integrated approach in the clinical evaluation of drugs, biologics, and devices for the treatment of cancer. The OCE works with centers and offices across the FDA.

The FDA is also working hard to be thoughtful during the pre-certification process, says Kathy Hibbs, chief legal and regulatory officer at 23andMe. Specifically, the agency is increasingly looking beyond indications and taking into account broader classifications. FDA’s shift “should be celebrated,” Hibbs says.

Gottlieb is also helping to inspire venture capitalists and others to invest more capital into pharmaceutical industry, says Doug Cole, managing partner at Flagship Pioneering. Gottlieb has sent a “very positive message” to investors by, among other things, helping to remove some of the mystery around regulation. “The agency is moving to provide clarity in regulatory paths,” Cole says.

Investors don’t like uncertainty, Cole adds. They’d rather know a bad truth than be ignorant and hope for the best, he says. Gottlieb’s steady stream of communication is providing financiers with a greater sense of certainty from regulators, which “gives people a sense of what it will take” to develop a drug or device, he notes.

Author: Michael Causey