The FDA Welcomes A New Commissioner: What Will Dr. Gottlieb Do?
Mark Senak contributed to this article.
Dr. Scott Gottlieb, the newly appointed commissioner of the U.S. Food and Drug Administration (FDA), has taken the lead of an agency that regulates one-fifth of the economy and oversees two of Americans’ most important commodities, food and medicine.
As he gets to work, he’ll face a litany of issues which will affect businesses, caregivers, patients and consumers in the U.S. and around the world: implementing the 21st Century Cures Act, approving medicines more quickly while ensuring their safety, combatting opioid abuse, getting generics to the marketplace sooner to reduce prescription drug costs, and securing our nation’s food supply.
A physician by training, Dr. Gottlieb brings an impressive CV to his job that offers a unique blend of expertise. He’s a venture capitalist, an advisor and board member to pharmaceutical and biotechnology companies, an American Enterprise Institute scholar, a prolific writer and speaker, and he is taking his second “tour” of the FDA; he was a deputy commissioner under President George W. Bush. And, as a cancer survivor, he has been not only doctor, but a patient.
Here’s what we’ll be paying close attention to as Dr. Gottlieb takes the reins of this most important federal agency.
Will Dr. Gottlieb oversee a wholesale ‘culture’ change in the way FDA approves new drugs?
In 2012, Dr. Gottlieb wrote an article for National Affairs highlighting the approval of a drug for Hunter Syndrome. Clinical trials took far too long, he wrote, robbing children of a medicine which could help them if only it had been approved sooner. The reason? A “culture of mistrust” driven by the scars of the public-health tragedy created by thalidomide. It led to an FDA “devoted to averting risks and protecting the public,” Dr. Gottlieb wrote. “In so heavily prioritizing one of its obligations — the protection of consumers — the FDA has sometimes subordinated and neglected its other key obligation, which is to guide new medical innovations to market.” He has advocated the FDA concentrate its safety efforts in those areas where the risks are highest and might have the greatest impact.
Shortly after Dr. Gottlieb left the FDA, Congress signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA). It gave FDA a new, powerful tool, known as the “breakthrough therapy” designation, to help drug makers speed the development and review of new drugs with preliminary clinical evidence that indicates the drug may offer a substantial improvement over available therapies for patients with serious or life-threatening diseases. Friends of Cancer Research reports that as of March 30, 2017, FDA has approved 55 breakthrough therapy designated products. That includes 20 new cancer medicines making a huge difference for patients and their families.
That may not be enough to satisfy Dr. Gottlieb. He’s already hit the ground running, announcing in an all-staff meeting on Monday that he is reorganizing the Office of Regulatory Affairs to have workers concentrate on specific areas like drugs and devices so they can increase their expertise in keeping drugs safe.
In sum, there is a lot to watch for. Our next post will be how the FDA will approach combatting opioid abuse under Dr. Gottlieb’s leadership.