The U.S. Senate has confirmed presidential appointee Dr. Scott Gottlieb as commissioner of the Food and Drug Administration (FDA).
Gottlieb was a resident fellow at the American Enterprise Institute (AEI) until the Senate confirmed him as FDA commissioner by a 57 to 42 vote on May 9. At AEI, Gottlieb focused on FDA, Medicare, Medicaid, and health care reform.
A medical doctor, Gottlieb served as FDA deputy commissioner for medical and scientific affairs under President George W. Bush. He was a senior advisor to the administrator of the Centers for Medicare and Medicaid Services and has served on several pharmaceutical organization boards.
Gottlieb blamed the delayed entry of generic drugs into the market on FDA “lack[ing] the scientific and regulatory framework to efficiently approve copies to complex drugs under its existing rules,” in an op-ed he wrote for Forbes in 2016.
Changes Likely
Dr. John Hunt, a pediatrician, pulmonologist, and coauthor of the free-market High Ground novel series, says Gottlieb will probably try to restore FDA to its lawfully limited role.
“Gottlieb is a vocal free-market advocate who is now in charge of a bureaucracy that stands entirely in opposition [to] the free market,” Hunt said. “Gottlieb seems to be a conservative commissioner who will try to fix FDA, not a libertarian commissioner who would try to eliminate FDA.”
Grace-Marie Turner, president of the Galen Institute, says President Donald Trump and the Senate have given FDA a strong leader.
“I believe that Scott Gottlieb is a superb choice to lead the FDA,” Turner said. “[Gottlieb] is a true leader, and I am delighted that he was asked to serve [and] that he got such a strong vote of confidence from the U.S. Senate in his confirmation hearings.”
Knowledge Is Power
Gottlieb’s prior experience at FDA could enable him to implement swift reforms expanding access to new drugs, Turner says.
“His previous service at the FDA under the George W. Bush administration will allow him to get started immediately with transformative ideas to modernize the agency and accelerate the process of getting new, safe drugs to market to get to faster cures,” Turner said.
Hunt says Gottlieb recognizes patient choice, as opposed to payment methods such as health insurance, as the proper focus of health care policy.
“[Gottlieb] promotes many of the free-market cures and recognizes that health insurance is not synonymous with health care,” Hunt said. “In sum, he gets the diagnosis correct for what ails our sick care system, and his recommended therapies are wise.”
Insider’s Perspective
Gottlieb understands pharmaceutical companies manipulate regulations to shut out competitors, Hunt says.
“[Gottlieb] seems to recognize that FDA is not just a regulator of pharma but is a powerful tool of big pharma, that pharma uses to maintain its monopolies,” Hunt said. “Recognition of this reality is a key part of diagnosing what’s wrong with FDA.”
Turner says as commissioner, Gottlieb will draw from his experience as a health care practitioner and health care policy analyst.
“Not only is [Gottlieb] a practicing physician, but a top-notch policy analyst with deep understanding of the health and pharmaceutical sectors,” Turner said.
Potential Achilles’ Heel?
Hunt says Gottlieb’s close familiarity with FDA and pharmaceutical companies could make him too sympathetic to the establishment.
“Our new FDA commissioner is an insider—inside FDA and inside big pharma—who will try to make FDA work better,” Hunt said. “People who believe that they can make government work better are like enablers of the alcoholic loved one.”
Special-interest groups will try to pressure Gottlieb to preserve the status quo, Hunt said.
“The bureaucrats will manipulate a commissioner who thinks he can fix things, just as an alcoholic will pull on the heartstrings of her codependent,” Hunt said. “The defensiveness and denial of bureaucracy are every bit as strong as the defensiveness and denial of an addict.”
Still, it is reasonable to hope Gottlieb will leave FDA in better shape than he found it, Hunt says.
“Overall, it seems that Gottlieb is an insider conservative with deep knowledge of FDA who likely can mildly improve a terribly flawed organization,” Hunt said. “He will know the limitations in what he can accomplish.”
Hayley Sledge ([email protected]) writes from Springboro, Ohio.
