By Pat Anson, Editor
President Trump has nominated a doctor who has proposed radical changes in the regulation of opioid pain medication as the next head of the Food and Drug Administration.
Scott Gottlieb, MD, is a former deputy FDA commissioner and has worked as a consultant to several drug companies. He is currently a fellow at the conservative American Enterprise Institute.
If confirmed by the U.S. Senate as FDA commissioner, The Washington Post reports the 44-year old Gottlieb is “likely to try shaking it up in significant ways,” by speeding up the agency’s approval of new drugs – what President Trump has called a “slow and burdensome” process.
Also of note to pain patients, pharmacists and doctors is that Gottlieb may seek to reduce the role of the U.S. Drug Enforcement Administration in regulating and policing opioid pain medication.
In a column published in The Wall Street Journal in 2012 – which carried the headline -- "The DEA’s War on Pharmacies – and Pain Patients” – Gottlieb wrote that patients would suffer less if medical regulators, not law enforcement agencies, monitored the dispensing and consumption of opioid medication.
“What can be done? We should free the DEA from the dual mandate to be both regulator and cop,” Gottlieb said. “This approach is burdening a lot of innocent patients, including those with legitimate prescriptions who may be profiled at the pharmacy counter and turned away. Others have in effect lost access to care, because their doctors became too wary to prescribe what their patients need. But the DEA tactics aren’t stemming the illegal activity.”
At the time the DEA had just slapped severe penalties on drug wholesaler Cardinal Health for shipping large amounts of opioids to four Florida pharmacies that were essentially operating as pill mills. The backlash from that case led pharmacies across the country to start turning away pain patients with legitimate opioid prescriptions.
“Cardinal has suspended sales to hundreds of pharmacies that it deems ‘suspicious,’ even those in good standing that retain their DEA license to sell narcotics,” wrote Gottlieb. “Pharmacies, in turn, are closely scrutinizing which prescriptions they will fill, making things like baggy pants and a tattoo a liability if you need medicine.”
Calling the DEA the “wrong enforcer” for the job, Gottlieb proposed a radical move: Have the DEA concentrate on street drugs and drug cartels, while the Department of Health and Human Services regulates doctors, pharmacies and others involved in dispensing pain medication.
“Public-health agencies inside the Department of Health and Human Services (HHS) would have more expertise in making the distinctions between illicit diversion and the legitimate practice of medicine. Regulating these activities requires close knowledge of how medical-practice decisions are made, as well as the ability to collaborate with provider groups to enlist them in achieving regulatory goals. Some of the DEA’s resources and mission could be statutorily given to HHS,” Gottlieb wrote.
“A good line of demarcation would be at the point of care. Doctors prescribing narcotics, drug distributors and pharmacies could come under the supervision of HHS. The department would also take responsibility for apportioning active ingredients to manufacturers of narcotics, educating doctors on proper prescribing, and investigating pharmacies and providers who appear to have gone rogue.”
Gottlieb wrote that column five years ago and it is not known if he still holds those beliefs. The current political atmosphere in Washington about opioids may also cool his enthusiasm for stripping the DEA of one of its primary jobs. But it is interesting that he proposed it.
Gottlieb’s ties to the pharmaceutical industry may come under scrutiny during confirmation hearings. Activists are already lining up in opposition to his expected nomination, calling some of Gottlieb's ideas about deregulation “dangerous.”
“Scott Gottlieb is entangled in an unprecedented web of Big Pharma ties. He has spent most of his career dedicated to promoting the financial interests of the pharmaceutical industry and the U.S. Senate must reject him,” said Dr. Michael Carome, Director of Public Citizen’s Health Research Group
“Gottlieb’s appointment would accelerate a decades-long trend in which agency leadership too often makes decisions that are aligned more with the interests of industry than those of patients. The Senate must reject the nomination and demand a nominee who is better suited to protect public health.”