Congressman Rogers Questions FDA & Coast Guard about Efforts to Combat the Nation's Opioid Abuse Epidemic
Apr 17 2018
WASHINGTON, DC -- During budget hearings on Capitol Hill today, U.S. Rep. Harold "Hal" Rogers (KY-05), who serves as Chairman Emeritus of the House Appropriations Committee, brought the nation's opioid abuse epidemic to the forefront of discussions with Admiral Paul F. Zukunft, Commandant of the U.S. Coast Guard and Dr. Scott Gottlieb, Commissioner of the Food and Drug Administration (FDA).
"We are continuing to see the problem grow worse. Overdose deaths are approaching 60,000 each year. You've increased seizures and interdictions by a great amount. It's astounding. In 2017, you interdicted 223 metric tons of cocaine, more than $6 billion worth from 708 suspected smugglers. It's great work," said Chairman Rogers to Admiral Zukunft. "Columbia is a great friend of the U.S., but they have stopped eradicating the poppy and we're being flooded. It's killing people by the tens of thousands. I salute you on the seizures you are making, but it's not quite enough."
Later in the afternoon, Chairman Rogers applauded Dr. Gottlieb for taking great strides to impact the drug abuse crisis through the FDA's regulatory authority. Since becoming the FDA Commissioner nearly one year ago, Dr. Gottlieb has taken the following actions: he formed an Opioid Policy Steering Committee to examine mandatory pain management education for healthcare professionals; removed Opana Extended Release (ER) from the market after postmarketing data showed significant potential for abuse and misuse; implemented a Risk Evaluation and Mitigation Strategy (REMS) plan for prescribing immediate release opioids for the first time to weigh the risks of overdose and abuse; approved a small electrical nerve stimulating device to help reduce the symptoms of opioid withdrawal; issued guidance to encourage the development of generic abuse-deterrent formulations of opioids; and he joined the Federal Trade Commission to release a joint warning letter to marketers and distributors of 12 opioid cessation products for illegally marketing unapproved products.
"Upwards of 50 percent of people who become addicted, their first exposure will be from a lawful prescription. So, people are still becoming addicted from a prescription, although more and more people, their first exposure is increasingly a street drug, which is a low-cost alternative. What we want to do is put in place more measures that could help rationalize prescribing and make sure that when pills are dispensed, it's for an appropriate duration," explained Dr. Gottlieb. "So, the idea is that we would build in place evidence-based guidelines perhaps in labeling and perhaps by providers in health systems to better adjust what gets dispensed. We are working through that right now."
"The miracle drug hopefully that comes along is an effective pain management pill that is not addictive," said Congressman Rogers to Dr. Gottlieb. "NIH and CDC are working heavily to make that happen. Have you any thoughts on that?"
"When it comes to chronic administration of any drug for the treatment of pain, there has been no free lunch," said Dr. Gottlieb. "All the drugs have had some liability associated with them whether they are safety issues with chronic administration, abuse potential; so, we would need to look at this very carefully, but we do see some promise in the early pipeline."
To watch the hearing with the U.S. Coast Guard, click here.
To watch the hearing with the FDA, click here.
Chairman Rogers questions federal leaders about ongoing efforts to combat the drug abuse epidemic