New FDA Chief Appoints Panel to Help Fight Opioid Epidemic


 

The newly appointed head of the FDA is following through on his commitment to combat the growing opioid abuse epidemic.

Food and Drug Administration Commissioner Scott Gottlieb May 23 announced he is establishing an opioid steering committee to explore and develop tools the agency can use to combat the epidemic. In April, at his confirmation hearing, Gottlieb told the Senate Health, Education, Labor, and Pensions Committee that the opioid epidemic would be his highest priority.

The steering committee’s first actions will be to address three questions, including whether the FDA should require some form of mandatory education for health-care professionals who prescribe opioids; whether the agency should take additional steps under its risk management authorities on opioid prescribing; and whether the FDA is using the proper policy framework to consider the risk of abuse and misuse as part of the drug review process for opioids.

“Despite the efforts of FDA and many other public health agencies, the scope of the epidemic continues to grow, and the human and economic costs are staggering,” Gottlieb said. “Working together, we need to do all we can to get ahead of this crisis. That’s why we’ll also be soliciting public input, through various forums, on what additional steps FDA should consider.”

The biopharmaceutical industry wants to help Gottlieb with his efforts.

Jim Greenwood, president and chief executive officer of the Biotechnology Innovation Organization (BIO), said in a statement “America’s biopharmaceutical companies are committed to finding solutions to help curb opioid abuse.”

“Several of our member companies are developing non-addictive, next generation therapies with the potential to transform the standard of care for pain management,” Greenwood said. “They are also working to develop new opioid formulations that prevent or deter improper use, such as tamper-proof pills, and taking steps to increase their prescriber education efforts.”

Greenwood said BIO will work with Gottlieb and the committee “to better meet the needs of patients with chronic and acute pain.”

Read my full article here.

Stay on top of new developments in health law and regulation with a free trial to the Health Law Resource Center.

Learn more about Bloomberg Law and sign up for a free trial.