Opioid Painkller Abuse Subject of FDA Science Advisory Committee Hearing

A panel of experts will hold a public hearing next month to discuss the role the government can play in reducing abuse of opioid painkillers, while also offering appropriate pain management for those who need it. 

The FDA issued a Federal Register notice on February 17, announcing that its Science Advisory Board will convene on March 1 to discuss the growing epidemic of narcotic painkiller abuse in the United States.

The meeting comes after the U.S. Centers for Disease Control and Prevention (CDC) reported in December that drug overdose deaths have reached an all-time high in the U.S., increasing 137% since 2000. Overdoses involving prescription opioid painkillers, such as Vicodin and OxyContin, have reached record levels. In 2014, more than 60% of overdose deaths involved some type of narcotic painkiller.

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The hearing will focus on topics including the scientific challenges the FDA faces to support the development of pain medications that have a decreased risk of abuse, understanding the real world use of opioids to treat pain, the role the FDA plays as a larger response to offering pain treatment while reducing abuse, and post market surveillance for opioids.

The Science Board provides advice to the FDA on scientific and technical issues important to the agency, including emerging issues within the scientific community. While the board’s recommendations are not binding, the FDA often factors its findings heavily in its final decision-making.

Opioid Abuse Raises Congressional Concerns

The opioid abuse epidemic in this country have led several U.S. Senators to try to block the nomination of Dr. Robert Califf to replace Margaret Hamburg as the FDA commissioner, indicating that they will oppose Califf’s nomination because they think the agency’s oversight of opioid painkillers is not strong enough.

The senators are focusing on the agency’s approval of pediatric use for OxyContin, and want the approval to be reversed. The senators have said they fear the decision could create a younger demographic of opioid addiction.

A study published last year in the journal Pediatrics concluded that teens prescribed opioids may have a higher chance of abusing opioids, compared to teens who don’t receive these medications at a young age. A narcotic painkiller prescription before high school graduation showed a 33% increase in the risk of future opioids misuse and abuse.

The Califf nomination is still expected to proceed, with a vote scheduled for Feb. 22.

President Obama recently asked Congress for $1.1 billion in the 2017 fiscal year budget to combat the growing narcotic painkiller epidemic.

The Scientific Board hearing will be held at the FDA’s White Oak campus is Silver Spring, Maryland.


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