FDA's Science Board to Discuss Opioid Abuse

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By Bronwyn Mixter

Feb. 17 — The FDA's Science Board will hold a public meeting on March 1 to discuss, among other things, the role that the agency plays in providing appropriate pain treatment while reducing opioid abuse.

The meeting comes as congressional and state leaders have taken actions to address the U.S. opioid abuse epidemic. President Barack Obama also has asked Congress for $1.1 billion in his fiscal year 2017 budget to combat the epidemic, a crisis so severe that it has in part led a handful of senators to block his nominee to run the Food and Drug Administration .

The meeting will be held on March 1 from 8:30 a.m. to 5 p.m. at the FDA's White Oak Campus in Silver Spring, Md. A notice announcing the meeting was published Feb. 17 in the Federal Register (81 Fed. Reg 8,078).

The FDA said the topics for discussion will include:

  •  the role of opioids in pain management,
  •  scientific challenges facing the FDA in supporting the development of pain medications, including opioids, that have reduced risks of being abused;
  •  scientific challenges facing the FDA in seeking to understand the real-world use of opioids to treat pain, including the impact of opioids with potentially less risk for abuse;
  •  the role that the FDA plays as a part of a larger federal, state and local response to the challenges of providing appropriate pain treatment while reducing opioid abuse; and
  •  postmarket surveillance activities related to opioids.
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    The agency also said the Science Board will receive a final report from the Centers of Excellence in Regulatory Science and Innovation Program Evaluation Subcommittee.

    The Science Board provides advice to the FDA on complex scientific and technical issues important to the agency and its mission, including emerging issues within the scientific community.

    House, Senate Actions

    Democratic lawmakers, including Sens. Edward Markey (Mass.) and Joe Manchin III (W.Va.), have said they will oppose Robert Califf's nomination to lead the FDA because they think the agency's oversight of opioid painkillers isn't strong enough. The lawmakers said they want the agency to reverse its approval of a pediatric use for OxyContin . Sen. Kelly Ayotte (R-N.H.) recently joined Markey in placing a hold on Califf's nomination because of the agency's approval of OxyContin for kids.

    However, the Califf nomination is expected to proceed, with a Feb. 22 cloture vote scheduled.

    Several House and Senate bills also have been introduced to deal with the opioid abuse epidemic. Most recently, Manchin introduced a bill (S. 2543) Feb. 11 to amend the FDA's mission statement to say that the agency is “also responsible for protecting the public health by strongly considering the danger of addiction and overdose death associated with prescription opioid medications when approving these medications and when regulating the manufacturing, marketing, and distribution of opioid medications.”

    State Actions, Super Bowl Ad

    Vermont Gov. Peter Shumlin (D) Feb. 11 also sent a letter to drug manufacturers AstraZeneca and Daiichi Sankyo, asking them to pull an advertisement that first aired during the Super Bowl for Movantik (naloxegol), a drug that treats opioid-induced constipation.

    “The irrational exuberance with which opiates are handed out in America is driving the addiction crisis in this country,” Shumlin said. “Now is the time to change that, not attempt to further normalize long-term opiate use by advertising a drug to help people take even more opiates during the most watched sporting event of the year.”

    Shumlin asked the companies to immediately pull the advertisement and other advertisements promoting Movantik and “instead use the money to fund opiate and heroin prevention efforts.”

    To contact the reporter on this story: Bronwyn Mixter in Washington at bmixter@bna.com

    To contact the editor responsible for this story: Brian Broderick at bbroderick@bna.com

    For More Information

    The Federal Register notice is at https://www.gpo.gov/fdsys/pkg/FR-2016-02-17/pdf/2016-03152.pdf.

    The governor's letter is at http://governor.vermont.gov/node/2623.