The FDA is establishing a steering committee to explore and develop tools the agency can use to combat the growing opioid abuse epidemic.
Food and Drug Administration Commissioner Scott Gottlieb May 23 announced he is establishing the committee.
Its 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. Deaths involving prescription opioids have quadrupled since 1999, and in 2015 opioids were involved in the deaths of 33,091 people in the U.S.
“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,” Gottlieb said.
Several lawmakers also said they were concerned about the opioid epidemic and praised Gottlieb for establishing the committee.
Sen. Lamar Alexander (R-Tenn.) said in a May 23 statement “in his confirmation hearing, Dr. Gottlieb told me he wanted to be confirmed to lead the FDA so he could take on this public health crisis, and I know there are senators on both sides of the aisle in our Senate health committee and many in the United States Senate who will support his efforts.” Alexander is the chairman of the Senate Health, Education, Labor, and Pensions Committee.
In addition, Sen. Shelley Moore Capito (R-W.Va.) said in a statement that establishing the committee “is a good first step in making sure FDA is a key player in efforts to reduce widespread addiction, and I look forward to continuing to work with the commissioner and others to combat this crisis and narrow its scope.”
Other senators also have questioned the Centers for Medicare & Medicaid Services on opioids.
A coalition of five Democratic senators and one independent May 17 sent a letter to the CMS asking for details on how the agency monitors opioid prescribing.
The senators wanted to know whether the agency had identified any trends, red flags, or outliers of opioid overprescribing. Companion letters were sent to the Drug Enforcement Administration and commercial insurers.
Blair Childs, senior vice president of public affairs at Premier Inc., said in a May 24 statement that Gottlieb’s action “is an important first step in the battle against opioid misuse, pain management and addiction.” Premier is a group purchasing organization.
“We strongly support the FDA’s consideration of mandatory education for healthcare professionals on pain management, addiction and treatment. We believe these treatment practices and measures need further testing in real-world settings to ensure professionals are trained based on what the evidence has proven to work,” Childs said. “This requires the FDA to take advantage of existing data sources and registry platforms to monitor opioid use and measure the impact of implementing best practices.
Childs said Premier also encourages “the FDA to ensure these approaches involve the patient as partners in their care to promote mutual understanding and expectations, increase compliance and decrease misuse.”
The Alliance for Balanced Pain Management (AfBPM) hopes the steering committee “will not only focus on prevention and curbing abuse, which is very important, but also on access to a more balanced pain management approach and subsequent public health policies that can lead to more relief for pain patients while helping to curb the abuse of opioids,” Brian Kennedy, who serves on the AfBPM’s steering committee, said in a statement. The AfBPM is a collective of 24 health-care advocacy groups, patient organizations, industry representatives, and other stakeholders who advocate for balanced pain management.
Kennedy said “a one-size-fits-all pain care model has helped lead to the opioid addiction crisis our country faces. Often, patients dealing with pain are prescribed opioids because other modalities of pain care like physical therapy or cognitive therapy are not covered by insurance.”
Jim Greenwood, president and chief executive officer of the Biotechnology Innovation Organization (BIO), said in a May 24 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.”
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Gottlieb's announcement is at http://src.bna.com/pbU.
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