We support policies that promote cautious, evidence-based prescribing of opioids and other controlled drugs.
PROP comments on the draft National Pain Strategy
Last May, PROP submitted a comment to the National Institutes of Health on its proposed National Pain Strategy. We objected to the proposal for a so-called “safe use campaign” for opioid prescribing and instead called for an educational campaign that discourages opioid use for conditions where risks are likely to outweigh benefits.
PROP’s position on Federal Bills
Bipartisan legislation introduced by Senator Joe Manchin (D-WVa) on April 15, 2015. Co-sponsors include Tim Kaine (D-Va), David Vitter (R-LA) and Shelley Moore Capito (R-WVa). The bill requires the FDA to establish an advisory panel for each application submitted to the FDA for approval of an opioid drug and report to congress any instance where approval is recommended when inconsistent with the advice of the panel. A drug approved inconsistent with the recommendations of the advisory panel shall not be introduced or delivered for introduction into interstate commerce until the report describing the approval has been submitted to Congress.
Bipartisan legislation introduced on July 30, 2015, by Senator Pat Toomey (R-PA) with co-sponsors Joe Manchin (D-WVa), Tim Kaine (D-VA), Sherrod Brown (D-OH), Rob Portman (R-OH). This bill would authorize the use of patient review and restriction (PRR) programs in Medicare, which can help prevent prescription drug abuse among beneficiaries. The use of PRR programs will assign patients who are at-risk for opioid dependence to predesignated pharmacies and prescribers to better manage appropriate care and monitor prescriptions of opioid drugs for Medicare beneficiaries.
The bill would limit the DEA from suspending the registrations of entities that pose an “imminent danger to the public health or safety.” This bill was lobbied for by corporations that distribute and sell opioid analgesics. We are opposed because it limits the authority of the DEA to suspend the registration of DEA registrants (manufacturers, wholesalers, retailers, pain clinics) who may be putting the public at risk.
This bill is bipartisan legislation introduced by U.S. Senators Edward Markey (D-Mass) and Rand Paul (R-Ky) on May 22, 2015, which will expand treatment for those suffering from prescription drug and heroin addiction. A companion bill was introduced in the House of Representatives by Representatives Brian Higgins (D-N.Y.), Richard Hanna (R-N.Y.), Paul Tonko (D-N.Y.), and John Katko (R-N.Y.). The legislation would expand the ability of addiction medical specialists and other trained medical professionals to provide life-saving medication-assisted therapies such as buprenorphine for patients battling opiate addiction. The bill will raise the limits on the number of patients a physician or nurse practitioner may treat from 30 to 100 in the first year and with no limit thereafter. Those providing treatment must receive additional training in addiction, use the Prescription Drug Monitoring Program (PDMP) and administer treatment in a qualified practice setting with defined oversight.
This legislation was re-introduced on February 15, 2015, by U.S. Senators Sheldon Whitehouse (D-RI) and Rob Portman (R-OH) and was co-sponsored by 13 additional Senators. A House of Representatives companion bill, HR 953 has also been introduced. This legislation will expand prevention and education efforts, expand access to the overdose-reversing drug Naloxone, support alternative treatment in lieu of incarceration, strengthen the Prescription Drug Monitoring Program and support expansion of the use of evidence-based treatment medications. CARA 2015 designates up to $80 million toward these efforts.
Bipartisan legislation introduced on June 23, 2015, by Senators Harry Reid (D-NV) and Dick Durbin (D-IL) with co-sponsors Leahy (D-VT), Markey (D-MA) and Whitehouse (D-RI). Companion bill offered in the House by Representative Edwards (D-MD), Carney (D-DE) and others. This bill amends the PHS Act to require SAMHSA to enter into cooperative agreements to purchase and distribute naloxone and to distribute education materials to the public, first responders, and health professionals on overdose prevention and response.
Bipartisan legislation introduced on March 11, 2015, sponsored by Senator Ed Markey (D-MA) with co-sponsors Kelly Ayotte (R-NH), Tim Kaine (D-VA) and Pat Toomey (R-PA). The bill limits civil liability for health care professionals who prescribe or provide naloxone and to trained laypersons who administer it in an overdose event. Companion bill introduced in the House by Representatives Neal (D-MA), Guinta (R-NH) and Comstock (R-VA).
Bipartisan legislation introduced on March 19, 2015, by Senator Mitch McConnell (R-KY) and Casey (D-PA) with co-sponsors Kelly Ayotte (R-NH), Rob Portman (R-OH) and others. Companion bill introduced in the House by Representative Clark (D-MA) with 72 co-sponsors. This bill requires the Agency for Healthcare Research and Quality to report on prenatal opioid abuse and neonatal abstinence syndrome (symptoms of withdrawal in a newborn). The report must include an assessment of existing research on neonatal abstinence syndrome, an evaluation of the causes, and barriers to treatment, an evaluation of treatment for pregnant women with opioid use disorders and infants with neonatal abstinence syndrome, and recommendations on preventing, identifying, and treating opioid dependency in women and neonatal abstinence syndrome. HHS is directed to develop a strategy to address gaps in research and programs and the CDC must provide technical assistance to states to improve neonatal abstinence syndrome surveillance and make surveillance data publicly available.