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December 21, 2017

PhRMA Releases New Policy Proposals

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On December 11, 2017, the Pharmaceutical Research and Manufacturers of America (PhRMA) issued statements of support for several policy proposals focused on resolving the opioid crisis. The proposals included: limits on prescribing, a ban on prescribing of Schedule II opioids in an office setting, ongoing prescriber training, and expanded access to addiction treatment options.

Along with the policy proposals came an announcement that PhRMA and the Addiction Policy Forum have entered into a multi-year, multi-million dollar initiative to combat the opioid crisis and implement the Forum's plan to help solve the opioid crisis.

PhRMA and Addiction Policy Forum Partnership

The plan identified eight strategic focus areas to address addiction and the recommendations included analysis of key states to identify gaps in existing programs, increased education efforts for patients and families and the development of an online portal to connect individuals with addiction treatment options and information.

“We are deeply committed to addressing the opioid crisis and advancing solutions that will make a meaningful difference for families and communities,” said PhRMA President and CEO Stephen J. Ubl. “This is only possible if we make a point to listen, partner with organizations and experts on the ground, and ensure that our top priority is saving lives. The Addiction Policy Forum is actively working to provide resources to reduce the stigma surrounding addiction and treatment, and we are proud to support their efforts through this new partnership.”

“The challenge in front of us requires that everyone be at the table, working together to implement comprehensive, long-lasting solutions that will save lives,” said Jessica Hulsey Nickel, President and CEO of the Addiction Policy Forum. “We look forward to partnering with leaders in the biopharmaceutical community to help states, cities, towns and families change the trajectory of this crisis.”

Policy Proposals

Prescriber Requirements and Limitations

PhRMA recommends seven-day prescription limits on opioids for acute pain except for “certain conditions or patients, such as chronic pain, pain associated with cancer diagnosis or treatment, palliative care, hospice or end-of-life care, residents of long-term care or nursing facilities and individuals receiving medication assisted treatments for addiction” or when a medical professional determines that the condition causing the acute pain warrants more than the initial supply.

PhRMA also supports a 30-day supply limit for opioids for chronic pain so long as they are coupled with efforts to encourage appropriate use. PhRMA suggests regular checking of prescription drug monitoring programs (PDMPs), regular reassessments of the patient's treatment plan, development of guidelines to inform appropriate treatment of pain, and use of patient treatment agreements to ensure communication between patients and providers.

PhRMA also wants to prohibit dispensing Schedule II medications in an office setting. This would include prescriptions such as methadone, oxycodone, fentanyl, and hydrocodone.

Ongoing Prescriber Education

PhRMA echoes recommendations by experts and regulators, including FDA, that more training and educational tools are needed to help physicians and prescribers responsibly prescribe opioids. The group says mandatory training should be provided for pain management, risks and benefits of prescription opioids, screening for mental health, new pain treatment alternatives and PDMPs.

But PhRMA takes the calls one step further, by arguing licensure should be contingent on ongoing opioid training. “Ongoing training should be a requirement for prescribers seeking either a Drug Enforcement Administration (DEA) license or license renewal to prescribe controlled substances or a state license from an entity such as a Board of Pharmacy.”

Expand Coverage and Access to Addiction Treatments

PhRMA supports expediting review and encouraging development of non-opioid pain medications; ADFs; and medications to treat opioid use disorder, addiction and overdose. The recommendation falls in line with FDA's push for development of new, non-opioid pain medications as well as ADFs and medication-assisted treatment (MAT).

In October, Gottlieb told lawmakers at a House Energy & Commerce Committee hearing that FDA is looking at research that could support a label indication for MAT and provide direction for potential long-term use by patients suffering from addiction.

The agency has also discussed efforts to encourage development of generic ADFs, including by publishing final guidance in November outlining how the agency will evaluate generic ADF oral opioids.

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