On July 15, 2017, FDA Commissioner Scott Gottlieb, M.D., issued a statement regarding the National Academies of Sciences, Engineering, and Medicine (NASEM) report on pain management and prescription opioid abuse. In March 2016, the FDA asked NASEM to outline the state of the science regarding prescription opioid abuse and misuse, as well as the evolving role that opioids play in pain management. The comprehensive report, which included recommendations for the FDA and others, was released on July 15, 2017. Many of NASEM’s recommendations for the FDA were in areas where the FDA had already begun work.
First, the FDA has begun work to ensure drug approval and removal decisions are made within a benefit-risk framework that evaluates not only the outcomes of opioids when used as prescribed, but also the public health effects of the inappropriate use of these drugs. For example, the FDA requested the removal of an opioid product from the market based on concern that the product’s risks associated with its deliberate misuse outweigh its intended benefits when it was used as directed and lead to dangerous unintended consequences.
Second, the FDA has begun work to reduce the rate of new addictions by helping to make sure that only appropriately indicated patients are prescribed opioids, and that the prescriptions are for durations and doses that properly match the clinical reason for which the drug is being prescribed in the first place. To do so, providers must be properly informed about suitable prescribing and the risks and benefits associated with opioid drugs. Dr. Gottlieb announced that the FDA intended to update and modify the existing Risk Evaluation and Mitigation Strategy (REMS) for extended-release/long-acting opioid analgesics, and for the first time, include immediate-release opioid analgesic products in the modified REMS program. The modified REMS will include revisions to the existing FDA blueprint for prescriber education, which describes the content that must be covered in an educational program for it to be considered REMS-compliant. The FDA will also ask, for the first time, that this training be made available to non-physician providers, including nurses and pharmacists. Under the modified REMS, the training will continue to be provided by accredited continuing education providers, but the FDA has proposed that the training include broader information on pain management and enhanced information about the safe use of opioid analgesics, basic elements of addiction medicine, and opioid use disorders. The FDA’s Opioid Policy Steering Committee will continue to evaluate what additional steps are needed to make sure providers are properly informed about the risks and benefits of these drugs. As part of these efforts, the FDA will consider the appropriateness of mandatory education, and how the FDA would operationalize such a requirement.
Third, the FDA has been focusing its efforts on securing the critical data needed to better understand the impact of opioid medications. For example, the FDA gathered independent experts for a scientific workshop to discuss both the existing science and what else is needed to properly assess the impact of opioid formulations with abuse-deterrent properties on misuse, abuse, addiction, overdose, and death. The FDA strongly supports a transition from the current market dominated by conventional opioids to one in which the majority of opioids have meaningful abuse-deterrent properties. At the same time, the agency is encouraging the development of new treatment options for patients in pain, especially treatments that are not addictive. The FDA is also continuously re-evaluating the safety of approved opioid products based on both post-market data the FDA has required from sponsors and additional sources of information as part of safety surveillance.
These are just some of the important efforts the FDA has underway. But to make a meaningful impact, this epidemic must be addressed as a public health emergency, and requires an all-of-the-above approach. As underscored in the NASEM report, the scope of this epidemic is so large, it is going to require a coordinated effort that includes federal, state, and local partners. This complex public health emergency demands the attention and involvement of all parties – including the FDA and other government agencies, health care providers, the medical products industry, policy makers, patients, and patients’ families.
See the FDA Announcement
See also Medical Law Perspectives Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication
See also Medical Law Perspectives Report: Prescription Painkillers: Risks for Patients, Pharmacists, and Physicians
See the Medical Law Perspectives Blog: Risks of Prescription and OTC Pain Medicines During Pregnancy
See the Medical Law Perspectives Blog: Pharmacy Owes Duty To Patient Not To Fill Excessive Prescriptions for Opioids
See the Medical Law Perspectives Blog: New Back Pain Treatment Options Offer Hope, Require Caution
See the Medical Law Perspectives Blog: Opioid Pain Pill Abusers Switch to Heroin; Heroin Overdose Deaths Double