By Yili Huang, DO
The FDA proposed tighter restrictions on opioid manufacturers to identify potential harms and risks. But many questions still need to be answered.
Despite efforts to curb the opioid epidemic, it remains a devastating issue. The Centers for Disease Control says more than 700,000 people died from a drug overdose from 1999-2017 and nearly 130 Americans die each day from an opioid overdose.
Meaningful change is needed. And the Federal Drug Administration may have taken a significant step in the right direction last week when it proposed tighter rules on opioid manufacturers. The proposal puts pressure on manufacturers to identify any characteristics that would mitigate the risks of overdose, abuse or development of addiction. It also offers guidance on the FDA’s benefit-risk assessment framework and details how it will compare the effectiveness and safety of new drugs with existing drugs on the market.
The FDA’s proposal has some positive aspects but more needs to be hashed out.
Risk of addiction and overdose: In the draft, the FDA declares that companies should indicate whether their drugs have novel or greater risks than others on the market, and provide the potential public health implications of their products in terms of risks to non-patients, including members of the patient’s household, visiting relatives, friends and others.
This leads to numerous questions: How could the risk be measured? By potency? Abuse deterrent formulations? The route of administration? What about opioids with multiple mechanisms of action that can potentially affect efficacy, but also affect safety profile/adverse events such as those that exist in Tapentadol or Tramadol? These work on additional neurotransmitters in addition to opioid receptors to treat pain but can themselves cause unique adverse effects.
Ongoing evaluation: The FDA says its benefit-risk evaluation isn’t completed when a product is approved, instead it continuously reevaluates the safety of approved opioid products based on post-market data required from companies. The proposal, however, doesn’t mention existing medications that have been and already impacted the market, which is problematic.
If such risk profiles are to be applied to new medications, current opioids such as Oxycontin (Purdue) and Duralgesic patches (Johnson&Johnson) should be scrutinized too. After all, these medications have affected countless patients leading to lawsuits involving several states.
Be careful: Opioids have presented a unique challenge to health care providers. They have great benefits if prescribed to rightful people who endure legitimate pain, but they can pose significant harm if they are misused or abused.
While tighter rules may be necessary, we should not minimize the many benefits associated with opioids because of potential risks. Statements from drug companies regarding risks should be pre-empted by a disclaimer of benefits in cases such as treatment of acute (postoperative/trauma) pain, pain associated with ongoing cancer, palliative care and hospice, as well as in cases of alternative drug shortages.
Companies should not be de-incentivized to pursue development of medications that treat pain. They should be incentivized to develop safer pain medications.
Patients should always have the right to choose the path of their own health care and our role as health care providers is to educate and inform. If implemented correctly, this new proposal has a chance of accomplishing just that.
Yili Huang, MD, is a licensed and board-certified pain management anesthesiologist and the founder and director of Phelps Hospital’s Pain Management Center. He is also an assistant professor of anesthesiology at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell.