With deaths rising each year, there is no question of the urgency that something needs to be done to address the opioid misuse epidemic in the United States. And in addition to mortality there are the lives touched by these deaths, splintering relationships and families, incurring enormous personal and financial cost.
During his confirmation hearings, the opioid issue was a primary concern expressed among policy makers and Commissioner Gottlieb provided reassurance that it for him a top priority. The Strategic Policy Roadmap released by FDA in January has as its first stated area of concentration to reduce the burden of addiction crises.
What the Strategic Policy Roadmap Lays Out and What It Might Mean- Addiction is naturally broader than the opioid epidemic, including nicotine addiction as well. The Roadmap begins by addressing opioids but also addresses nicotine related goals. Below are key principles derived from the document issued by FDA followed by notes on what has already been done by the agency under each category as well as thoughts about what might be expected.
- People are inappropriately prescribed opioid drugs
- Early last year, FDA issued warnings about use of codiene and tramadol in children and nursing mothers and in 2018 acted to revise labeling regarding use of cough medicines containing codeine or hydrocodone in persons under age 18;
- Also this past year, FDA made revisions to the FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics;
- Look for ways to carve out specific circumstances whereby other types of pain relief be first attempted prior to introducing opioids;
- Look for possible additional modifications to the FDA Blueprint;
- Look for focused attention on facilitating non-opioid pain options.
- Durations of prescriptions are often out of sync with need
- In a special statement issued this month regarding OTC loperamide, Dr. Gottlieb discussed the use of blister packs to limit exposure in an OTC product and it is not unlikely that such packaging – and limited courses of treatment – be examined for…