The newly appointed FDA Commissioner, Robert M. Califf, M.D., has made addressing the opioid crisis a priority. On February 4, as many CADCA members were wrapping up their training at CADCA’s National Leadership Forum, the FDA announced an action plan to reassess the agency’s approach to opioid medications.
On the heels of this sweeping announcement, the FDA set a meeting of its Science Board for March 1. The discussion goals were as follows: discuss the role of opioids in pain management; consider the development of new drugs to treat pain that have reduced risks of being abused; and explore the role that FDA plays as part of a larger Federal, state and local response to the challenges of providing appropriate pain treatment while reducing prescription opioid drug abuse. If you have a little bit of a policy wonk in you, here are some background materials the FDA compiled that you may enjoy reading.
I was an eyewitness to this meeting. One of the great opportunities we have at CADCA is to represent the coalition field at moments in time like this. Not surprisingly, the gathering of medical experts focused most of their attention on pharmacologic solutions. It was stated that the FDA does not regulate the medical community. However, they do have tremendous influence over labeling, new products, abuse deterrent formations and Risk Evaluation and Mitigation Strategy (REMS) which require manufacturers to ensure that the benefits of a drug or biological product outweigh its risks.
The first part of the day was presentations from various high-level speakers about policy, pain, addiction, and data. In the afternoon, there was time allotted for public comment. For more than an hour and half, the science board and FDA leaders heard from a wide array of U.S. citizens and, oddly enough, one Frenchman. Most poignant to me was the statement by Don Flattery, a father who lost his 27 year-old son to the disease of addiction, and pointed to his son’s early exposure to opioids as a result of a sports injury. The Board heard from a patient advocate with a rare connective tissue disorder who stressed the need for access to opioids in order to aid in her daily functioning. Comments were heard from industry representatives, passionate advocates (both on the pain and addiction sides of the issue), and even a manufacturer of a medical device promising to safely distribute opioid doses. The public comment period represented a very diverse group of ideas and underscored the complexity of the problems we face.
In DC it is rare to see a U.S. Senator off Capitol Hill. So I was excited to see that Sen. Joe Manchin of West Virginia made the trip across town to share a statement during the public comment time as well.
Every day, 44 people in the U.S. die from overdose of prescription opiates. Local CADCA advocates have been acting, not waiting. Coalitions are educating youth and parents about the risks, engaging prescribers about their practices, supporting PDMPs, hosting take back days with law enforcement, working in schools to provide medicine safety education and much more. Some of the challenges have to be met at the state and Federal levels. The FDA has both the authority and the relationships to make a monumental impact. CADCA is committed to tracking all the federal actions related to our opioid crisis, and keeping the field up-to-date.