Groundhog Day is happening today to bring us the valuable insight related to the length of winter and the beginning of Spring. Exciting, but not as thrilling in my mind as the re-establishment of Daylight Saving Time when the hours of daylight will linger later, to occur in just about six weeks. As we await both events, here is a bit of what went on this week that is of note:
- Opioid Crisis Actions – While holding a meeting of the Opioid Policy Steering Committee this week, FDA Commissioner Gottlieb announced an additional step and sent a signal on future direction regarding FDA actions to address the crisis. First, the signal – several times the Commissioner has expressed the goal of having opioid prescriptions that conform to the clinical need and in his communication provided more specifics on how to get there whereby immediate release opioid drugs might be packaged in three or six-day blister packs for short term use in the case, for example, of addressing dental procedure pain. His statement did not outline the pathway to achieving this goal, but clearly there is momentum to limit prescriptions of opioids. And the step taken this week was with respect to OTC loperamide which can be misused in high doses, but safe at recommended doses, requesting changes be made in the label and number packaged for the product. But most specifically the action seemed aimed at online retailers who may sell the product in bulk. The announcement was another in a long line of individual actions taken to address opioid addiction from FDA. No word on how large a problem OTC loperamide is in the context of the greater issue of opioids.
- Presidential Backing on Right to Try – Among other things in the State of the Union address was an endorsement by Trump of legislation popularly known as “Right to Try”. Passed in the Senate the bill, which would prohibit the Federal government from interfering with state laws allowing patients to access medicines prior to their full testing and approval by FDA, has hit snags in the House. Gaining access to life-saving drugs sooner has long been a goal for patients facing life-threatening illnesses and the HIV/AIDS epidemic served as a catalyst for faster approvals and earlier access. It is not a black and white proposition, there do already exist pathways for early access for patients, and FDA Commissioner Gottlieb has noted in testimony that FDA has approved 99 percent of the applications for such access that the agency has received. For a viewpoint from former AIDS activists and a former FDA CommissionerRight to Try may not be a great idea, check out this op-ed from June 2015.
Upcoming Events to Keep an Eye on This Week
- Senate HELP Committee, Full Committee Hearing – The Opioid Crisis: Impact on Children and Families – February 8, 2018