Most, but not all, companies manufacturing the involved analgesics had joined together in an Industry Working Group (IWG) to wrestle with the problems of reducing abuse of the drugs while still maintaining access for patients who thrive on the pain relievers. The FDA had provided little guidance on required solutions, and IWG members had spent countless hours in meetings to arrive at a preliminary plan. At the Friday meeting, IWG representatives proposed a phased-in approach, including educational handouts for patients and training for prescribers to better educate them about the proper and safe use of opioid analgesics. This sounds simple enough, but there are several complications...
- As the IWG pointed out, the problems themselves — eg, misuse, abuse, addiction, overdose — are often poorly defined and available data are confusing and faulty. We have previously observed that those problems seem to have already leveled-off [see post 9/16/09]. And, in the total picture, the problems are of relatively small proportions; which, we acknowledged, “is actually a testament to the effectiveness of the FDA in evaluating, approving, and monitoring medications that are essentially safe when properly prescribed and taken as directed on the product labeling” [see post 9/12/09]. However, during the meeting, the shortcomings of the data were not fully considered.
- Some of the problems with opioids for the most part do not involve the patients for whom the drugs were prescribed; rather they are public health and community issues. Whether pharmaceutical companies should be held accountable for these problems such as non-medical use or abuse and whether they fall within the purview of the FDA are questionable. These implications were mentioned but not addressed at the meeting.
- Not only is the FDA demanding that the IWG come up with solutions to the alleged problems but that they measure the effectiveness of their REMS program in changing behavior. While assessing whether or not a new program works seems worthwhile, nobody knows exactly how to do this and there is a high likelihood that it cannot be done effectively or accurately. Despite this, the burden is clearly on the IWG to come up with solutions that will satisfy the FDA.
- There are no easy solutions for how people can be forced to behave in more responsible ways regarding opioid medications, or how practitioners can be made to acquire more and better education on safely prescribing the drugs. In their presentations, it was apparent that the IWG had considered these issues and that “making” people — whether professionals, patients, or the public — attend to education and change their behavior is a daunting task.
- After receiving more than 2,000 comments, the FDA apparently feels that they need more data and public input on the opioid REMS issue and has extended the time for comment submission to next October, 2010. And, they say that there will be more meetings, perhaps next spring. Yet, the FDA is urging the IWG to continue work on their opioid REMS, and to possibly start implementing their plans as soon as possible. Meanwhile, as noted above, separate REMS already have been introduced and proposed for Onsolis and Exalgo, respectively. These conflicting and confusing actions do not make sense.
- At no time has cost been mentioned; what will it cost to develop, implement, and evaluate the opioid REMS programs? How might these costs be reflected in product prices, and will patients still be able to afford the analgesics? It seems ironic that, at a time when Congress is wrestling with how to create a more cost-effective healthcare system in America, the FDA is encouraging a course of action that could significantly increase medication costs.
— correspondent Stewart B. Leavitt, MA, PhD