Now that we have talked a little (okay, a lot) about the problem, what are the solutions? Let me remind you how we started, “This is a complex issue”. Not what we want to accept nor do I think we should settle on that but I just want to be clear that the solutions are not quick or easy.
Let’s start with the manufacturers. We should continue to hold them to the highest quality standards. Period. There should be an expectation that they have a certain amount of stock in supply and if not, the manufactures should be required to notify the FDA of a potential shortage situation.
Now to the money. I certainly do not know how it could be done, but the creation of some system whereby a minimum price threshold is in place (and a maximum, too) allowing some level of stability in the price (which would allow manufacturers to predict supply and plan for equipment repairs, etc). Tax credits or other financial incentives (bonus) for manufacturers who demonstrate consistent level of good performance was mentioned.
We need to deal with behaviors. Stock piling behaviors should be discouraged so that the natural purchase and use of medications can occur instead of them potentially sitting on someone’s shelf when they could be used for someone else’s patient. We need to explore more the gray market and act as appropriate to minimize or stop its operations. And we can start by encouraging our healthcare organizations to purchase only from reputable distributors.
The U.S. Food and Drug Administration (FDA). We need to support their commitment to quality. To be very direct, the FDA has a shortage of resources in money and people. Truthfully, I am not in a position to say if they lack money or efficiency, but I would guess it is a little of both as it is with many large organizations in general. What is clear is that a backlog of 24-30 months (2 to almost 3 YEARS) to approve a new generic medication is not ideal or even acceptable given the survival times of the cancers they are intended to treat. We need to think about how to fix this with them.
So what can you do? First, I would say not to panic about this situation. A healthy amount of concern is definitely warranted, but for the most part (although not all) there are still substitute medications available to treat most patients. If you are concerned about your own situation, I would encourage you to talk with your healthcare team. I guarantee they have already had to deal with a shortage and they have a plan in place to continue your care. I would also remind you that you are welcome to participate in one of our online or in person groups (information can be found on this website). Next, take an active role in communicating with your law makers. Particularly on the issue of securing the resources the FDA needs to maintain a high quality and efficient drug supply. There is currently an effort to pass a generic user fee if you agree with this as a potential solution, let your representative hear from you. Finally, if you have thoughts on this issue, please let me hear from you. One member of our team raised the thought that we should look at this in the same way we do the public utility (water, electric, etc.) industry. Personally, I think that is a very interesting idea and I suspect you have others that may be helpful if placed in the right hands. We are happy to carry your thoughts to those we can.
As a point of summary what should you remember? 1. Continue to educate yourself on the issue. 2. Stay involved in your care with your healthcare team. 3. If you have an opinion on an action or solution, communicate to your representative or the FDA. 4. If you are feeling anxious about this or want to join others like you, participate in one of our programs or one of those offered by our partners in the advocacy community.
Thank you for spending time with me on this issue. I look forward to hearing your thoughts.