S.959: What is it and Why Should You Care?
If you are a faithful reader of my blogs – and if you’re not you should be – then you might remember a few posts I did last year on a certain brouhaha surrounding compounding pharmacies.
One of the first posts I wrote (which you can find here) explored the safety of compounding pharmacies. The post was in response to a fungal meningitis outbreak which occurred about this time last year, after The New England Compounding Center (NECC) in Farmington, MA, shipped 17,000 vials of a contaminated steroid used to treat back pain to patients in 23 states.
Hundreds of people were infected and between 25 and 30 people have died. In 2013, the fall out continues as more and more people manifest the symptoms of fungal meningitis. It was and continues to be a major health scandal.
At the time of the outbreak, I expressed a concern that the fall out from the scandal was going to reach far and wide. I predicted (though to be honest, the prediction was pretty obvious) that we could expect more federal legislation affecting compounding pharmacies to be forthcoming.
At the end of 2012, Massachusetts Governor Deval Patrick proposed new state legislation which required special licensing for compounding pharmacies and gave the state Board of Pharmacy the authority to fine companies which violate the rules. The legislation also required that pharmacies which ship drugs into the state be licensed by the state as well.
Not such a bad thing, and frankly, more state regulation of compounding pharmacies was not what concerned me. It was more federal regulation that I didn’t want to see. For those of you who think more government is the answer to all of our problems, then you might think my concerns are unwarranted.
However, for those like me, who quite frankly would like to see the reach of the federal government severely limited, then a new bill, S.959, which is currently being debated in the Senate, might be of interest to you.
The bill is in response to the fungal meningitis outbreak which occurred last year, and as it is written, gives the Food and Drug Administration (FDA) increased authority over compounding pharmacies. This increased authority will allow them to make arbitrary decisions as to what can and cannot be compounded.
Again, why does this matter, and why should you care?
Well, if you are a woman who currently gets bioidentical hormones from a compounding pharmacy, this matters a lot. While no one in their right mind would or should object to regulating compounding pharmacies, I believe (as do millions of others who would be affected by this law) that any regulation of compounding pharmacies should remain under the oversight of the State Boards of Pharmacy, who, by the way, actually do a pretty stellar job.
Beyond that, my personal concern is that if the FDA is given more power to regulate, and to decide which medications can or cannot be compounded, the war between pharmaceutical companies, who would rather that we ALL take drugs manufactured ONLY by them, and those who wish to choose compounded bioidentical hormones will become ugly and bloody.
If you would like to read more about S.959 and send an email to your congressman or congress woman expressing your concerns, you can find that here, at Mymedsmatter.com. I know we’re not all born to be social and political activists. But it only takes a moment to make your voice heard!
Magnolia Miller is a certified healthcare consumer advocate in women's health and a women's freelance health writer and blogger at The Perimenopause Blog.