Do you obtain compounded medications for your child?
Do you work with a doctor out of your home state?
If you answered yes to one or both of these questions, please read on. There is a potential Senate bill that could greatly affect your family.
First some background: You have may or may not have heard that a rogue pharmacy acting like a manufacturer, the New England Compounding Center (NECC) in Massachusetts, apparently violated numerous state and federal laws and distributed contaminated medications that, sadly, resulted in the deaths of more than 50 people and made many more gravely ill. We all want our medications to be safe, and we applaud those who look out for our safety and the safety of our children.
What is at stake: Legislation that has just been approved by a U.S. Senate Committee in Washington to address the NECC situation, S.959 has far-reaching implications for the Autism Spectrum Disorder (ASD) community and for others who depend on compounded medications. Whether intended or unintended, access to important compounded medications that are used to treat children with ASD could be restricted or effectively denied by S.959. This is largely because, under this bill, the FDA is given expansive and unchecked authority to control the compounded medications we depend on.
What this bill will affect: This new bill, S.959, could directly affect your ability to obtain sterile medications such as Glutathione and Methyl B12 for your children, especially if you get your medications from a compounding pharmacy located in another state. But it can even affect the availability of the sterile compounds you get within your own state. Moreover, the doctors who treat children with ASD may not be able to work with the pharmacies they work with now.
Now some of the details:
- If S.959 passes as written, many compounding pharmacies that now serve the ASD Community may be forced to either (1) stop compounding sterile medications altogether or (2) eliminate interstate sales of sterile medications.
- A new type of entity that the bill creates, called “compounding manufacturers,” will be able to sell sterile medications across state lines. But they will concentrate on large volume markets like hospital drug shortages and not on special needs patients like children with ASD. They would be prohibited by the law from filling prescriptions.
- The FDA gets far more authority over non-sterile compounded medications (pills, tablets, suspensions, creams, etc.). If your child needs a version of an FDA-approved drug, with preservatives, gluten or sugars removed, FDA would have the authority to make your doctor justify the compounded variations you need. FDA could require burdensome new paperwork.
- FDA has the power to remove compounded medications from the market if they don’t think they are appropriate.
The bottom line: Your medication options could diminish; you and your doctor may not be able to do business with the compounding pharmacy you currently use; and your costs could go up significantly.
It only takes a few minutes to voice your concern: Please pass this information on to others. We encourage you to contact your elected representatives in Washington, D.C. and let them know of your strong opposition to S.959 as it is currently written.
To connect with your members of Congress and for a sample email to send, visit www.protectmycompounds.com.