From U.S. Representative Morgan Griffith (R-VA-9):
Recently, I was contacted by my allergists about the United States
Pharmacopeia’s (USP) proposed revisions to sterility standards for the
compounding of drugs, including allergen immunotherapy. USP is a non-profit
organization that publishes drug formularies and quality standards, and these
standards are sometimes enforced by the Food and Drug Administration (FDA) for
drug manufacturers and pharmacies. My allergists are concerned that these new
standards may have adverse effects on the availability and affordability of
allergy shots, so my office is reviewing the proposal and plans to meet with USP
to discuss it.
As you are aware, I led the charge in Congress to enact
new, common-sense regulations on compounding pharmacies which distinguished them
from illegal drug manufacturers like the New England Compounding Center, whose
tainted sterile injections led to a fungal meningitis outbreak of 2012. In
fact, the bipartisan legislation that I worked on called at one point for
national adoption of USP sterility standards for all compounding pharmacies. I
believe we need such a standard to protect the public health of our citizens,
but likewise, I want to ensure that any revisions do not become so burdensome
that we eliminate affordable access to useful treatments like custom allergy
shots that many in our tree- and forest floor-rich area receive.
like my allergists, may have a federal problem, please don’t hesitate to let my
team and I know. Part of my job as your Representative is to try and help you
address federal issues you may be having. Of course, I can’t work to fix a
problem if I am not aware it exists.
If you have questions, concerns, or
comments, feel free to contact my office. You can call my Abingdon office at
276-525-1405 or my Christiansburg office at 540-381-5671. To reach my office
via email, please visit my website at www.morgangriffith.house.gov. Also on my
website is the latest material from my office, including information on votes
recently taken on the floor of the House of Representatives.