Monday, May 13, 2013

ASHP Kasey Thompson VP of Policy, Planning and Communication, Written Testimony Presented to Senate HELP Committee on May 9, 2013


Good morning and thank you Chairman Harkin, Ranking Member Alexander, and distinguished
Members of the Committee, for holding this hearing. My name is Kasey Thompson, and I serve
as Vice President of Policy, Planning and Communications at the American Society of Health-
System Pharmacists (ASHP). I am here today to provide ASHP’s perspective on the
Committee’s draft proposal on pharmaceutical compounding.
As stated in previous testimony, in the interest of patient safety, ASHP supports closing the
regulatory gaps for a category of commercial compounding outsourcers that we now refer to as
“compounding manufacturers,” and we applaud the Committee’s effort to accomplish closing
these gaps.
We believe this proposed legislation addresses the regulatory uncertainties that were caused
through the various challenges to Section 503A of the Food and Drug Administration
Modernization Act of 1997. Importantly, the Committee’s proposal leaves traditional
compounding as a core component of the practice of pharmacy under the sole purview of state
boards of pharmacy.
ASHP strongly supports the creation of a category known as “compounding manufacturer,”
which would fall completely within the purview of FDA. We further agree that not allowing a
compounding manufacturer to register as a pharmacy in any state establishes a clear boundary
between FDA jurisdiction and the jurisdiction of state boards of pharmacy. Being under the
purview of the FDA gives the public the certainty of knowing exactly which regulatory body is
accountable, and will help prevent an entity like the New England Compounding Center from
inappropriately operating as a pharmacy ever again.
Simply put, we believe the Committee got it right with this proposed legislation. The proposed
legislation assures hospital and health-system pharmacists, physicians, and other purchasers of
compounded products that compounding manufacturers that prepare sterile products have taken
the necessary steps to ensure their facilities meet the most rigorous Current Good Manufacturing
Practices, have been inspected by the FDA, and most importantly, do not pose a threat to our
patients due to inadequate regulatory oversight.
Under the proposal, health care providers will have the assurance that if they purchase an
outsourced sterile product from a compounding manufacturer, wherever it is located throughout
the country, that the product they purchase has come from an FDA-inspected and -approved
facility. We also agree that a compounded drug sold to a health care entity by a compounding
manufacturer should be labeled “not for resale.”
ASHP agrees that commercially available products should not be compounded except to meet
specific medical needs or if they are placed by the FDA on its drug shortage list. Furthermore,
there should not be any loopholes in the law that would enable an entity to circumvent the drug
approval process. We believe that the current approval processes for new and generic drugs
should be preserved as the gold standard, and in no way minimized or circumvented.
ASHP  continue reading here

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