Monday, May 13, 2013

Testimony before the Committee on Health, Education, Labor and Pensions United States Senate May 9, 2013 Allan Coukell, Senior Director of Drugs and Medical Devices The Pew Charitable Trusts


Testimony before the Committee on Health, Education, Labor and Pensions
United States Senate
May 9, 2013
Allan Coukell, Senior Director of Drugs and Medical Devices
The Pew Charitable Trusts
Dear Chairman Harkin, Ranking Member Alexander and members of the Committee,
Thank you for the opportunity to testify on your proposal to improve the safety of pharmaceutical compounding.
My name is Allan Coukell. I am a pharmacist and director of drug and medical device work at the Pew Charitable Trusts, an independent, nonpartisan research and public policy organization.
Pharmacists have always compounded medicines – it is the origin of the profession – but the activities you seek to address today are far removed from the traditional practice of preparing individualized medicines for one patient at a time.
Today, some compounders produce large volumes of drugs, often manufacturing them before a prescription is received, shipping many thousands of units– high-risk or sterile products – to clinics and hospitals across the country.
The regulatory framework has not kept up with this changing industry. Traditionally, states oversee pharmacy practice and the FDA oversees drug manufacturing. But compounding falls into a grey zone. In a very broad sense, FDA has the authority to regulate some compounding activities, but it is not at all clear how far that authority goes. Nor are there formalized mechanisms to divide the oversight of compounding between the states and FDA.
Examining the Risks
The epidemic caused by the New England Compounding Center is but the most recent case highlighting the risks to patients.
That outbreak has been associated with 53 deaths so far and nearly 700 serious infections. Included with my testimony is a Pew summary that describes 19 additional pharmacy compounding errors since 2001.1
The list includes 22 additional deaths, as well as serious infections – meningitis, bloodstream and at least 38 patients who suffered partial or complete loss of vision – but also patients harmed by sub-potent or super-potent doses. For example, in 2007 three people died after receiving intravenous colchicine that was eight times the labeled strength.2
Recent inspections of compounders raise further concern: Two months ago, the FDA announced a recall of all of the products manufactured by a New Jersey compounder because of potential mold contamination. The FDA press release referred to “visible particulate contaminants” in what was
supposed to be a sterile product.3 Also this year, a Georgia compounder conducted a nationwide recall of sterile products after reports of serious eye infections.4
Appropriate Oversight and Quality Standards
Congress has long grappled with these risks. The current section 503(A) of the Food, Drug and Cosmetic Act was passed in 1997. After the courts struck down parts of that provision, members of this committee tried again to create meaningful Federal oversight of certain compounding activities. But that legislation was strongly opposed by the compounding industry, and did not pass. Today, FDA’s legal authority remains unclear. Even as the Agency steps up its oversight of compounders, its ability to access records has been challenged.5
The proposal before you today offers an opportunity to finally address some, though not all, high-risk compounding activities. It has the following strengths:
 It addresses sterile products, which are particularly high risk,
 By including facilities that sell in multiple states, it will capture many of the largest operations, and
 It contains safeguards that will help prevent compounders from undermining “gold-standard,” FDA-approved drugs.
Increased Federal Oversight
The legislation creates a new category of FDA-regulated “compounding manufacturers” – compounders that produce sterile products in anticipation of a prescription and who sell product outside the state in which it is created.
The bill would require compounding manufacturers to comply with the same manufacturing quality standards, known as good manufacturing practices (GMPs), that apply to pharmaceutical companies making FDA-approved drugs.
This recognizes that the United States Pharmacopeial standards (chapter 797) used in many states are unsuited to large-scale anticipatory production. Pew recently joined with the American Hospital Association (AHA) and the American society of Health-System Pharmacists (ASHP) to co-host a pharmacy compounding summit that heard from experts who stressed this point strongly. The FDA, and not state pharmacy boards, is the appropriate agency to enforce GMPs.
Using limited resources wisely necessitates addressing the largest potential public health problems first. That means, in part, ensuring quality standards at facilities that produce large numbers of doses. While not perfect, we believe that the proposed framework for interstate sales would capture a meaningful portion of the highest-risk compounding.
However, we urge the committee to not exclude mixing and reconstituting of drugs in accordance with manufacturer label from the definition of compounding manufacturer. If these ostensibly sterile products are mixed in large volume under unsanitary conditions, it could represent a significant public health risk

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