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FOR IMMEDIATE RELEASE
Contact: Carolyn Hickey
Phone: 703-243-9262

Arlington, VA (May 5, 2004) – When providers access alternative sources for pharmaceuticals, especially outside the U.S., ensuring patient safety must be their top priority, regardless of financial considerations, according to testimony provided by the Health Industry Group Purchasing Association (HIGPA) at today’s Department of Health and Human Services (HHS) Task Force on Drug Importation hearing.

HIGPA’s testimony to HHS was two-fold. HIGPA President and CEO Robert Betz, Ph.D., submitted written testimony accompanied by the Association’s recently released report on pharmaceutical sourcing, while Allen Dunehew, Vice President of Pharmacy for Amerinet and Chairman of HIGPA’s Pharmacy Working Group, provided oral testimony.

In oral testimony, Dunehew acknowledged increased health care costs to providers, but stressed patient safety should be prioritized over financial concerns when contemplating reimporting pharmaceuticals outside the U.S. distribution system. Specifically, the HIGPA testimony states:

“It is recommended that providers who are interested in accessing pharmaceuticals from outside of the U.S. distribution system should first become involved in advocating for the implementation of systems that facilitate an electronic pedigree to insure the integrity of products and avoid an imported source until such safeguards are in place.”

Anything short of this may be construed as placing financial considerations above patient care and safety. We recognize that health care costs are escalating, and there is a constant need to relieve cost pressures. This is what GPOs strive to do everyday. Unfortunately, without the proper safeguards, importation provides more risk than the potential savings are worth. At the end of the day, we, as the primary contractors for the health care supply chain, must come down squarely on the side of what is in the best interests of the patients.”

HHS was authorized to form the Task Force following the adoption of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. The Task Force’s mission is to determine if drug importation can be conducted safely and what the potential impact would be on the health of American patients, medical costs, and development of new medicines. As part of their ongoing series of meetings, HIGPA was invited by the HHS Task Force to provide the health care supply chain’s perspective on importation for their fifth hearing focusing on the health care purchaser’s outlook. HHS has asked experts from consumer groups, medical professional groups, industry representatives, health care purchasers and associations to gather the best information to make an educated conclusion regarding importation.

“I commend HHS for recognizing the significant role HIGPA’s group purchasing organizations play in the health care supply chain marketplace by inviting us to testify at their May 5^th hearing on pharmaceutical importation,” said Dr. Betz. “I have submitted written testimony on behalf of the Association and have asked Allen Dunehew to provide oral testimony because he can provide a technical perspective based on his previous years as a pharmacist in the provider setting and now at a GPO assisting providers meet their specific needs in sourcing products.”

Both testimonies cited HIGPA’s Pharmacy Working Group’s attention to issues surrounding drug importation by health care providers and patients. The oral and written testimonies provide details of the HIGPA report titled, Integrity of the Pharmaceutical Supply Chain: Product Sourcing for Patient Safety. These suggestions outline the minimum safeguards that are critical to have in place prior to importation. They include:

• Electronic pedigree that can provide secure tracking of product at the individual package level throughout the supply chain regardless of its source.
• Development by the FDA of acceptable and efficient regulations on reimportation and importation to ensure product integrity of the imported product.
• Development of technology that tracks storage conditions and validates conformance to USP standards for products that require storage within a narrow temperature range throughout the supply chain.
• Assurance that entities in other countries, which export products to the U.S. market, are regulated appropriately, using the same standards as are required of U.S. supply chain participants.

Pursing importation as a cost savings strategy without implementation of the above safeguards places an undue risk on patient care and is counter to current initiatives to improve patient care and safety, the guidelines state.

The previously released HIGPA reimportation suggestions are available on the Association’s web site at http://www.higpa.org/pdf/02-09-04HIGPARxProductSourcing.pdf. For more information on the HHS Task Force on Drug Importation visit the agency on the Internet at http://www.hhs.gov/importtaskforce/.

HIGPA is a chartered trade association of over 175 health care purchasing and supply chain organizations. HIGPA's Industry Members include purchasing groups, associations, and health care provider alliances. HIGPA's Trading Partner members include many of the world's leading health care product manufacturers, distributors, wholesalers and related suppliers. According to a recent study conducted by a former principal analyst at the Congressional Budget Office, hospitals save patients over $30 billion each year by purchasing products through group contracts.

To learn more about HIGPA or the group purchasing industry, visit www.higpa.org or call 703-243-9262.

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