In November 1997 ISPE was honored by the Center for Drug Evaluation and Research (CDER) with a Special Recognition Award. The ISPE/FDA team that developed the similar pharmaceutical manufacturing equipment list was recognized for invaluable service and commitment to the American public by providing technical support to the US Food and Drug Administration in the development of the SUPAC-IR Equipment Guidance. On hand to receive the award were Robert P. Best, ISPE President/CEO; Larry W. Kranking, Vice President, Production Operations, Eisai Inc.; Russ Somma, PhD, Head, Process Development Solids, Novartis Pharmaceuticals Corp.; and Joseph X. Phillips, Deputy Regional Food and Drug Director, FDA Central Regional Office, Philadelphia, Office of Regulatory Affairs. The recipients were recognized for outstanding leadership in facilitating the partnership between FDA and ISPE which resulted in the successful development of the SUPAC-IR Equipment Guidance.

A partnership of the Food and Drug Administration (FDA) and ISPE that can save industry millions of dollars and benefit consumers has been selected for the "Hammer Award" from Vice President Al Gore. The ceremony honoring the FDA-ISPE team took place 3 November, 1997 as part of ISPE's Annual Meeting in Marriott's Marco Island Hotel in Florida.

The award-winning team of ISPE engineers and FDA's drug and enforcement experts developed a list of "similar equipment" needed for efficient implementation of Scale-Up and Post-Approval Change (SUPAC) guidance for products in immediate release-solid oral dosage form.

The guidance and the "Similar Equipment List" provide a substantive regulatory relief in filing of change information, and thereby bring significant savings to the industry. The list, which has been published in the Federal register, is available on FDA's Web site.

"This project demonstrates the benefits of cooperation between government and industry," said Bob Stone, Director of the Vice President's National Performance Review Office. "It reduces red tape, saves FDA's and manufacturers' resources, and helps hold down the cost of health care, without lowering the product standards."

The award was received by Joseph X. Phillips, Deputy Director for FDA's Central Region, Dr. Roger Williams of FDA's Center for Drug Evaluation and Research and Larry Kranking, ISPE Past President, on behalf of the FDA specialists and pharmaceutical engineers who worked together on the project.

The Hammer Award is given to federal employees and their private sector partners who have advanced the Vice President's National Performance Review by cutting red tape, improving services to customers, and helping build a better and more cost-effective government.

Phillips had been working closely in another cost-saving partnership with ISPE known as the "Baseline® Pharmaceutical Engineering Guides." He and his Mid-Atlantic group were the primary facilitators with ISPE on the technical aspects of the Similar Equipment List. Williams and his staff were prominently involved in the original creation of the SUPAC guidance. Several additional documents are being prepared under Williams' leadership.

Kranking, Vice President, Production Operations for Eisai, Inc., developed the ISPE management plan, recruited the project team and became its first chair, and established the format for the document. He passed the chairmanship reins to Russ Somma, Assistant Director, Process Development Solids, Novartis Pharmaceuticals, whose Steering Committee and Task Teams completed the work.

"We turned to ISPE because they have a worldwide network of 10,000 engineers with broad-based experience with manufacturing equipment," said Phillips. "We have had an excellent relationship with ISPE over the years and had proven we could accomplish important tasks together through the Baseline® Guide series. The SUPAC Similar Equipment List is another tangible example of how the consumer can benefit when industry and government collaborate."

ISPE is the first pharmaceutical society to receive the Hammer Award.

ISPE President and CEO, Robert P. Best (left) accepting citation from Sharon Smith Holston, Deputy Commissioner for External Affairs, FDA (center), as James T. Murphy, Chairperson, Pharmaceutical Advisory Council, looks on.

On behalf of ISPE, Robert P. Best, President and CEO, accepted the FDA Commissioner's Special Citation "in appreciation of outstanding cooperation with the Food and Drug Administration in providing vital support to the industry through educational and special projects, nationally and internationally." Sharon Smith Holston, Deputy Commissioner for External Affairs, FDA, presented the award to Best on 4 June 1997 at the ISPE Rockville Conferences. As part of the citation, Best received the Harvey W. Wiley Medal, the Father of the Pure Food and Drug Law.