ESTABLISHMENT OF PRODUCT QUALITY RESEARCH INSTITUTE (PQRI) AIMS AT ADVANCING FDA'S FAST-TRACK PROGRAM

American Association of Pharmaceutical Scientists Tapped to Manage PQRI

Alexandria, VA -- November 16, 1999 -- In effort to reduce the regulatory burden on the Food and Drug Administration (FDA) and the pharmaceutical industry, the American Association of Pharmaceutical Scientists (AAPS) announced today the formation of the Product Quality Research Institute (PQRI). The goal of this collaborative effort between the government, industry and academia is to produce science-based policy that ensures quality reviews without unnecessary testing. The Institute's recommendations are expected to speed new drug approvals and reduce the industry's cost for pharmaceutical development. Ultimately, the public will benefit because of lower costs and faster availability of new drugs for life-threatening diseases.

"We are not testing actual drugs," said Larry Augsburger, AAPS President. "We are testing processes and procedures that will be used to help verify pharmaceutical properties and their effectiveness. Recommendations will help fast-track pharmaceuticals, benefiting all Americans, especially those who currently have no disease treatment options available."

How PQRI Works

Under the purview of AAPS, PQRI will consist of a board of directors, a steering committee and technical committees. The five-member board of directors is charged with the administrative management and operations of the Institute. The board has authority over the collection and disbursement of funds and the administrative procedures required to guarantee effective operations.

Following the lead of the technical committee, working groups of scientists will perform research projects aimed at streamlining policy, while still ensuring the highest level of product quality. The technical committee then reviews the findings for scientific validity. Assuming approval, the steering committee votes on whether or not to make a recommendation to the FDA. The FDA can either accept or reject the findings.

"PQRI represents a unique collaboration between FDA, industry and academia to determine the optimum type of information to be included in a regulatory submission to document product quality attributes," said Roger Williams, Deputy Director of the Center for Drug Evaluation and Research (CDER) at the FDA. "It provides a 'Win-Win-Win' opportunity for the industry, FDA/CDER and most importantly, the public."

Founding Members

PQRI Founding members include: AAPS, CDER, FDA, Pharmaceutical Research and Manufacturers of American (PhRMA), Generic Pharmaceutical Industry Association (GPIA), National Association of Pharmaceutical Manufacturers (NAPM), National Pharmaceutical Alliance (NPA), Consumer Healthcare Products Association (CHPA) and Parental Drug Association (PDA). No member will be compensated in any way for their participation in PQRI.

In an effort to reach the scientific community worldwide with its findings, PQRI has established a public website where all recommendations will be published. The site is located at https://www.pqri.org.

AAPS is a professional, scientific society of more than 10,000 members employed in academia, industry, government and other research institutes worldwide. Founded in 1986, AAPS aims to advance science through the open exchange of scientific knowledge, serve as an information resource, and contribute to human health through pharmaceutical research and development.

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