BARNETT INTERNATIONAL CONSULTANT EDUCATES CONGRESSIONAL STAFF MEMBERS ON PDUFA
PHILADELPHIA, PA, March 25, 2002 — Richard J. Ciamacca, B.S., J.D., Senior Consultant with Barnett International, a subsidiary division of PAREXEL International Corporation (NASDAQ: PRXL), was invited to speak with United States Congressional staff members recently to educate them on the Prescription Drug User Fee Act (PDUFA) and the importance of its reauthorization. Without Congressional action, PDUFA will expire on September 30, 2002.
First authorized in 1992, PDUFA provides the mechanism for collecting fees from companies seeking approval for new products so that FDA has the necessary staff to conduct timely reviews of their new product applications.
Mr. Ciamacca possesses extensive knowledge of PDUFA law. A copy of his presentation is available at www.barnettinternational.com.
Barnett International is a division of PAREXEL International Corporation, one of the largest biopharmaceutical outsourcing organizations in the world, providing a broad range of knowledge-based contract research, medical marketing and consulting services to the worldwide pharmaceutical, biotechnology and medical device industries. With a commitment to providing solutions that expedite time-to-market and peak market penetration, PAREXEL has developed significant expertise in clinical trials management, data management, biostatistical analysis, medical marketing, clinical pharmacology, regulatory and medical consulting, industry training and publishing and other drug development consulting services. Its newest subsidiary, Perceptive Informatics, Inc., provides a variety of technology products and services, including web-based portal solutions and voice and data systems, which are designed to accelerate and enhance the clinical development and launch processes. The Company’s integrated services, therapeutic area depth and sophisticated information technology, along with its experience in global drug development and product launch services, represent key competitive strengths. Headquartered near Boston, MA, PAREXEL operates in 55 locations throughout 36 countries around the world, and has approximately 4,660 employees.
This release contains "forward-looking" statements regarding future results and events, including statements regarding expected financial results, future growth and customer demand that involve a number of risks and uncertainties. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words "believes", "anticipates", "plans", "expects", "intends", "appears", “estimates”, “projects” and similar expressions are intended to identify forward-looking statements. The Company's actual future results may differ significantly from the results discussed in the forward-looking statements contained in this release. Important factors that might cause such a difference include, but are not limited to, risks associated with: actual operating performance; actual expense savings and other operating improvements resulting from recent restructurings; the cancellation, revision, or delay of contracts, including those contracts in backlog; the Company's dependence on certain industries and clients; the Company's ability to win new business, manage growth, and attract and retain employees; the Company's ability to complete additional acquisitions and to integrate newly acquired businesses or enter into new lines of business; government regulation of certain industries and clients; competition and consolidation within the pharmaceutical industry; the potential for significant liability to clients and third parties; the potential adverse impact of health care reform; and the effects of exchange rate fluctuations. Such factors and others are discussed more fully in the section entitled "Risk Factors" of the Company's Form 10-Q for the period ended December 31, 2001, as filed with the Securities and Exchange Commission, which “Risk Factors” discussion is incorporated by reference in this press release. The Company disclaims any duty to update any of the forward-looking statements contained in this press release.