What the Food and Drug Administration and the Pharmaceutical Industry Could Better Understand about Each Other
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WHAT THE FOOD AND DRUG ADMINISTRATION AND THE PHARMACEUTICAL INDUSTRY COULD BETTER UNDERSTAND ABOUT EACH OTHER THERESA L. GERRARD,PHD* President, TLG Consulting Inc., Midlothian, Virginia
Although the Food and Drug Administration (FDA) and the pharmaceutical industry share a common goal in bringing safe and effective medicines to the public, each has misunderstandings about the other: Dispelling some of these misunderstandings about each other could speed the drug development process by virtue of better communication. FDA could have a better understanding of the pharmaceutical industry with regard to: the time and costs for clinical trials; assurance of consistency in package inserts f o r differentproducts in the same clinical indication: understanding of why data in scientific papers might differ from those in package inserts; and recognition of industry expertise in specific clinical areas. The pharmaceutical industry could better understand the FDA with regard to: recognition of the professionalism of FDA reviewers and the valuable resource that FDA can provide; willingness to contribute by providing new data to the FDA that can shape policy: understanding the acceptability of seeking another opinion within the FDA: and willingness to provide a comprehensive interpretation of safety and efJicacy data. Key Words: Food and Drug Administration; Pharmaceutical industry; Understanding
INTRODUCTION AS THE NEW FDA Commissioner, Dr. Jane Henney will have many challenges. Whether the challenges are internal, such as management and organizational changes, or external,
Reprint address: Theresa L. Gerrard, PhD, President, TLG Consulting Inc., 14521 West Salisbury Rd., Midlothian,VA 23113-6455. *Dr. Gerrard worked at the FDA for 11 years and was the dmctor of the Division of Cytokine Biology in CBER. She was also the director of Development for Amgen Boulder and now works as a consultant to the pharmaceutical industry in the areas of regulatory strategy and product development.
such as implementation of the FDA Modernization Act, effective communication will be essential. In fact, at a Food and Drug Law Institute meeting, Linda Suydam, FDA associate commissioner for strategic management, identified better communication as a key goal because it is considered a highly influential issue which will impact a wide range of topics (1). It is doubtful that anyone within the FDA or the pharmaceutical industry would disagree with the goal of better communication. It is also doubtful that despite good intentions, any two people could agree on what better communication actually means.
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Theresa L. Gerrard
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In the hope of helping to improve communication between FDA and the pharmaceutical industry, this article outlines some issues that each could better understand about the other. There are two parts in this article; the first part deals with issues about the pharmaceutical indust
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