Washington, D.C. (February 19, 2009) – Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President Ken Johnson today issued the following statement on clinical trials conducted abroad:
“America’s pharmaceutical research and biotechnology companies are proud to be among the nation’s primary economic engines. Pharmaceutical research companies lead the world in the search for new life-saving and life-enhancing medications and, in 2007 alone, invested an estimated $58.8 billion to discover and develop new medicines.
“As the authors of this week’s New England Journal of Medicine article note, increasingly drug discovery has become an international endeavor. While the number of experimental medicines in clinical testing today – more than 2,700 medicines for nearly 4,600 different indications – represents an all-time high, America’s pharmaceutical research and biotechnology companies develop drugs for a worldwide market and conduct clinical trials inside and outside the U.S.
“Our companies make every effort to combat diseases that are common in the developed, as well as the developing world. That can, ultimately, deliver life-saving and life-enhancing medications to patients around the world more quickly.
“In addition, it’s important to remember that, in order to market products in India and China, America’s pharmaceutical research companies often conduct clinical trials in those countries. Japanese regulators often require such studies among their citizens to ensure that unique ethnic differences can be captured by the clinical research.
“Is it ethical to conduct such studies outside of the U.S.? In a word: Yes. Whether the clinical research occurs in the U.S. or outside its borders, our member companies must adhere to Good Clinical Practice guidelines.
“In fact PhRMA has conducted educational seminars and symposiums – at times, in conjunction with the Food and Drug Administration (FDA) – in other countries to educate potential clinical trial principal investigators about Good Clinical Practices, ethics oversight by outside review boards, and the need to maintain the highest standards for data quality.
“Regardless of the location, however, companies seeking U.S. approval must maintain the FDA’s high standards for conducting the trial. For instance, any related trials conducted outside the U.S. must comply with FDA requirements covering Good Clinical Practices, in addition to meeting the requirements mandated in these important emerging markets.
“Clinical research is a critical element in the development of revolutionary medicines that help patients live longer, healthier lives. Through carefully controlled clinical studies, researchers thoroughly assess the safety and efficacy of new drug candidates.
“America’s pharmaceutical research and biotechnology companies have a long-standing commitment to help ensure physicians and other healthcare providers receive meaningful information from these clinical trials.
“The PhRMA Principles for the Conduct of Clinical Trials and Communication of Clinical Trial Results, created in 2002 and updated in 2004, have been a valuable guide to member companies and underscore our commitment to the safety of clinical trial participants and communication of important medical findings from clinical trials.
“PhRMA continually reviews such guiding principles, taking a fresh look at the documents and – as appropriate – revising them.”
The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. PhRMA companies are leading the way in the search for new cures. PhRMA members alone invested an estimated $44.5 billion in 2007 in discovering and developing new medicines. Industry-wide research and investment reached a record $58.8 billion in 2007.
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