Washington, D.C. (June 22, 2010) — Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President Ken Johnson issued the following statement today regarding clinical trials conducted abroad:
“America’s biopharmaceutical research 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 2009 alone, invested an estimated $65.3 billion to discover and develop new medicines.
“While the number of experimental medicines in clinical testing today – more than 2,900 medicines for nearly 4,600 different indications – represents an all-time high, America’s biopharmaceutical research companies develop drugs for a worldwide market and conduct clinical trials inside and outside the U.S.
“It’s important to remember that the Food and Drug Administration (FDA) has jurisdiction over clinical trials conducted in foreign countries for drugs approved in the U.S. or being studied for approval in the U.S. The same strict regulatory standards apply to foreign trials as trials conducted domestically. Sponsors are typically in communication with the FDA throughout clinical trials – no matter where they are conducted.
“Clinical trials occur globally because we have global companies that make medicines for use around the world. Our member 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.
“Is it ethical to conduct such studies outside of the U.S.? In a word: Yes. Consistent with PhRMA’s Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results, our member companies are committed to adhering to Good Clinical Practice guidelines around the world.
“In fact, PhRMA has conducted educational seminars and symposiums – at times, in conjunction with the 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 Clinical Trial Principles, created in 2002 and strengthened last year, have been an invaluable guide to member companies and underscore our commitment to the safety of clinical trial participants and communication of important medical findings from clinical trials.”
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 $50.3 billion in 2008 in discovering and developing new medicines. Industry-wide research and investment reached a record $65.2 billion in 2008.
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