Press Release

PhRMA Statement Regarding FDA’s Drug Safety Oversight

PhRMA April 30, 2013

Washington, D.C. (August 2, 2010) — Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President Ken Johnson issued the following statement today regarding the safety of drug ingredients derived from abroad:

“The lifeline of America’s biopharmaceutical research companies is the safety and integrity of the products they develop. Brand-name pharmaceutical companies make tremendous investments in quality control systems and take extensive measures to help protect patient safety and to help prevent adulterated ingredients from entering into America’s prescription drug supply.

“In addition, drug manufacturing for the U.S. market – regardless of where it occurs – is regulated under Good Manufacturing Practices (GMP) by the Food and Drug Administration (FDA). These GMP requirements help to assure the safety, quality and purity of drug ingredients that are used in the U.S. prescription drug supply.

“The U.S. regulatory system for prescription drugs is the toughest and safest in the world.
“PhRMA and its member companies have been working with Congressional leaders over the last several years on ideas for making further improvements to the safety of our drug supply. We look forward to reviewing U.S. Sen. Michael Bennet’s bill closely as part of that continuing effort.”

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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