PhRMA Statement Regarding Non-Inferiority Trials

Washington, D.C. (March 17, 2008) —Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President Ken Johnson today issued the following statement on non-inferiority trials:

“Drug approval decisions based on endpoints approved by the Food and Drug Administration (FDA) often allow patients to access life-saving and life-enhancing remedies more quickly.

“When America’s pharmaceutical research companies design such clinical trials, they do so in close consultation with the FDA. The FDA also relies on its outside expert advisory committees to review, discuss and to recommend the agency approve promising therapies.

“The use of non-inferiority trials can help to expedite the clinical development process for pharmaceutical research companies seeking to slow the emergence of drug-resistant bacteria.

“We applaud the attempts by the FDA to clarify important issues regarding non-inferiority studies, but remain disappointed that agency’s new draft guidance leaves unanswered such key questions as the role of preclinical data and clinical judgment.

“It would be unfortunate if there were a situation in which the research community felt it could only study very limited subsets of important infectious diseases. What’s more, creating insurmountable regulatory requirements could result in fewer scientific discoveries that can advance public health by leaps and bounds.

“Consider ciprofloxacin. Had the FDA not approved that medicine to treat common infections, it’s highly unlikely that researchers would have realized its utility for treating exposure to anthrax or typhoid fever.

“In the face of rising levels of antibiotic resistance, we remain concerned about increased regulatory hurdles that could complicate or slow the approval of promising therapies. Drug development could slow, as companies create and conduct lengthy, complicated clinical trials. America’s patients could suffer, if they were forced to endure delays in accessing promising therapies.”

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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 $43 billion in 2006 in discovering and developing new medicines. Industry-wide research and investment reached a record $55.2 billion in 2006.

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