PhRMA Statement on a 21st Century FDA, Commissioner

Washington, D.C. (November 5, 2008) – Pharmaceutical Research and Manufacturers of America (PhRMA) President and CEO Billy Tauzin today issued the following statement regarding the potential for new FDA leadership:

“We look forward to President-elect Barack Obama’s transition team’s expeditious selection of a future leader for the Food and Drug Administration (FDA).

“Due to the vital nature of the FDA’s public health oversight, identifying a strong, independent FDA Commissioner should be among the first accomplishments of the new Administration.

“The ideal candidate should embrace the need to advocate for an empowered FDA that is adequately resourced to carry out its crucial mission. The individual also must have strong managerial skills that are essential for directing science-based activities at an Agency that has just expanded its ranks with hundreds of new employees.

“These skills are particularly important to an Agency that is striving to implement groundbreaking reforms to better position itself to tackle future challenges, including modernizing FDA methods for evaluating safety and efficacy throughout a product’s life cycle.

“The new leadership will be tasked with deftly implementing newly granted authorities, and prioritizing the allocation of bolstered Congressional appropriations and enhanced user fees paid by America’s pharmaceutical research and biotechnology companies.

“An incoming FDA Commissioner also will work with diverse partners, including researchers, Congress, the White House, patients and pharmaceutical research companies on such measures as the Critical Path Initiative, which propels the agency into the 21st Century by improving the scientific bases for product development and manufacture.”

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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 $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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