PhRMA hopes Obama will usher in change at the FDA

November 12, 2008

Pharmaceutical Research and Manufacturers of America (PhRMA) President and CEO Billy Tauzin today expressed his hope that the next head of the U.S. Food and Drug Administration can work with diverse constituents and improve the agency?s scientific bases.

Pharmaceutical Research and Manufacturers of America (PhRMA) President and CEO Billy Tauzin today expressed his hope that the next head of the U.S. Food and Drug Administration can work with diverse constituents and improve the agency’s scientific bases.

Barack Obama will become the 44th president of the United States next year. With the new president will come new appointments. Obama has named Rahm Emanuelas the future chief of staff. While there are rumors of the other members in Obama’s administration, none have been named yet. But PhRMA is preparing for new leadership to be ushered in.

“We look forward to President-elect Barack Obama’s transition team’s expeditious selection of a future leader for the Food and Drug Administration,” Tausin said. “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.” He said the ideal candidate for the FDA should embrace the “need to advocate for an empowered” administration that is adequately resourced to carry out its crucial mission.

He added that the individual also must have strong managerial skills that are essential for directing science-based activities at the FDA. Senate Democrats could seek support from across the aisle to push several bills opposed by industry, and use hearings and investigations to shine the spotlight on drug companies and the FDA. Congress has a lengthy agenda for FDA overhaul.

Rep. John Dingell, chairman of the House Energy and Commerce Committee, has introduced tough legislation that would add new fees on imports to help pay for more inspections of foreign plants and incoming drugs and food. Also, congressional Democrats want to give the FDA oversight of tobacco products. The bill would create a separate wing at the FDA and establish strict regulations for U.S. cigarette and smokeless-tobacco makers involving marketing and the development of new goods.

“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,” he said. “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 .”

A big challenge facing a new FDA administrator will be rebuilding the agency's staff of scientists. An advisory committee warned this year that the FDA lacks scientists with experience in biologics and cell-based therapies. Among possible candidates to lead the FDA is Steven Nissen of the Cleveland Clinic, whose medical articles on, and criticism of, several popular drugs and the FDA have angered drug makers.