Obama urged to swiftly name FDA commissioner to shore up agency
Obama urged to swiftly name FDA commissioner to shore up agency
WASHINGTON -- President-elect Barack Obama should move fast to name a U.S. Food & Drug Administration commissioner if the administration "hopes to hit the ground running" on key issues, such as tightening import regulation, according to a Nov. 24 letter to Mr. Obama's transition team from the Alliance for a Stronger FDA, an umbrella group of 180 consumer, industry and health organizations advocating more money for FDA.
"During the last eight years, a confirmed FDA commissioner was at the helm less than half the time," the letter stated. "Since 1990, the transition period between confirmed commissioners has always taken a minimum of more than one year."
With so many policies at stake, the alliance says that FDA cannot wait a year for a Senate-confirmed commissioner. The agency is facing challenges through "high-profile public health episodes that include contamination of FDA-regulated products such as tomatoes and leafy green vegetables, pet food ingredients, and the drug heparin. At a rising rate, imported products are implicated, though domestic concerns continue as well," the letter added.
President-elect Obama last month named former South Dakota Sen. Tom Daschle to lead the Department of Health & Human Services, the parent organization of the FDA. He would replace HHS Secretary Michael Leavitt and is expected to have a say in the choice of a new FDA commissioner.
The group believes that not only should President-elect Obama move fast to install a new commissioner, he should also fulfill a campaign promise to pump more money into the embattled agency, which has been criticized for faltering in its science-based mission to protect consumers against unsafe drugs and foods.
Congress injected more money into FDA during the 2008-09 appropriation process, and as a result, FDA recently hired more inspectors and began shoring up its aging information technology system.
"But more needs to be done, and we respectfully recommend that FDA have an appropriated budget for fiscal year 2010 of $2.25 billion," asserted the alliance. This amount represents a 20 percent increase ($386 million) over the fiscal year 2009 baseline and a nearly 40 percent increase over the fiscal year 2008 baseline appropriations for FDA.
"The rapid appointment of an FDA commissioner and a properly funded FDA are needed to assure that Americans have safe foods and safe and effective medical products," concluded the letter, which was signed by the following Alliance leaders: Wayne Pines of the Alliance for a Stronger FDA; Caroline Smith DeWaal of the Center for Science in the Public Interest; Diane Dorman of the National Organization for Rare Disorders; Scott Faber of the Grocery Manufacturers Association; Andrew Emmett of the Biotechnology Industry Organization; and Nancy Myers of the Catalyst Healthcare Consulting Inc.
"During the last eight years, a confirmed FDA commissioner was at the helm less than half the time," the letter stated. "Since 1990, the transition period between confirmed commissioners has always taken a minimum of more than one year."
With so many policies at stake, the alliance says that FDA cannot wait a year for a Senate-confirmed commissioner. The agency is facing challenges through "high-profile public health episodes that include contamination of FDA-regulated products such as tomatoes and leafy green vegetables, pet food ingredients, and the drug heparin. At a rising rate, imported products are implicated, though domestic concerns continue as well," the letter added.
President-elect Obama last month named former South Dakota Sen. Tom Daschle to lead the Department of Health & Human Services, the parent organization of the FDA. He would replace HHS Secretary Michael Leavitt and is expected to have a say in the choice of a new FDA commissioner.
The group believes that not only should President-elect Obama move fast to install a new commissioner, he should also fulfill a campaign promise to pump more money into the embattled agency, which has been criticized for faltering in its science-based mission to protect consumers against unsafe drugs and foods.
Congress injected more money into FDA during the 2008-09 appropriation process, and as a result, FDA recently hired more inspectors and began shoring up its aging information technology system.
"But more needs to be done, and we respectfully recommend that FDA have an appropriated budget for fiscal year 2010 of $2.25 billion," asserted the alliance. This amount represents a 20 percent increase ($386 million) over the fiscal year 2009 baseline and a nearly 40 percent increase over the fiscal year 2008 baseline appropriations for FDA.
"The rapid appointment of an FDA commissioner and a properly funded FDA are needed to assure that Americans have safe foods and safe and effective medical products," concluded the letter, which was signed by the following Alliance leaders: Wayne Pines of the Alliance for a Stronger FDA; Caroline Smith DeWaal of the Center for Science in the Public Interest; Diane Dorman of the National Organization for Rare Disorders; Scott Faber of the Grocery Manufacturers Association; Andrew Emmett of the Biotechnology Industry Organization; and Nancy Myers of the Catalyst Healthcare Consulting Inc.
