Senate Panel Assails FDA Funding

According to this week’s bipartisan Senate panel meeting, the US Food and Drug Administration (FDA) does not have adequate funding “to adequately protect the nation’s increasingly global supply of food and <"https://www.yourlawyer.com/practice_areas/defective_drugs">drugs.”  The lawmakers confirmed that the FDA needs millions more dollars than the $2.4 billion the Bush administration requested for 2009 to keep up with the much-needed inspections of overseas manufacturing plants and to monitor drug side effects and food contamination.  “There is no new money for food safety, medicinal products safety or anything else,” said Herb Kohl, a Wisconsin Democrat and chairman of a Senate appropriations subcommittee. “I find that troubling.”

These discussions follow the most recent drug scare, over contamination of a raw ingredient made in China and a component of Baxter International Inc.’s blood thinner heparin as well as numerous reports of tainted pet food and bacteria-laced peanut butter, spinach, and lettuce.  Heparin was linked to dozens of deaths and adverse reactions in over 700 patients.  Millions take heparin annually to avoid potentially life-threatening blood clots.

Senator Robert Bennett of Utah, the panel’s top Republican, did defend the FDA’s overall performance, but added, “The budget that has been submitted by the administration appears to me to be inadequate to meet those challenges.”  The panel is currently reviewing how much taxpayer money will be needed for the FDA for fiscal year 2009, which starts in October.  External experts assembled by the FDA said the agency needs an additional $375 million to improve its oversight of those products that comprise about 25 percent of the US economy.

FDA Commissioner Andrew von Eschenbach, whom President George W. Bush appointed, said the FDA would have trouble using such a large sum in one year, but could use $100 million and would use some of the funding to create new FDA offices overseas, including in China.  Meanwhile, the FDA is creating a temporary facility in Beijing next month, hoping to make it official by September. Two other FDA offices are planned in Shanghai and Guangzhou for a total of 13 employees in China and the FDA is hoping to have five offices overseas and is looking at setting up offices in India, the Middle East, Latin America, and Europe.  Additional funding could also go toward upgrading the agency’s antiquated systems, von Eschenbach added.

The FDA focuses on domestic companies, with about 1,200 inspections conducted annually in the US; however, only about 300 foreign facilities are inspected annually.  In November, the Government Accountability Office found the FDA didn’t know how many foreign firms are actually subject to inspection and the FDA could not confirm how many foreign firms have never been inspected.  The agency has a list of 3,249 firms, but at the current rate of inspection, it would take the FDA over 13 years to go through each firm on its list.  Today, approximately 80 percent of all active drug ingredients come from abroad.  Worse, many of these drug-manufacturing plants are in developing countries that don’t have infrastructure that meets U.S. safety standards.