To Beef Up Overseas Inspections

To Beef Up Overseas Inspections

FDA Seeks Extra $275 Million

By JARED A. FAVOLE

WASHINGTON -- Facing congressional demands to expand overseas inspections, the Food and Drug Administration commissioner said the agency needs an extra $275 million to help ensure the safety of foods, drugs and medical devices.

The request from Commissioner Andrew von Eschenbach, in a May 5 letter to Sen. Arlen Specter (R., Pa.), parallels an FDA funding proposal that key Senate Democrats plan to begin moving this week. The content of Dr. von Eschenbach''s letter was reported Wednesday by the New York Times.

Last week, Sen. Herb Kohl (D., Wis.) announced he won an agreement to include a $275 million increase for the FDA in an emergency-spending bill for the wars in Iraq and Afghanistan.

"Given the inadequacy of the President''s budget for FDA, Congress must provide this immediate boost in funding for the agency so it may effectively fulfill the critical mission of protecting food and drug safety," Mr. Kohl wrote Wednesday.

Corinne Hirsch, a spokeswoman for the Office of Management and Budget, said the FDA''s budget has increased 81% during the Bush administration and believes the current budget will allow the agency to achieve its mission.

A Kohl spokesman said he believes other senators will support the increase.

The Senate Appropriations Committee is expected to approve the war-spending bill Thursday. The FDA funds were included in the measure to be presented to the committee, a spokesman for Sen. Kohl said.

The FDA''s foreign inspections have come under intense review in recent months following the contamination of heparin, a widely used blood thinner, that was shipped from plants in China. The tainted drug has been linked to 81 deaths.

In an April 29 hearing, FDA director Janet Woodcock was pinned down by House Democrats to reveal what resources the agency needed. She suggested $225 million but wouldn''t commit to that figure.

Sen. Specter wrote to Dr. von Eschenbach on May 1 seeking details on what the FDA needed to help police the drug and food industries. Dr. von Eschenbach said $125 million would be for food protection; $100 million for safer drugs, devices and biologics; and $50 million would go toward updating the FDA''s science and work force. The agency could use $20 million to boost its presence overseas, with the majority of that going toward opening two offices abroad.

According to a copy of the letter, Dr. von Eschenbach said the figures reflect his professional judgment and don''t reflect "competing priorities that the agency, the President, and their advisors must consider as budget submissions to the Congress are developed."

The boost in FDA resources Sen. Kohl included in the war-funding measure is in addition to a $150 million increase provided in the 2008 Agriculture Appropriations bill.

http://online.wsj.com/article/SB121080510568593153.html

Did You Know?

  • The FDA oversees 80 percent of the nation''s food supply, but only recieves 20 percent of food safety funding?
  • HACCP (Harzard Analysis and Critical Control Point) was originally developed for NASA to ensure the safety of food for consumption in space?
  • The FDA''s entire budget is actually less than the budget for the school system in Montgomory County, MD, where FDA resides?
  • Some in Congress would impose "User Fees" on Food Companies as a way to increase FDA''s budget. Such "fees" are really just new taxes on food and would undoubtedly be passed through to the consumer by way of higher food prices.
  • Current customs law already requires the importers of finished, packaged products, seafood, and some bulk foods to include country of origin labeling on the package. Beginning in 2008, fresh fruits and vegetables imported into the U.S. will also need to display their country of origin.