Washington Editor

WASHINGTON - The Senate Friday passed an amendment to the $3 trillion fiscal year budget resolution to increase the Bush administration's request for the FDA's budget by $71 million, bringing the total allocation to $375 million for 2009.

Sen. Edward Kennedy (D-Mass.), chairman of the Health, Education, Labor and Pensions Committee, called the Senate's action a "big first step toward rebuilding the FDA."

The Senate's proposed increase meets the amount recommended by the FDA Science Board, which issued a scathing report in December about the agency's inability to fulfill its mission of protecting the public health. (See BioWorld Today, Dec. 3, 2007.)

The FDA budget amendment, known as #4148, must get through the House and be signed by the president before becoming law, which may be difficult in the current economic environment.

The Senate's move comes on the heels of the FDA's latest safety crisis involving contaminated heparin, which has been linked to manufacturing sites in China.

The FDA on Feb. 11 alerted the public about a spike in the number of serious adverse events associated with Baxter International Inc.'s blood-thinning agent heparin. The Deerfield, Ill.-based firm halted the manufacturing of multidose vials of the drug and recalled its products in the U.S.

The FDA Friday said that 20 of the 28 batches of the active pharmaceutical ingredients it tested from a Chinese plant contained a contaminant, which the agency is calling a heparin-like substance.

Officials said they are close to identifying what that substance is.

The agency has received nearly 800 reports of allergic-type adverse reactions related to heparin use since January 2007, regulators told reporters. There have been 21 suspected deaths linked to contaminated heparin, officials added.

In an effort to ensure the safety of products imported from China, the Department of Health and Human Services in December signed a memorandum of understanding with the Chinese government.

Under the agreement, Chinese authorities pledged to provide timely notification to U.S. regulators under a wide range of circumstances, including the failure of a facility to meet inspection requirements and the suspension or revocation of a manufacturer's certification status.

Yet two months later, the FDA again was warning the public about another safety failure involving Chinese-made products.

When Americans are prescribed a drug, Kennedy declared in a statement, "they shouldn't have to worry that a contaminant in the drug might kill them. They ought to be able to count on FDA to stand guard for them, use the latest and best science to protect them, and to do what's needed to detect dangerous products."

Drug regulators said they plan to place eight new safety inspectors in China and hire five Chinese nationals to work at diplomatic posts in that nation, pending approval by the Chinese authorities, to improve the safety of products exported to the U.S.

"In an age when a border is not a barrier, the globalized economy demands nothing less than heightened regulatory interoperability, information exchange and cooperation, especially on product quality and enforcement matters," Murray M. Lumpkin, the FDA's deputy commissioner for international and special programs, said in a statement.

The permanent overseas offices in China, Lumpkin said, will allow greater access for inspections and greater interactions with manufacturers to help ensure that products exported to the U.S. meet this nation's standards for safety and manufacturing quality.

U.S. imports reached more than 6 million shipments, worth $80 billion, in 2000, with that figure continually rising, regulators noted.

The FDA said it lacks the resources to inspect a "meaningful proportion" of imported products that arrive at more than 150 U.S. ports of entry.

Although FDA inspectors review all entry documents, they only physically inspect less than 1 percent of all imports, regulators acknowledged.

The agency came under fire by lawmakers and consumer groups after it was revealed last month that regulators failed to inspect the Chinese plant where heparin's active pharmaceutical ingredient is made. The FDA blamed the failure on a clerical error.

Reps. John D. Dingell (D-Mich.), chairman of the House Committee on Energy and Commerce, and Bart Stupak (D-Mich.), chairman of the Subcommittee on Oversight and Investigations, are considering "emergency" legislation to force the FDA to conduct preapproval inspections of manufacturing facilities. (See BioWorld Today, Feb. 25, 2008.)

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