Portfolio Media, New York (April 24, 2008) The U.S. Food and Drug Administration is not currently able to handle the demands of regulating an increasingly global pharmaceutical supply chain, Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, told a Senate panel Thursday.

The FDA has traditionally been configured as an agency to regulate a domestic industry," Woodcock said. "The FDA of the last century is not configured to regulate this century's globalized pharmaceutical manufacturing industry."

At a hearing before the Senate Committee on Health, Education Labor and Pensions, senators sought to examine FDA weaknesses exposed by the recent scare over Baxter International Inc.'s blood thinner heparin, which was removed from the market in early February after being linked to several deaths and allergic reactions.

The active ingredient in the drug was made in a Chinese factory, and the FDA revealed new evidence this week that links the reactions to a man-made contaminant that was introduced during production in China.

As seen in the heparin incident, intermediates and products can now move in a globalized world through a complicated web of distribution," Woodcock said. "This supply chain is not manageable by our traditional methods."

Pharmaceutical production has evolved rapidly, with the manufacturing of active pharmaceutical ingredients now largely outsourced to other countries, and the agency's pharmaceutical inspection resources have decreased over the years, Woodcock said.

“We do not inspect the facilities oversees very much at all,” Woodcock said.

The agency needs a dedicated foreign inspector corps, something the agency now lacks, Woodcock said.

While acknowledge significant problems at the FDA, Woodcock argued that boosting the power of the agency is only part of the answer. Players throughout the supply chain must be held accountable for ensuring quality, Woodcock said.

“The FDA or any other worldwide regulator cannot test quality into products,” Woodcock said.

The FDA's top priority is to develop an inventory of manufacturers that are importing pharmaceutical ingredients and products into the United States in order to better be able to verify what is being brought into the country and what should be permitted, she said.

William K. Hubbard, a former associate commissioner for FDA policy and planning, told the Senate panel Thursday that the United States has built an impressive safety net in the FDA, but it has not given regulators the means to regulate drugs from abroad at time when 80% of the nation's pharmaceuticals are imports, either in finished pharmaceuticals or raw materials.

"I think we're at great risk because essentially we have a largely unregulated supply in some cases," said Hubbard, who suggested that the FDA's problems mean the heparin scare could easily happen again.

Still, Gerald Migliaccio, vice president of quality for Pfizer Inc., told senators Thursday that pharmaceutical companies have a vested interested in ensuring that safety standards are met at each stop on the supply chain.

“If we have recalls or deaths because of contaminated products, it is our reputation,” Migliaccio said. “We have standards. And we insist that contractors achieve those standards.”

Migliaccio, who argued that responsibility for pharmaceutical safety is shared by the drug industry and the FDA, noted that Pfizer has quality monitors in countries around the world to check that manufacturers of key pharmaceutical ingredients are adhering to the company's standards.