Avalanche of drugs, scarcely any oversight, II

communities to get this product available,” Parkinson said. “It’s not a matter of the financial significance of the product. It’s a matter of the role that it plays in medicine.”

While Baxter scrambles to find answers about heparin, a search for answers is under way on Capitol Hill, too. This search, though, is focused on assessing whether the FDA is applying strategies and resources capable of protecting American consumers in a day of a global supply chain. The House Subcommittee on Oversight and Investigations of the House Energy and Commerce Committee is scrutinizing the FDA’s oversight of the drug industry, and imports from China in particular. By law and as a matter of policy, the FDA is the first line of defense for drugs entering the United States. Critics say the agency’s financial resources and manpower have not kept up with the workload required to protect the public. The Science Board report paints a bleak picture: Even as the United States imported an estimated $72 billion in drugs and active ingredients in 2006, the FDA that year spent $12.75 million inspecting foreign production plants. Although drug imports have ballooned over the last five years, the amount spent on inspections fell slightly during that time. While some 3,250 non-U.S. plants were subject to FDA inspection last year, the agency has conducted only 1,445 foreign inspections in the last five years, according to a recent Government Accountability Office (GAO) study. That seems to leave the agency far short of a requirement that it inspect each plant every two years.

China syndrome

The FDA inspection shortfall is particularly acute in China. The FDA has averaged just fifteen inspections in China in each of the last five years. Yet China’s fast-growing industry now numbers 714 plants that ship drug products to the United States. At that rate, it would take the agency nearly forty-eight years to inspect each plant just once — and well more than that, if China’s booming 17 percent annual growth rate for drug exports is taken into account. By 2010 China is expected to produce nearly 25 percent of the world’s pharmaceutical ingredients, according to a recent study by the investment firm Credit Suisse. “If you haven’t been in a plant for the last two or three years, you don’t have any clue what’s going on in those places,” said a congressional source familiar with investigative work into the FDA by the House Commerce Committee’s subcommittee. “They could be running monster truck rallies on the plant floor, and we wouldn’t know about it.”

Baxter’s heparin troubles have also brought to light problems with the FDA’s data management systems. “The computer infrastructure is outdated, it’s not stable, there is insufficient security and capability,” said Dale Nordenberg, a Science Board member who specialized on the computer systems. “The FDA is still relying on an amalgamation of paper-based records and poorly integrated electronic platforms.” The two main FDA databases cannot agree on how many foreign companies are subject to FDA inspection. One claims the number is 3,000, the other, 6,800. Adding to the confusion, the FDA uses corporate names, rather than identification numbers, to track production plants and registration information. For an agency monitoring the operations of companies in dozens of countries worldwide, this creates confusion. Indeed, Scientific Protein’s China operation slipped through the FDA’s inspection regimen primarily because of confusion over the company’s name. Nordenberg is hardly encouraged by the agency’s admission this was at the root of the FDA’s failure to inspect the plant. “That’s just another error that they’re admitting to,” Nordenberg said.