Fatal drug contamination like a 2008 incident involving Baxter International Inc.’s blood thinner Heparin that sickened and killed hundreds is inevitable unless the agency gets enhanced inspection and recall powers for non-U.S. factories, a top regulator said.
Another crisis is “not a matter of if, it’s a matter of when,” Deborah Autor, the Food and Drug Administration’s deputy commissioner for global regulatory operations and policy, told a U.S. Senate committee today.
The agency is asking Congress for power to compel drugmakers to recall risky medicines and institute a track-and-trace system that could follow treatments from manufacturer to shelf. Forty percent of drugs Americans take are made outside the U.S. and 80 percent of active ingredients in pharmaceuticals come from beyond national borders, FDA Commissioner Margaret Hamburg told the panel on July 28.
Autor also held up at today’s hearing a counterfeit version of New York-based Pfizer Inc.’s cholesterol-fighting drug Lipitor, and said that $20 million worth of the copies were dispensed to patients in 2003.
Senator Michael Enzi of Wyoming, the senior Republican on the Senate Health, Education, Labor and Pensions Committee, called the agency’s ideas “politically dramatic” and an “overreach.” Senator Tom Harkin, an Iowa Democrat who chairs the committee, has pledged a bipartisan bill that will help the FDA secure the drugs that come into the U.S.
“Right now my concern is FDA over-regulating, not FDA under-regulating,” Enzi said.
Mandatory Recall Power
The FDA has mandatory recall power for medical devices and has only used its power three times, Enzi said. He also said a track system, at $110,000 for an independent pharmacy, would be too expensive to expect a small business to buy when most counterfeits come from Internet purchases.
The China-made contaminated Heparin from Deerfield, Illinois-based Baxter spotlighted how the FDA inspects foreign plants less than those of domestic drug manufacturers. Without resources to inspect every non-U.S. plant, the FDA has said Congress should give the agency the ability to refuse products at the border when a maker declines an inspection.
“Because counterfeiting is a global problem requiring a global solution, Pfizer partners with regulatory, law enforcement and customs agencies around the world to help ensure patients have access to authentic, safe and effective medicines,” said Raul Damas, a spokesman for Pfizer.
Protecting the security of the drug supply “is a top priority,” said Karl Uhlendorf, vice president at the Pharmaceutical Research and Manufacturers of America, the industry’s lobbying group in Washington.
Laureen Cassidy, a Baxter spokeswoman, declined to comment because she said she hadn’t heard Autor’s comments.
Hamburg in July appointed Autor to her newly created position. The FDA also released a report outlining how the agency will attempt to increase its ability to handle a global pharmaceutical supply, including expanding its collaboration with foreign counterparts.
The FDA inspected 424 non-U.S. drug establishments, or 11 percent, in fiscal 2009, the Government Accountability Office found a year ago. The investigative arm of Congress estimated at that rate it would take the FDA nine years to inspect each foreign establishment once. The agency examines domestic firms about once every 2 1/2 years.
Enzi said the FDA should be able to target plants for inspections based on risk, regardless of location, to help level the playing field. Harkin said he’s leaning toward the idea, and asked whether drugmakers should pay a fee to fund inspections.
The 2009 numbers are an improvement over fiscal years 2007 and 2008 when the FDA inspected 333 and 324 foreign plants respectively, according to the Government Accountability Office.
China has the most establishments in the FDA’s inventory, 920 in fiscal 2011, according to the office, followed by India with 502, Canada with 310 and Germany with 228.