FDA's lax approach to foreign drug safety endangers Americans

BALTIMORE, Md. — Talk about closing the barn door years after the rustlers have made off with your horses!

U.S. Food and Drug Administration Commissioner Margaret Hamburg returned last month from her first official trip to India seeking to convince the Indian government to begin inspecting thousands of plants that manufacture prescription drugs marketed in the United States. Hold the applause. It took Hamburg, a member of the Obama Administration's Chicago circle, five years to discover that many foreign pharmaceutical manufacturers don’t meet U.S. standards. Most Americans don't realize that the number of drug products manufactured outside the United States has doubled between 2001 and 2008. Nearly 40 percent of all drugs taken by Americans come from overseas, and nearly 80 percent of the active pharmaceutical ingredients used to make these drugs also come from foreign countries — mainly India and China. In India alone, there are 4,655 pharmaceutical manufacturing plants, employing over 345,000 workers. Their exports to the U.S. alone are estimated to be worth more than $50 billion. Over the past five years grave concerns have arisen about the safety of drug imports from China, India and other Asian nations whose manufacturing process fails to meet U.S. standards. Yet Hamburg waited until this February to meet with Indian government officials to request that they bring their pharmaceutical safety standards up to U.S. safety standards.

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Here's what Dr. Hamburg herself said in an interview with The New York Times last month: "The problems encountered by FDA investigators in India are similar to those seen around the world in manufacturing. "These include inadequate or poor quality systems implementation, data integrity issues, inadequate validation of various processes used in manufacturing or testing and product adulteration or contamination." But despite her dire assessment, she has been remarkably slow in taking action against out-of-compliance foreign drug manufacturers. It wasn't until early March, that the FDA finally took action against one Indian drug maker, citing non-compliance with regulatory standards to bar imports from four Ranbaxy Laboratories plants in India. Hamburg has stopped shipments only from the Ranbaxy plants while ignoring dozens of other foreign assembly lines of prescription drug plants that don’t meet U.S. standards. Instead, Hamburg returned from India and announced that staff from FDA's offices in Mumbai and New Delhi will work closely with suspect Indian companies to identify the problems and "take the necessary steps to self-correct them in 2014." In the meantime, hundreds of overseas drug countries may continue shipping pharmaceutical products to the U.S. that don’t meet our once high standards. Her failure to move swiftly should be frightening to the 70 percent of Americans — some 220 million plus — who now rely on prescription drugs, according to a recent study by the Mayo Clinic. This sad story plays out against a backdrop of a wholesale decline in pharmaceutical manufacturing facilities in America. Until the early part of this century, U.S. drug giants like Johnson & Johnson, Pfizer, Abbot, Merck & Co and Eli Lilly — through their powerful Washington, D.C. trade association PHARMA — lobbied hard to shut off the flow of imported drugs into this country. Citing safety as their main concern, they argued that imported drugs were made under lower standards and could well be contaminated. PHARMA's members made a major about-face in the early 2000's when they realized they could maximize profits by relying on low-cost foreign manufacturers. One major problem: many of the overseas factories remain unsafe. Where is the call for immediate action to remedy such a dangerous situation? More germane, why is someone with such a lackadaisical approach to consumer protection still in charge at America's most important health agency?