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Finally a Deal in Place for Inspecting Foreign Drugs


The following is based on an article published in the New York Times.


At its present pace, the FDA would need more than 13 years to inspect every foreign drug plant exporting to the US. Some plants have never been inspected, which saves them huge sums in cleanup and other compliance costs – an important reason that drug manufacturing is disappearing from the US and that tainted-drug scandals occur.


In one infamous case, Chinese manufacturers deliberately substituted a cheap fake for the dried pig intestines used to make the blood-thinning drug heparin. The tainted drug was linked to 81 deaths and exposed tens of thousands of people to danger. The FDA had never inspected the plants making the crucial ingredients, a larger problem that only now, more than three years later, may be fixed.


After decades of failed attempts, the federal government and the generic drug industry have reached an agreement that is almost certain to pass Congress and that will lead to routine inspections of these overseas plants, potentially transforming the enormous global medicine trade. Under the landmark agreement, expected to be completed within weeks, generic drug companies – which make 75% of the prescription medicines sold in the United States – would pay $299 million in annual fees to underwrite inspections of foreign manufacturing plants every two years, the same frequency required of domestic plants. Self-interest helped drive the agreement because the industry will not only get speedier approvals of new products as part of the deal but also may avoid scandals involving tainted medicines, which tend to hurt confidence in the entire industry.


Dr. Margaret Hamburg, commissioner of the F.D.A., said she was pleased with the generic drug fee proposals. “If a program along the lines of what the parties are working on is enacted by Congress, it would represent a real breakthrough,” Dr. Hamburg said. “FDA’s entire generic drug program would be placed on a much more stable footing.”


The agreement will not affect the making of over-the-counter medicines or vitamins, whose global supply chains are even more vulnerable to tampering since government inspectors almost never visit their makers. Aspirin and vitamin C supplements, among others, are now made almost entirely in uninspected plants in China. Nor will the agreement change the FDA’s oversight of name-brand prescription medicines. Although branded drugs usually have more secure supply chains than those of generics, major pharmaceutical companies have moved aggressively into China in recent years and often rely on rarely inspected suppliers.


Federal officials for years have expressed concerns about the nation’s growing reliance on sometimes mysterious foreign drug suppliers, but they had largely despaired of fixing the problem. Congress has never given the FDA the money needed to inspect these plants, and for nearly two decades the generic drug industry resisted proposals to pay inspection fees. The industry changed its stance for several reasons. First, the heparin scandal scared everyone. The fake ingredient was good enough to pass a sophisticated test, so the conspirators probably knew that deaths would result, reflecting a callous level of greed. And the Chinese government refused to allow the FDA to investigate, suggesting that the perpetrators were not only smart but politically well connected. Second, the generic drug industry is no longer a motley collection of struggling mom-and-pop companies. Years of consolidation have created giants like Israel-based Teva Pharmaceuticals that understand that their businesses depend on winning the confidence of patients and regulators alike, and they can afford to pay the fees needed to achieve that confidence.



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