A front-page New York Times story reported, “More than 80 percent of the active ingredients for drugs sold in the United States are made abroad,” often in rarely inspected plants in China or India. “But 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.” Under the deal, expected to be finalized within weeks, generic drug makers would pay $299 million in fees annually to underwrite biennial inspections of foreign plants. The deal will also bring faster approval of new products and help avoid recurrence of past scandals with tainted or bogus drug ingredients. FDA Commissioner Dr. Margaret Hamburg said that the deal, if enacted by Congress, “would represent a real breakthrough.” The generic maker fees will be part of a broader package the administration is expected to send Congress in January.
Here are a few more excerpts from the article:
More than 80 percent of the active ingredients for drugs sold in the United States are made abroad, mostly in a shadowy network of facilities in China and India that are rarely visited by government inspectors, who sometimes cannot even find the 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.
At its present pace, the Food and Drug Administration would need more than 13 years to inspect every foreign drug plant exporting to the United States. 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 United States 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 F.D.A. never inspected the plants making the crucial ingredients, a larger problem that only now, more than three years later, may be fixed.
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 F.D.A.’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 F.D.A. the money needed to inspect these plants, and for nearly two decades the generic drug industry resisted proposals to pay inspection fees.