FDA Opens Review of Rules for Over-the-Counter Drugs, Including Acetaminophen - ProPublica

FDA Opens Review of Rules for Over-the-Counter Drugs, Including Acetaminophen - ProPublica:

The U.S. Food and Drug Administration has launched a review of the way it ensures the safety and use of over-the-counter drugs taken by hundreds of millions of Americans, opening the door to the most significant reform in four decades.The agency’s announcement follows a ProPublica investigation last fall focusing on acetaminophen, the active ingredient in Tylenol, which is among the drugs that would fall within the review.As we reported, despite more than 40 years of work, the FDA has yet to finalize rules governing the safe use of acetaminophen, hobbled, in part, by the cumbersome and bureaucratic system for regulating non-prescription drugs.Acetaminophen can cause liver damage and death in amounts close to the current recommended daily limit. Our investigation found that about 150 people die each year from accidentally taking too much of the drug. Tens of thousands of others are rushed to the emergency room or hospitalized.FDA officials have complained that the system in place since the early 1970s, known as the monograph process, is too slow to adjust to emerging safety issues.“When we look at how rapidly science now evolves and the impact this has had on the emergence of drug safety issues and on drug development, it is clear to that  a more agile and responsive process” is needed for over-the –counter drugs, the agency said in a response to questions.Our investigation showed that such delays have sometimes carried a high cost. The agency spent at least 15 years arguing with Tylenol’s manufacturer, Johnson and Johnson unit McNeil Consumer Healthcare, on how to improve the safety of pediatric acetaminophen. During that time, some 20 children died after their parents accidentally gave them overdoses of the medicine.In contrast, the prescription drug system allows the agency to make relatively quick changes to warning labels or dosage instructions. For instance, the FDA recentlyannounced that prescription medications containing acetaminophen could contain no more than 325 milligrams of the drug, citing the potential health risk.But consumers can still buy pills with twice that amount of acetaminophen over the counter at drug stores and supermarkets because the monograph system requires lengthy periods of debate and public comment.The FDA announcement reaches far beyond acetaminophen...........

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