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US stock market daily report (February 21, 2014, Friday)
The over-the-counter medical products industry - from pain relievers to personal care products - could face major implications as the Food and Drug Administration makes way for an overhaul of the approval process. For decades, over-the-counter products have been approved through a time-consuming process that hampers manufacturers' abilities to later modify their ingredients. The revamp by the FDA, will change the way tens of thousands of over-the-counter medicines and personal products reach store shelves in the USA.
Tens of thousands of drugs and products are created through 'monographs' - recipes of ingredients that go into drugs and products. The monograph process is distinct from the testing required by the FDA for prescription drugs. Dr. Janet Woodcock, director of the FDA's center for drug evaluation, said in an interview, "The current system isn't working well for the public or for us. We would like monograph drugs to have the same safety framework as prescription drugs."
The FDA said the current framework they use for over-the-counter medicines and personal products was created in 1972 but needs a complete revision to become a more agile and responsive process. A public hearing is scheduled by the FDA on March 25 and 26 to review feedback from the public. Woodcock said, "We want to get the word out that we're looking for creative ideas about how to improve the process."
According to the Consumer Healthcare Products Association, which represents the over-the-counter medical products industry, recorded nearly $29.3 billion in annual sales during 2012, in the USA. David Spangler, senior vice president for policy at CHPA, agrees with the need for a more efficient approval process. Spangler estimates there are over 100,000 over-the-counter medicines and personal products on the market today. He also said for years, the drug industry has wanted to put more detailed dosing on acetaminophen labels but that the FDA hasn't allowed it. "When they have the will, they're able to do it," he said.
Despite liver toxicity issues, the FDA allows a 500-milligram Tylenol pill to be sold over-the-counter - generically called acetaminophen. While the FDA agrees the highest over-the-counter Tylenol pill should only be 325-milligrams, current regulatory framework does not allow such changes to be made quickly. Maker of Tylenol Johnson & Johnson (JNJ-NYSE) said that "when used as directed, Tylenol has one of the most favorable safety profiles among OTC pain relievers."
The FDA is contemplating certain specific changes that it details in a Federal Register notice to be posted Friday. The changes include improving the FDA's ability to quickly require new warnings or label changes as safety issues emerge based on new science. The agency is hoping the overall will allow innovative changes in products more quickly. Additionally, the FDA wants to include new dosing limits for children based on the most recent science.
Dr. Sidney M. Wolfe, founder and senior adviser of Public Citizen Health Research Group in Washington, a consumer advocacy said, "It is inexcusably poor judgment on the part of the FDA to have failed to take action concerning this major source of acetaminophen consumption, and, consequently, acetaminophen toxicity." Wolfe said the current approval system from the FDA is so laborious that "there are ingredients on the market that have never been evaluated for safety and efficacy." Many ingredients were on the market before 1972 and monographs that would have covered them remain unfinished.
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