FDA Will Overhaul Approval Process for OTC Drugs

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The Federal and Drug Administration is looking into a major revamp that is expected to affect consumers everywhere. Hint: it involves other-the-counter drugs. According to the Wall Street Journal, the FDA shared plans Friday that illuminates how it will evaluate and improve its current process for OTC medication approval. The overhaul will have ramifications for how tens of thousands of medicines and personal care items are processed and sold.

To reach U.S. store shelves, OTC products have long faced a time-consuming review process that not only takes them through several stages, but also keeps manufacturers from later having the opportunity to modify their products, even if better ingredients emerge. That keeps drugs from getting necessary upgrades, and potentially puts consumers’ health at risk, because many of the ingredients that are currently in medications are now outdated, or “have never been evaluated for safety and efficacy,” as Dr. Sidney M. Wolfe, founder of Public Citizen Health Research Group, points out.

The Wall Street Journal highlights the example of a 500-milligram over-the-counter Tylenol pill generically called acetaminophen. The FDA has approved it to be sold despite liver toxicity issues because under the current system, the drug’s ingredients are not allowed to be upgraded without going through the laborious approval process all over again. Dr. Wolfe says, via the Journal,  ”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,” and even the FDA reportedly admits that the highest over-the-counter Tylenol pill should be just 325 milligrams. However, the agency cannot change the current dose because the current regulatory framework doesn’t allow modifications to be made quickly.

That’s why, according to the Journal, the FDA is currently in the process of reviewing its system, and it hopes to overhaul the approval path that medications are currently subjected to. The agency plans to reformulate the new framework so that manufacturers can more easily introduce newer form of products quickly if researchers discover better ingredients. The FDA will hold a public hearing March 25 and 26 to hear the public’s feedback on its revision to the current approval framework that was first created in 1972.

Any changes are expected to have significant implications for the OTC medical products industry, considering the Journal reports that it recorded $29.3 billion in annual U.S. sales in 2012, and could see a different trajectory of sales moving forward. A quicker approval of new drugs could significantly boost OTC sales as more consumers take to the counter to buy the latest drugs; however, there is also expected to be a transition period where regulators will have to get used to a retirement of the old and a welcoming of the new.

Nonetheless, it’ll certainly be interesting to see what’s in store for the current system that bases itself off “monographs,” or recipes of ingredients that go into drugs. According to the Journal, the monograph approval system is different from the one that most prescription drugs get tested through, but with the overhaul, that new framework could show minimized differences. Many researchers, including Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation, have noted that they would like monograph drugs to follow the same approval process as prescription drugs do. The expected changes include giving the FDA the ability to quickly require new warnings or label changes for drugs as new science emerges, and hopefully allow the facilitation of innovations in products more fluidly. In addition, the FDA would like new dosing limits for children to solely be based on the most recent science, rather than past research.

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