With the reclassification of pseudoephedrine as an over-the-counter product in 2005, oral phenylephrine became widely used as an over-the-counter nasal decongestant. Evidence that it doesn’t work. Randy Hutton, a clinical professor at the University of Florida College of Pharmacy, and his colleagues worked to bring the issue to the attention of the FDA. Uncovering loopholes in the old OTC drug regulatory process. Hutton wrote in an opinion piece in Scientific American: Before the FDA required proof of drug efficacy, it determined whether OTC drugs were effective through a panel of experts who reviewed existing data.these OTC Monograph Establishes what older OTC ingredients can be sold without FDA approval. An expert panel on oral decongestants reviewed several published studies and several unpublished studies on phenylephrine. Of the unpublished studies, only 4 studies Oral phenylephrine was shown to be effective in seven patients and was shown to be no different from placebo. We requested copies of all evidence used by the Nasal Decongestant Review Panel through a Freedom of Information Act request and conducted our own systematic review and meta-analysis. […]
The FDA has multiple regulatory processes for different types of drug compounds. Perhaps what people are most familiar with is New drug application process, which leads to clinical trials for prescription drug approval. However, many OTC or over-the-counter medications are regulated differently. In fact, a law passed in 1951, the Durham-Humphrey Amendments to the Food, Drug, and Cosmetic Act of 1938, created categories of prescription and nonprescription drugs. In 1962, the law was amended again to require well-conducted clinical trials to prove the effectiveness of drugs. So what happens to drugs approved before 1962? This is the loophole that some his OTC drugs fall into. Regarding prescription drugs, the FDA through his review of over 3,000 prescription drugs sought to address pre-1962 approvals. Although most of these drugs have now been reviewed and addressed, there are still unapproved prescription drugs on the market, such as extended-release oral nitroglycerin. For over-the-counter drugs, the FDA Established OTC monograph process It has been 10 years since the Food, Drug, and Cosmetic Act was revised in 1962, requiring the review of unproven products. The FDA established an advisory committee that groups hundreds of ingredients into 26 categories based on the product’s intended use. After collecting all available public and unpublished information from manufacturers, the advisory committee issued a final report to FDA regarding: These ingredients were GRASE (generally recognized as safe and effective), not GRASE, or inconclusive. GRASE ingredients can be used in over-the-counter drugs without FDA approval if the use is consistent with the monograph. “The example of oral phenylephrine shows that the FDA needs more funding to investigate these older drugs,” Hutton concludes. “Public funding is needed to support independent researchers who want to objectively examine these products.Governments are spending millions of dollars to save consumers billions on ineffective products. The companies selling these products have no incentive to prove they don’t work.”Drugs not only have to be safe, they have to be effective. ”