How Two Pharmacists Figured Out That Decongestants Don't Work

In 2005, the reclassification of pseudoephedrine to behind-the-counter status led to widespread use of oral phenylephrine in OTC decongestants, despite evidence of its ineffectiveness. Randy Hatton, a clinical professor in the College of Pharmacy at the University of Florida, and his colleague worked to bring this issue to the FDA's attention, revealing loopholes in the regulatory process for older OTC drugs. Hatton writes in an opinion piece for Scientific American: Before the FDA required that drugs had to be proven effective, it determined whether OTC drugs were effective through expert panels that reviewed existing data. These OTC monographs establish what older OTC ingredients can be marketed without FDA approval. The oral decongestant monograph panel reviewed a few published studies and multiple unpublished studies for phenylephrine. Of the unpublished studies, only four studies showed oral phenylephrine was effective, while seven showed it was no better than placebo. We requested copies of all evidence used by the nasal decongestant review panel via a Freedom of Information Act request and performed a systematic review and meta-analysis ourselves. [...] The FDA has multiple regulatory processes for different types of medicinal compounds. People are perhaps most familiar with the New Drug Application process, which leads to clinical trials for prescription drug approvals. However, many OTC or nonprescription drugs are regulated differently. In fact, a law passed in 1951, the Durham-Humphrey Amendment to the 1938 Food, Drug, and Cosmetic Act, created the categories of prescription and nonprescription drugs. In 1962, the act was amended again so that drugs had to be shown to be effective, hence the requirement for well-done clinical trials. But what about the drugs that were approved before 1962? This is the loophole that some OTC drugs fall through. For prescription drugs, FDA tried to address pre-1962 approvals through a review of over 3,000 prescription drugs. Most of those drugs have now been reviewed and addressed, but there are still unapproved prescription drugs on the market today, such as an extended-release form of oral nitroglycerin. For nonprescription drugs, FDA established the OTC monograph process 10 years after the 1962 amendment to the Food, Drug, and Cosmetic Act, which required products not proven effective to be reconsidered. FDA formed advisory panels grouping hundreds of ingredients into 26 categories based on the products' uses. After gathering all available information, both published and unpublished, from manufacturers, the advisory panels issued final reports to FDA about whether these ingredients were GRASE (generally recognized as safe and effective), not GRASE, or inconclusive. GRASE ingredients can be used in nonprescription drugs without FDA approval if the use matches the monograph. "The oral phenylephrine example shows that FDA needs more funding to look at these old drugs," concludes Hatton. "We need public funds to support independent researchers who want to examine these products objectively. The government should be able to spend millions to save consumers billions on ineffective products. Companies that market these products have no incentive to prove they don't work. Nonprescription drugs must be effective -- not just safe."

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