| There is a phenomenal article in Scientific American talking about the phenylephrine/pseudoephedrine debacle: https://www.scientificamerican.com/article/how-two-pharmacis... It's sort of a different class of failure than with opioids, but it is a notable area of weakness. Basically, for OTC drugs that were initially approved before 1962, many are still on the market despite sometimes having weak efficacy data. While the FDA has been making some progress in reevaluating these older drugs, we're still far from where we should be. A few quotes from the conclusion of the article (but the entire piece I linked in SA is worth a read!): > In 2023, 16 external experts on the second Nonprescription Drug Advisory Committee looked at all the evidence compiled by FDA staff, heard manufacturers' arguments in favor of oral phenylephrine's efficacy, and heard from experts like me who argued that oral phenylephrine is ineffective. In the end, they concluded that oral phenylephrine is not GRASE. A final ruling on whether decongestants containing the drug can still be sold will take time. We hope science will prevail. > From this experience we've learned that the monograph process for OTC drugs approved before 1962 needs to be reexamined. Systematic reviews of the available evidence indicate that other nonprescription drugs such as guaifenesin (sold in Mucinex and Robitussin), dextromethorphan (sold in Robitussin DM) and antihistamines marketed for colds (for instance, chlorpheniramine) probably don't help with coughs and colds. They are usually not dangerous, but their effects are likely to be the result of a placebo response; more modern research is needed. > The outcome for oral phenylephrine shows that the FDA needs more funding to look at old drugs. 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. |