| This week, an FDA advisory panel found that the most common over-the-counter decongestant, phenylephrine, is no more effective than a placebo. Though it’s news for most of the country, experts say that the research on phenylephrine, which dates back more than 50 years, has never really shown otherwise. To figure out how such a medicine could stay in use for so long, I talked to Leslie Hendeles, half of a two-man team of allergists at the University of Florida whose two citizen petitions asking the FDA to expand and reevaluate the evidence on phenylephrine—one in 2007 and one in 2015—helped force the agency to have the difficult conversation to reconsider the drug. The answer is a combination of the slow churn of bureaucracy, the changing standards of science over time, and the power of market pressures. There are still a number of steps that must be taken before phenylephrine is pulled from pharmacy shelves, but even by considering the possibility, the FDA is still trying something new for the agency: revoking an approval based on efficacy alone rather than safety, the other key requirement. New legislation has recently made this option simpler than ever before, meaning that this could mark the start of a series of FDA decisions aimed at other medications that lack solid evidence (looking at you, Robitussin). It takes a big agency to admit when it’s wrong, but in the long run, but Americans deserve trust in remedies that work. READ MORE |
