FDA to revamp rules on kids' cold meds

Remember all the brouhaha last fall about children's cold medicines? Well, the controversy is back. And this time the FDA says it's going to thoroughly review the safety and effectiveness of those products, revamping the criteria used to determine whether they should remain on the market. "Modern science has advanced...and this is an opportunity to apply modern science to evaluate these products," said Janet Woodcock, CDER director.

You could say that about any drug that's been on the market awhile, though. The reason these drugs are drawing scrutiny is that pediatricians have been lobbying for it, saying there's little evidence they help kids and lots of evidence that they can cause severe side effects. Plus, these products were approved back before pediatric drugs had to be tested in kids, so they never were.

Last year, the FDA convened an advisory panel to look at the meds, and in advance of that meeting, drugmakers voluntarily withdrew all over-the-counter cough and cold products for kids younger than 2. The panel itself recommended against their use in children younger than 6, and called for new studies to assess them when used in children. Now, the agency plans a hearing Oct. 2 to start figuring out what sorts of studies should be done and what other steps should be taken in the interim.

- read the article in the Washington Post

Suggested Articles

Post-Tesaro buyout, don’t expect GlaxoSmithKline to spring for more commercial-stage oncology products anytime soon.

Already a fast-growing blockbuster, Novo Nordisk's injectable Ozempic won a major heart-helping FDA nod that could bode well for its oral sibling.

Bayer's new Vitrakvi for tumors with NTRK gene fusions is meeting skepticism in England and Germany, where cost watchdogs on Friday rejected it.