Based on a New Study, Rep. Waxman Renews Request for FDA Investigation of Phenylephrine Decongestants

Friday, September 22, 2006 - 12:56pm

Citing a study conducted and completed in 2006, Rep. Waxman renews his request that FDA investigate whether pheylepherine oral nasal decongestants are effective. Manufacturers have begun to offer alternatives that eliminate pseudoephedrine and relay instead on phenylephrine, which permits them to be sold over-the-counter without any restrictions.

In its response to Rep. Waxman’s August 23, 2006 letter, FDA refused to call an advisory committee to explore the adequacy of evidence showing that phenylephrine at the FDA monograph dose actually works. In his September 22, 206 letter, Rep. Waxman urges FDA to obtain and release data from a recently conducted clinical trial of phenylephrine and reconsider its decision.

109th Congress