WAXMAN: DTC AD HIGHLIGHTS NEED FOR INVESTIGATION OF DECONGESTANTS' EFFECTIVENESS
A recent direct-to-consumer (DTC) ad may indicate that the new active ingredient in many nasal decongestants is no more effective than a placebo, highlighting the need for an FDA investigation, Rep. Henry Waxman (D-Calif.) says.
The agency needs to investigate whether phenylephrine is as effective as pseudoephedrine as the active ingredient in decongestants, Waxman said in an Oct. 23 letter. Waxman cited a new advertisement by Schering-Plough as evidence that the company's study of the two ingredients may have raised significant questions about the effectiveness of phenylephrine.
Schering bought television and newspaper ads touting its decision to continue selling its decongestant Claritin-D with pseudoephedrine as the active ingredient. Many other companies have switched the active ingredient in their decongestants to phenylephrine because a new law requires all drugs containing ingredients that can be used to make methamphetamines, including pseudoephedrine, to be sold behind the counter.
The agency had earlier rejected Waxman's request for an investigation. But the FDA left the door open for a review if more information became available.
Waxman believes the advertisement may serve as proof that a clinical trial conducted by Schering calls phenylephrine's effectiveness into question. "Schering's actions are unusual for a pharmaceutical company, and they suggest that the Schering study may have raised significant questions about the effectiveness of phenylephrine." If the agency does not take these steps, it calls into question whether the FDA is meeting its responsibilities to ensure drugs' safety and efficacy, he added.
Waxman also wants the agency to explain whether it has reviewed the Schering study and what the FDA makes of the results.
The FDA had no comment on the letter. The letter is available at www.democrats.reform.house.gov/Documents/20061023124055-63895.pdf (http://www.democrats.reform.house.gov/Documents/20061023124055-63895.pdf).