Healthy Skepticism Library item: 7276

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Perrone M.
Waxman Asks FDA to Examine Claritin Study: Waxman Asks FDA to Investigate Effectiveness of Over-The-Counter Decongestant Ingredients
Yahoo Finance 2006 Oct 23
http://biz.yahoo.com/ap/061023/fda_schering.html?.v=1

Abstract:

An influential congressman wants regulators to find out why Schering-Plough Corp. decided to keep the key ingredient in its best-selling decongestant Claritin-D the same even as rivals switched the main ingredient in theirs.
An Oct. 23 letter Rep. Henry Waxman (D-Calif.) wrote to the Food and Drug Administration asks the agency to investigate whether the main ingredient being used by some makers of over-the-counter cold medicines might be ineffective.

It was the third letter Waxman has sent to regulators since a federal law was passed earlier this year, requiring pharmacies to keep cold medicines which contain pseudoephedrine in locked cabinets. The law is designed to discourage the illegal processing of cold medications into the widely abused stimulant methamphetamine.

Concerns over potential sales losses prompted some drug makers to look for formulas that could still be sold from open shelves. Johnson & Johnson, for example, changed the key ingredient of its over-the-counter decongestant to phenylephrine from pseudoephedrine.

Waxman’s Oct. 23 letter to the FDA suggests that Schering-Plough’s decision to keep its ingredient the same — even if it means lower sales — was based on an internal company study showing that phenylephrine is ineffective.

Waxman, ranking Democrat on the House Committee on Government Reform, asks the FDA to obtain the results of the company’s study for review.

Schering-Plough declined comment on the study. The FDA and J&J did not immediately respond to calls for comment.

Shares of Schering-Plough were down 12 cents Monday to $22.71 following a previous close of $22.83 on the New York Stock Exchange. Shares of J&J rose 48 cents to close at $69.10, also on the NYSE.