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Lawmaker Questions Drug's Effectiveness

 

28-Aug-2006: WASHINGTON (AP) - The ranking Democratic congressman on the House Committee on Government Reform, which oversees the Food and Drug Administration, has asked the agency to investigate whether the active ingredient being used in over-the-counter cold medications is effective in relieving nasal decongestion.

Manufacturers, including Sudafed-maker Pfizer Inc., switched to phenylephrine from pseudoephedrine the past year after passage of a law requiring all pseudoephedrine products be sold from behind pharmacy counters.

The law, which takes effect Sept. 30, is aimed at discouraging the illegal processing of cold medications into the widely abused stimulant methamphetamine.

Drugmakers began using phenylephrine so they could continue to sell cold medications in open aisles at retail pharmacies.

In an Aug. 23 letter to the FDA, Rep. Henry Waxman (D-Calif.) asks the FDA to review whether the drug phenylephrine is comparable to the previously used drug pseudoephedrine.

He cites a "letter-to-the-editor" published in the July issue of the Journal of Allergy and Clinical Immunology from two University of Florida professors who cite research that they say shows the ingredient now being used in Sudafed and other over-the-counter cold pills does not adequately enter the bloodstream to relieve nasal congestion.

Waxman requests that the FDA convene a panel of experts to consider whether a higher dosage of phenylephrine, originally approved by the agency 30 years ago, would be more effective.

A spokesperson for Pfizer said consumers have embraced the new version of Sudafed since its launch in February 2005.

"It's been well received in the marketplace and that would indicate that people are getting the relief they seek when they use this product," said spokesperson Erica Johnson.

Other products that switched to the new drug include Johnson & Johnson's Tylenol Cold Cool Burst tablets, along with dozens of generic brands.

The FDA did not return repeated phone calls seeking comment.

Shares of Pfizer rose 31 cents Monday to close at $27.54, while shares of Johnson & Johnson fell 9 cents to close at $64.58, both on the New York Stock Exchange.

Source: MSN Money