Cold medicine cleanup started by federal health officials

Cold medicine cleanup started by federal health officials

Cold medicine that has been available through prescription for years without approval by the Food and Drug Administration will be withdrawn, health officials say. These drugs have been there before FDA regulations were in place and the agency let them be sold until now.

The FDA said all prescription drugs should be subject under scientific review. Only then should they be allowed to be available again if the FDA determines their effectiveness and safety.

Cough and cold medicine as well as some allergy medication are covered by the order. Over the counter cold medication are not affected.

"We don't expect today's action to have a negative impact on consumers," said Deborah Autor, director of the FDA's Office of Compliance. "There are multiple other products available to treat cold, cough and allergy symptoms."

Health officials warned companies that have yet to register their medications with the FDA that they should stop manufacturing and selling their products. They also said these older drugs have labels similar to newer cold medicine that have been approved by the agency.

The FDA was given the mandate to scrutinize the effectiveness of new drugs in 1962. By that time many medications were already in the market and were just grandfathered under earlier rules.

Since 2006, dozens of companies have been hit for making and distributing unapproved medication. The FDA typically shuts down their production and confiscates products worth millions of dollars. But fines are not imposed under federal law. The latest crackdown is concentrated on unapproved cough medicine.

Posted by George Daniels on Thursday March 03 2011, 4:10 AM EST. Ref: AP. All trademarks acknowledged. Filed under Featured News, Health. Comments and Trackbacks closed. Follow responses: RSS 2.0