Posts Tagged ‘ Children’s Motrin ’

Children’s Motrin: Another Example of a Toothless FDA

September 24th, 2010. By Hunter West

A controversy emerged this week over an alleged agreement between the US Food and Drug Administration (FDA) and Johnson & Johnson subsidiary McNeil HealthCare over a ‘soft’ recall of Children’s Motrin and other products that were thought to be defective due to lax GMP (Good Manufacturing Practice) at one of McNeil’s facilities. 

The allegation, if true, suggests that one arm of the FDA doesn’t know what the other is doing. It also appears to suggest—again—that so long as the FDA does not have the mandate to force a drug company to conduct a recall, or do anything it doesn’t want to, for that matter, the federal drug regulator is like a tiger without teeth. 

As for the drug companies, it appears as if they subscribe to the credo, “don’t ask permission, beg forgiveness.” 

According to documents and testimony at a congressional hearing this week, the FDA had decided that Motrin product, which had been identified as defective due to GMP problems at the facility where it was manufactured, should be subject to a Class 2 recall. 

There are various levels of recall identified by the FDA, with a Class 1 as the most serious. The latter is urged if there is a problem that could lead to serious health effects or even death. Class 2 is suggested if the problem could cause temporary, or medically reversible adverse health consequences. 

Further, a Class 3 is issued if a product defect is not likely to cause serous health consequences at all. 

Then there’s the ‘market withdrawal,’ which according to CNN Money on Tuesday is not a recall Read the rest of this entry »

Tags: Children's Motrin, FDA, J&J, Johnson & Johnson, McNeil
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