Beware of Childrens’ Medicine Makers

Last month, when the Food and Drug Administration recalled “40 kinds of [Johnson & Johnson] liquid pediatric Tylenol, Motrin, Benadryl and Zyrtec” because they possibly contained metal particles and/or ingredient problems, the FDA pointed worried parents straight to the generic brands found on most drug store shelves. But now, it turns out, a Michigan company – Perrigo – that supplies these generics to big drugstore chains (CVS, Walgreens), has its own possible “significant manufacturing violations” - including ibuprofen pills that are “contaminated with metal shavings.”

What''s going on here?  Hopefully, today Congress will start to find out when it holds a hearing on the Johnson & Johnson recall, where among other things the company will be asked whether it had reduced its quality control staff at its McNeil Consumer Healthcare unit.  According to the New York Times, McNeil's recent problems there have included “failure to investigate and take corrective action on consumer complaints regarding particle contamination in a drug, unclean equipment at the plant, failure to train employees in good manufacturing practices, and bacterial contamination of a drug ingredient.” Moreover, “McNeil shut down the plant after the inspection and recalled the liquid children’s products.”

Back to Perrigo. This company, says the FDA, shipped ibuprofen “contaminated with metal shavings.”  What’s more,  “In an earlier incident in 2006, Perrigo recalled about 11 million bottles of acetaminophen because it found metal particles, ranging from a speck to 8-millimeter pieces of wire, in some caplets.”

Which brings us back to Perrigo’s home base – Michigan.  When people ask “why are U.S. plants violating U.S. manufacturing standards?” we are reminded of Michigan’s way-too cushy relationship with the pharmaceutical industry.  As we’ve blogged many times before (here, here, here), Michigan is the only state in the nation that has made it impossible for its own residents to sue drug companies over FDA-regulated drugs that harm them.  Drug companies are immune there, no matter how many people are injured or killed.  Efforts to repeal this egregious law remain stalled.

I know this is beyond Congress’ jurisdiction, but a question or two about Michigan’s law at today’s hearing would sure be nice!

Comments

[Justice in Michigan]

Such a question would be nice, indeed, but it almost certainly won't happen.

What we need is getting out the word--even to many in Michigan who don't know about our odious law. But I'm not holding my breath for help from our Congressional folk.

Nor, in fact, have we had much help from our Governor or the majority of other state officials. Makes you kinda yearn for a tea party.