Tuesday, September 21, 2010

a bit of light reading - sample anno.

You do the crime. You pay the time. Or in this case the fine. 

Forest Pharmaceuticals is facing over $300 million dollars in fines and penalties for undermining the rules and regulations of the Food and Drug Administration. From distribution of an unapproved drug to the misbranding of medication Forest is currently under immense scrutiny.

The drug that started this witch hunt was Levothroid, or levothyroxine, an unapproved drug used to treat hypothyroidism. Levothroid by Forest actually has a long standing history to before 1997. At the start of 97' the FDA enacted a new policy that would require the drug to be re-approved if the manufacturer intended on continuing the marketing of the product. However, because Levothroid was labeled a necessary drug, the FDA allow temporary use of the drug until it was phased out which was to occur before August of 2003. But like any normal human being financial gain obscured their judgement. Forest Pharm did not begin phasing out their drug, instead they increased production. 

Celexa was the second mistake Forest had to own up to. Used as a serotonin reuptake inhibitor for adults, Forest began branding the drug for the pediatric units in hospitals. The promotion of Celexa for children has not be approved by the FDA and therefore Forest was charged with an additional count of misbranding medication.

You may ask what took the FDA so long to crack down on Forest's misconduct. Well, according to the 2003 FDA inspection Forest employees provided false statements regarding Levothroid and Celexa. And as a result Forest is now charged with their last count of impeding an agency proceeding. 

In total Forest Pharmaceuticals, and their mother company, Forest Laboratories, will be paying a $164 million dollars in criminal penalties and an additional $149 million dollars to relieve a civil suit with the Office of Inspector General of the U.S. Department of Health and Human Services. 

If you're worried about all the people currently on Levothroid, there's no need. The FDA would never let an unapproved drug sit on the market to wait the outcome of a court case. The Levothroid currently under scrutiny was yanked off the shelves and re-submitted for FDA approval which is eventually received. It is now compliant with FDA regulations. 

Its reassuring to know the FDA has a system that requires even large corporate companies to follow. And luckily the drug was caught early enough to prevent fatalities. If patients had died, Forest would be facing more than just a few million dollars in fines. 


1 comment:

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