New FDA rule on product liability may have no impact

There’s been a lot of speculation recently that the FDA would change a rule to preempt state prescription drug product liability laws. However, according to a health care policy note from Citigroup, the new product labeling rule –which does in fact assert that FDA approved labels preempt state laws– will have no effect.

According to Citigroup, the declaration is part of the rule’s preamble and so is not legally binding. It’s simply a restatement of existing FDA policy.

January 18, 2006

One thought on “New FDA rule on product liability may have no impact”

  1. I took zyprexa starting in 1996 the year the FDA approved it, which was ineffective for my condition and gave me diabetes.

    Zyprexa is the product name for Olanzapine,it is Lilly’s top selling drug.It was approved by the FDA in 1996 ,an ‘atypical’ antipsychotic a newer class of drugs without the motor side effects of the older Thorazine.Zyprexa has been linked to causing diabetes and pancreatitis.

    Zyprexa, which is used for the treatment of psychiatric disorders, such as schizophrenia and bipolar disorder, accounted for 32% of Eli Lilly’s $14.6 billion revenue last year.

    Did you know that Lilly made nearly $3 billion last year on diabetic meds, Actos,Humulin and Byetta?

    Yes! They sell a drug that can cause diabetes and then turn a profit on the drugs that treat the condition that they may have caused in the first place!

    I was prescribed Zyprexa from 1996 until 2000.
    In early 2000 i was shocked to have an A1C test result of 13.9 (normal is 4-6) I have no history of diabetes in my family.

    All the psychiatrist I’ve interviewed and the information on line presents zyprexa as a worse offender than the other Atypicals such as seroquel.My doctor has stopped prescribing zyprexa altogether.

    The PDR classifies zyprexa as ‘severe’ for causing weight gain and diabetes and seroquel as ‘moderate’.

    Of course the 50 year old Thorazine didn’t cause diabetes and is many times cheaper but it could cause tardive dyskinesia.

    Where Eli Lilly’s negligence comes in,is their KNOWING and not informing consumers (black box warning) until the FDA demanded it.

    Lilly’s incentive not to readily disclose is they had billion$ coming in from state medicaid scripts.
    —-
    Daniel Haszard http://www.zyprexa-victims.com

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