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Author: Brenda Fulmer

Congressional Hearing on Proposed FDA Rule Change

04/2/2014
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Yesterday afternoon, Congress’s Subcommittee on Health held a hearing to examine the FDA’s proposal to change the rules of generic drug labeling. Under the current law, enacted in 1984, warning labels for particular drug formulations are created by the brand-name manufacturers, and generic manufacturers are legally prevented from altering them. […]

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When Money Influences Medicine

03/27/2014
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The Wall Street Journal reports on conflict of interest disclosures that have evolved as a result of transvaginal mesh (TVM) lawsuits filed against healthcare giant, Ethicon, a division of Johnson & Johnson. Amid the hundreds of thousands of pages of documents provided in the 17,000 cases filed in federal court […]

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J&J Gets $1.2 Billion Pass on Risperdal Fine

03/27/2014
Defective Drugs
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Two years ago, healthcare giant Johnson & Johnson was facing a $1.2 billion judgment after a jury determined J&J concealed the risks of its antipsychotic drug Risperdal while it aggressively and improperly marketed it off-label. At the time it was the largest state fine over the mismarketing of Risperdal and […]

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Compounding Problems

03/18/2014
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In the production of pharmaceutical drugs there are large scale drug manufacturers which produce brand name and generic drugs, and there are compound pharmacies which are specialty pharmacies made to fill out unique orders for clients using already existing medications. Drug manufacturers fall under FDA standards and regulations, while compounding […]

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Proposed FDA Label Changes Irking Generic Drugmakers

03/10/2014
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Generic drugmakers are increasingly becoming more frightened of the threat of products liability lawsuits because of a proposed rule that would require them to change their labels if the company receives new safety information about the drug. These label changes would overturn a three decade old regime of prohibiting generic […]

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Study Suggests Paxil’s Link to Breast Cancer

03/4/2014
Defective Drugs
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Paxil (paroxetine) is a drug widely prescribed to treat depression. In women fighting breast cancer it is not uncommon to be prescribed Paxil. The newest research should cause health practitioners to give that practice a second thought. A team of California researchers developed a drug screening method which they applied […]

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