Study Group: Pharmaceutical and Biotechnology Experts: Lawyers (US)(?)
Council Members in this Study Group: 56
This study group may include professors, attorneys, former regulatory officers, and consultants knowledgeable on topics such as law and litigation issues, lobbying, policy and government, elections, antitrust, immigration, intellectual property, and legislation, among others.
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GLG NewsSMAnalyses by this Study Group's Experts(?)
Opinions and analyses expressed in GLG News are solely those of the author. See the Terms of Use for details.
The Financial Responsibility Rests with The Manufacturer | 03-14-2008
Analysis of:
Heparin and other outsourced pharmaceuticals | online.wsj.com
Author: GLG Expert Contributor
The financial responsibity will lie with Baxter, not the FDA. Perhaps moral or political responsibility (and fall out) will rest with the FDA, but that is of no help to those harmed by the Heparin. Their only recourse is to sue the manufacturer.
The FDA has become a tool of politics rather than public safety | 03-14-2008
Analysis of:
Court Allows Suit Against Drug Maker | www.nytimes.com
Author: GLG Expert Contributor
Under the current administration, the FDA has tried to use drug approval as a shield. In some cases, the current court has held warning approval to bar lawsuits. However, this can be remedied by Congress explicitly clarifying that the FDA approval of a drug does not preempt state law....
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