Tag Archives: Side Effects

Mutual v. Bartlett: A Line in the Sand on Side Effects

The Supreme Court ruled last Monday in the case of Mutual Pharmaceuticals v. Bartlett that generic drug makers cannot change labeling or the formula of a drug after it has been approved by the FDA. The majority, which included Justices Alito, Roberts, Scalia, Kennedy, and Thomas, concluded that federal regulation trumps state tort liability law, […]
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Pfizer Responds to Adverse Events Report

A report released last week by the The Institute for Safe Medication Practices (and covered yesterday on PharmExec.com), listed Pfizer’s smoking cessation drug Chantix as the number one most reported drug for adverse reactions in the first quarter of 2008. The report states that FDA received 1,001 reports of serious side effects for varenicline (the […]
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"Side Effects" and "The Normalization of Suspicion"

In today’s Wall Street Journal, Mark Herrmann, an attorney with Jones Day, co-proprietor of the Drug and Device Law blog, as well as an occasional contributor to Pharm Exec, has a lively review of Alison Bass’ Side Effects, a new book that tells the story of the campaign against Paxil. His bottom line is a […]
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