Category Archives: FDA

Direct Mailers for Aranesp Targeted by FDA

The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) recently criticized the makers of Aranesp for a direct mailer that was allegedly in violation of the Federal Food, Drug and Cosmetic Act (FD&C Act). Specifically, the mailer was found to be false or misleading because it omitted important risk information, suggested use beyond that which was substantiated, made unsubstantiated efficacy claims, and omitted material facts. OPDP also found that the mailer evidenced that Aranesp was intended for a new…

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This Week’s Life Science Headlines

        Litigation

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This Week’s Life Science Headlines

        Litigation

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United States Supreme Court to Determine Whether It Should Hear Lupron Labeling Suit

The United States Supreme Court has been asked to determine whether a drug manufacturer’s older labeling is admissible to establish its failure to warn consumers of a product’s dangerous side effects.  See the Petition for Writ of Certiorari here.   In Klein v. TAP Pharmaceutical, 518 Fed.Appx. 583 (9th Cir. May 14, 2013), the plaintiff alleged a drug manufactured and marketed by TAP Pharmaceuticals, in a joint venture with Abbott Laboratories, did not contain adequate warnings regarding the dangerous side effects associated with Lupron…

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This Week’s Life Science Headlines

        Litigation

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McIntyre Prevails Again – Contacts with the U.S. Are Insufficient to Establish Jurisdiction in Arkansas

In keeping with McIntyre, the Eastern District of Arkansas has ruled that the foreign manufacturer of the pharmaceutical metronidazole is not subject to jurisdiction.  In the Woods and Brinker matters the plaintiffs alleged that they were injured by contaminated metronidazole and they made claim under the Arkansas Product Liability Act.  The decision is available, click here.  The metronidazole was manufactured in India by Claris Lifesciences Limited (Claris India) pursuant to a supply agreement with Pfizer. Pfizer then sold the drug as its own with a…

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This Week’s Life Science Headlines

        Litigation

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D.C. Circuit to Determine if FDA can Regulate Stem Cell Treatments

The intersection of what is the practice of medicine and what is a regulated drug or biologic is an interesting place with constitutional and regulatory implications. These issues have come to the forefront in a significant case involving an autologous stem cell procedure used by an orthopedic group in Colorado.  In United States of America v. Regenerative Sciences, LLC, 878 F. Supp. 2d. 248 (D.D.C. 2012), available here,  a D.C. district court judge issued an opinion addressing many of these constitutional and regulatory issues, which…

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FDA e-Learning Course on Evaluating Drug Promotion

Off label promotion of drugs and devices is an issue that the FDA looks at very closely. Such off label promotion risks the product being viewed as misbranded which has significant regulatory and litigation risk. Companies and the lawyers that represent them in these kinds of cases are well aware of the importance of vigilance in preventing off label promotion. The FDA is now taking an educational role for consumers and health care providers. Together with Medscape, it is offering a continuing education course, intended…

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Last Week’s Important Headlines

Here are some other notable decisions and developments from last week in the Life Science area: Litigation

Regulatory

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