Articles Tagged with FDA

Food SafetyWith a 215 to 144 vote, the U.S. House of Representatives passed the Food Safety Modernization Act, with only minor changes to the Senate’s version of the bill.  With President Obama expected to sign off, the Act will soon become law.  The chief purpose of the Act is to vest the Food and Drug Administration (FDA) with increased authority to monitor food safety.  Until the law is enacted, the FDA does not have direct authority to order food recalls; typically, the agency negotiates terms of voluntary recalls.  In the wake of massive health scares over lettuce, peanut, and spinach in the last few years, the FDA will have increased authority to intervene.

The Act protects whistleblowers employed by companies “engaged in the manufacture, processing, packing, transportation, distribution, reception, holding or importation of food.” Continue reading ›

Allergan recently brought an injunctive action against the FDA asserting the unconstitutionality of several of its provisions regulating off-label promotion. Advancing their First Amendment argument, Allergan employs many of the same arguments put forth in Caronia (for more information on this topic, see here).  However, a primary difference distinguishing Allergan from Caronia lies within Allergan’s Risk Evaluation and Mitigation Strategy. As Allergan argues, providing warnings in compliance with the FDA’s requests constitutes government-compelled speech (warranting strict scrutiny). Continue reading ›

First Amendment challenges to the FDA’s off-label promotion ban are hardly novel, however case law in this area remains relatively unsettled. Drug makers initially rejoiced with the ruling in Washington Legal Foundation, however the case was later vacated.  Case law now appears to be more settled in the wake of Caronia.

First amendment contests are usually brought as either defenses to off-label prosecutions (as in Caronia) or by advocacy groups and drug companies seeking injunctive relief (Washington Legal Foundation). Continue reading ›

In the wake of a large settlement (for more, see here), GlaxoSmithKline attorney Lauren Stevens was indicted for obstruction and making false statements to the FDA. Allegedly, the attorney withheld incriminating documents and made misrepresentations in letters sent to the FDA. In addition to actions related to poor manufacturing, charges also relate to GSK programs to promote off-label uses of Wellbutrin. At the time, the antidepressant was promoted off-label for weight loss. Continue reading ›

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