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Full-Text Articles in Law
Off-Label Drug Marketing, The First Amendment, And Federalism, David Orentlicher
Off-Label Drug Marketing, The First Amendment, And Federalism, David Orentlicher
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In this article, Professor Orentlicher explores free speech and federalism issues arising from FDA regulation of off-label uses and off-label marketing of drugs. In light of the FDA's desire to respect state government authority, together with other considerations discussed in this article, he argues for the rejection of the analysis of the Caronia court and to give the FDA significant leeway in its regulation of off-label marketing.
The Prudential Third Party Standing Of Family-Owned Corporations, Matthew I. Hall, Benjamin Means
The Prudential Third Party Standing Of Family-Owned Corporations, Matthew I. Hall, Benjamin Means
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On November 26, 2013, the Supreme Court agreed to decide whether for-profit corporations or their shareholders have standing to challenge federal regulations that implement the Patient Protection and Affordable Care Act (ACA). At issue in the two cases consolidated for appeal, Hobby Lobby and Conestoga Wood Specialties, are regulations mandating that employers with fifty or more employees offer health insurance that includes coverage for all contraceptives approved by the Food and Drug Administration (FDA). The plaintiffs assert that providing certain types of contraceptive care would be contrary to their religious beliefs and allege, therefore, that the mandate violates the Religious …