This Special Communication reviews the rules governing confidentiality orders and discusses the tension between these rules and prevailing legal practices relating to court secrecy in medical product litigation, including competing interests among manufacturers, plaintiffs, and courts.
This Viewpoint discusses legislative efforts at the state level to monitor or regulate drug prices and reviews legal challenges raised by industry in response to these efforts.
This Viewpoint uses the legal dispute between Amgen and the US Food and Drug Administration (FDA) regarding the FDA’s denial of market exclusivity for cinacalcet to discuss the FDA policy granting 6 months of market exclusivity as an incentive for manufacturers to conduct efficacy and safety studies in child populations.
This Viewpoint discussed drug companies’ disputed First Amendment rights and the US Food and Drug Administration’s enforcement authority.
This Viewpoint discusses the implications of recent circuit court decisions regarding commercial speech and off-label marketing of prescription drugs.
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