Health Affairs March 21, 2025
Gregory D. Curfman, Deepika Baskar, Marcia Boumil

In the United States, the safety of prescription drugs is overseen along two parallel pathways. Federal regulation is provided by the Food and Drug Administration (FDA), which works to ensure the efficacy and safety of prescription drugs. On the state level, drug safety is subject to the legal standards of each jurisdiction, where tort laws can be invoked to ensure such matters as adequate warnings to consumers. Both pathways provide powerful incentives for pharmaceutical companies to market only those products that are safe and effective and to openly disclose precautions and adverse effects. Congress intended these two parallel pathways of the regulatory scheme to complement each other.

In re: Fosamax (Alendronate Sodium) Products Liability Litigation is a legal case that...

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