11/15/2019

Commentary: The Supreme Court and the One-Way Regulatory Ratchet

Earlier this month, the Supreme Court heard oral arguments in Merck v. Albrecht. At issue in the case is when the federal regime for regulating pharmaceutical products (principally through the Food and Drug Administration, or FDA) might preempt state regulatory regimes (principally through tort litigation). However the case is resolved, this area of law is certain to remain a mess—and Congress would be well-advised to clean it up through legislative action.

The Albrecht case concerns Merck’s drug Fosamax, which helps prevent osteoporosis in post-menopausal women. Osteoporosis makes bones brittle—and the drug typically lowers the risk of breaks and other bone injuries in the elderly. But years after Fosamax was approved, some evidence began to emerge that patients taking the drug may have an increased risk of “atypical femoral fracture,” essentially a breaking of the thigh bone from minimal trauma. In other words, a small subset of patients may be more vulnerable to this particular type of bone break, even though the drug successfully insulates most patients from bone breaks caused by osteoporosis.

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