FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Solicitor General OK’d to Argue for Merck in Fosamax Case

Dec. 13, 2018
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The U.S. Supreme Court granted Acting Solicitor General Jeffrey Wall’s request that he be allowed to present oral arguments in support of Merck in an ongoing liability case regarding its osteoporosis drug, Fosamax.

The lawsuit involves Fosamax’s potential bone fracture risks, which were not included as warnings on the drug’s labeling. Merck argued that when it tried to address the warning, the FDA rejected its labeling changes — and the agency should therefore be liable.

The case addresses circumstances where the FDA’s decision to reject proposed labeling changes of a brand drug pre-empts failure-to-warn laws.

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