Scott Gottlieb, the new head of the U.S. Food and Drug Administration is expected to prioritize the rule that restores the ability of consumers to sue generic drug makers under state laws for failure to update warning labels. Gottlieb has also made decisions regarding the nutritional content of menus and labels, giving one deadline to all manufacturers. The FDA must also make significant actions under the Cures Act, in addition to new processes for drug pricing.
Partner Michael Werner said that Gottlieb may also seek to curb drug costs by streamlining clinical trials or partnering in some way with the Centers for Medicare & Medicaid Services. He added that the question is not so much whether Gottlieb tackles drug prices but how.
“I think he's clearly going to deal with that,” Mr. Werner said.
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