Eight former FDA officials, including former FDA commissioner Andrew von Eschenbach and multiple deputy commissioners, submitted an amicus brief to the Supreme Court yesterday — asking for the Court to review the Mississippi Supreme Court decision that ruled against J&J earlier this year.
Mississippi’s complaint in 2014 accused the mega-company of violating consumer protection laws by not disclosing ovarian cancer risks to women posed by its baby powder containing talc.
J&J sought summary judgment in its appeal to the court, arguing the Mississippi Consumer Protection Act doesn’t apply to the labeling of products regulated by the federal Food and Drug Administration. The Mississippi Supreme Court disagreed, and affirmed a lower court’s previous ruling.
The former officials argue that notice-and-comment rulemaking, which the FDA officials say is rarely used, subverts and upends the FDA’s system and authority over labeling.
“By stripping the FDA’s labeling decisions of preemptive effect unless they first undergo notice-and-comment rulemaking, the decision leaves the agency with an impossible choice: sacrifice the flexibility it needs to oversee thousands of products in an ever-shifting market, or allow its scientifically sound warnings to be crowded out by conflicting state-imposed labels,” the officials wrote.
The ex-officials further reiterated that the FDA lacks time and resources to run every decision through notice-and-comment rulemaking.
“According to the Mississippi Supreme Court, that reality means FDA must share labeling authority with all 50 states, any one of which can require a label specifically rejected by FDA as scientifically unsound,” the officials wrote.
Ultimately they want the Supreme Court to “clarify the law of preemption and prevent the Mississippi Supreme Court’s decision from disrupting FDA’s vital functions,” the writers said.
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