FDA Drug Approvals, Rulemaking Tested After Chevron Decision (1)

The FDA’s power to determine a drug’s exclusivity or review tobacco marketing applications faces fresh vulnerability to legal battles after the Supreme Court’s decision to nix a legal doctrine that empowered agency interpretations.

The US Supreme Court’s June 28 opinion in Loper Bright Enters. v. Raimondo is expected to open the floodgates for litigation against the Food and Drug Administration after ending the decades-old Chevron doctrine. Under the 1984 decision in Chevron v. Natural Resources Defense Council, courts had accepted a federal agency’s reasonable interpretation of its rulemaking authority when its statute was determined ambiguous.

The FDA is often accused ...