HR5969-119

What This Bill Does

The LABEL Act creates a federal labeling requirement for abortion-inducing drugs. It amends prescription-drug provisions of the Federal Food, Drug, and Cosmetic Act to deem an abortion-inducing drug misbranded unless the label identifies the name and address of the dispenser and the name of the prescriber. The bill also preempts State or local labeling requirements for abortion-inducing drugs that are not at least as stringent as the new federal requirement. It defines abortion-inducing drug as a drug intended, alone or with another drug, for use or in fact used to kill the unborn child of a woman known to be pregnant or terminate the pregnancy of such a woman. It excludes drugs intended to remove a dead unborn child or treat an ectopic pregnancy. A severability clause says that if any part of the section or amendment is held unconstitutional, the remainder and other applications are not affected.

Who Benefits and How

Patients and consumers seeking identifying information benefit because covered drug labels would name the dispenser and prescriber. Anti-abortion advocates benefit because the bill creates a federal disclosure rule for abortion-inducing drugs and prevents weaker State or local rules. States with stricter labeling approaches benefit because the bill allows requirements at least as stringent as the federal standard. FDA enforcement staff benefit from a misbranding hook tied to dispenser and prescriber identification.

Who Bears the Burden and How

Dispensers of abortion-inducing drugs must put their name and address on the label. Prescribers of abortion-inducing drugs must have their name identified on the label. Drug manufacturers, pharmacies, telehealth providers, and other distribution channels must adjust labeling workflows to avoid misbranding. States and local governments with weaker labeling rules are preempted and cannot enforce less stringent requirements. FDA compliance staff must apply the new misbranding standard and handle disputes over the definition and severability.

Key Provisions

• Amends the Federal Food, Drug, and Cosmetic Act to deem abortion-inducing drugs misbranded unless labels identify the dispenser and prescriber.
• Requires the dispenser's name and address and the prescriber's name on covered drug labels.
• Preempts State and local labeling rules that are not at least as stringent as the federal rule.
• Defines abortion-inducing drug while excluding drugs for ectopic pregnancy treatment or removal of a dead unborn child.
• Provides severability if a provision or application is held unconstitutional.