Trickett Wendler Right to Try Act of 2016

Trickett Wendler Right to Try Act of 2016

This bill bars the federal government from prohibiting or restricting the production, manufacture, distribution, prescribing, or dispensing of an experimental drug, biological product, or device that is: (1) intended to treat a patient who has been diagnosed with a terminal illness; and (2) authorized by, and in accordance with, state law. The federal government may not restrict the possession or use of such a treatment by a patient certified by a physician as having exhausted all other treatment options.

A producer, manufacturer, distributor, prescriber, dispenser, possessor, or user of such a treatment has no liability regarding the treatment.

The outcome of production, manufacture, distribution, prescribing, dispensing, possession, or use of such a treatment may not be used by a federal agency to adversely impact review or approval of the treatment.

The treatment must: (1) have successfully completed a phase 1 (initial, small scale) clinical trial; (2) remain under investigation in a clinical trial approved by the Food and Drug Administration (FDA); and (3) not be approved, licensed, or cleared for sale under the Federal Food, Drug, or Cosmetic Act or the Public Health Service Act.

Not later than 30 days after enactment of this bill, and every 30 days thereafter until implementation is complete, the FDA must report on its progress in implementing a streamlined application process for compassionate use of experimental drugs and biological products.