1. Short title
This Act may be cited as the “FDA Opioid Labeling Accuracy Act”.
FDA Opioid Labeling Accuracy Act
A BILL
To prohibit the labeling of certain opioid drugs recommending use for long-term chronic pain.
2. Labeling prohibition
In general— Notwithstanding any other provision of law, the Secretary of Health and Human Services (referred to in this Act as the “Secretary”) may not approve labeling for an extended release or long-acting opioid analgesic drug unless, as applicable—
the labeling provides that such drug is not intended for the treatment of chronic pain, except in the case of—
treatment of pain related to cancer;
end-of-life care; or
a prescriber determination that, with respect to a particular patient, other non-opioid pain management treatments are inadequate or inappropriate; or
the labeling is consistent with the regulations promulgated by the Secretary pursuant to subsection (b).
Study and labeling regulations—
In general— Not later than 1 year after the date of enactment of this Act, the Secretary shall—
conduct a study on the efficacy of opioid analgesic drugs for long-term chronic pain management; and
based on such study, promulgate regulations regarding the labeling for extended release or long-acting opioid analgesic drugs, as scientifically appropriate.
Updates— The Secretary may update the regulations promulgated under paragraph (1)(B), as appropriate.