FDA Opioid Labeling Accuracy Act

Bill: 116-s-2089
Sponsor: full_name: Sen. Manchin, Joe, III [D-WV]
Introduced: 2019-07-11
Policy area: Health
Subjects: Administrative law and regulatory procedures

Department of Health and Human Services

Drug safety, medical device, and laboratory regulation

Drug trafficking and controlled substances

Government studies and investigations
Latest action: action_date: 2019-07-11
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Summaries:
action_date: 2019-07-11
action_desc: Introduced in Senate
text: <p><b>FDA Opioid Labeling Accuracy Act</b></p> <p>This bill restricts the labeling of certain opioid drugs recommending use for long-term chronic pain.</p>

tv_txt: II 116th CONGRESS 1st Session S. 2089 IN THE SENATE OF THE UNITED STATES July 11, 2019 Mr. Manchin (for himself and Mr. Braun ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To prohibit the labeling of certain opioid drugs recommending use for long-term chronic pain.

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