Sec. 7. Federal licensure of pharmaceutical representatives who promote certain opioids
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Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb et seq.) is amended by adding at the end the following: The Secretary, in consultation with the Attorney General, shall establish a licensure program for pharmaceutical representatives described in subsection (b). Beginning on July 1, 2021, no individual described in paragraph
(2)may engage in the marketing or promoting of opioid drugs unless such individual is licensed under this section. An individual required to obtain a license under this section is any individual who, on behalf of a drug manufacturer, engaged, on more than 15 days in a calendar year, in the marketing or promotion to health care professionals, including educational or sales communications, meetings or paid events, and the provision of goods, gifts, and samples, of any opioid drug (other than methadone) that is listed in schedule II of section 202(c) of the Controlled Substances Act. Each license issued under this section shall be valid for 3 years, and may be renewed for additional 3-year periods. An individual required to obtain a license under this section shall— submit to the Secretary, at such time and in such manner as the Secretary may require— such information as the Secretary may require; and a registration fee in the amount of $3,000; certify that such individual has completed training on ethics, pharmaceutical marketing regulations, the CDC Guidelines for Prescribing Opioids for Chronic Pain , published by the Centers for Disease Control and Prevention in 2016 (or any successor document) or the FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics , and applicable Federal laws pertaining to drug marketing, labeling, and clinical trials, as the Secretary may require; certify that such individual will not engage in any illegal, fraudulent, misleading, or other deceptive marketing of schedule II opioid drugs; and file with the Secretary annual reports disclosing the names of providers visited and any drug samples or gifts such individual gives any such provider. The manufacturer who employs or contracts with any individual required to obtain a license under this section shall include in reports required under section 1128G of the Social Security Act the name of each such licensed individual that provides payments or other transfers of value required to be reported under such section 1128G that relates to an opioid drug that is listed in schedule II of the Controlled Substances Act. .
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Sec. 7
Federal licensure of pharmaceutical representatives who promote certain opioids
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