FDA Accountability for Public Safety Act This bill amends the Comprehensive Addiction and Recovery Act of 2016 to expand the scope of the Food and Drug Administration (FDA) advisory committee to make recommendations regarding supplemental applications for opioids. Currently, the committee only makes recommendations on new drug applications. Only the Commissioner of Food and Drugs may approve a new drug application or supplement to an application for an opioid against the recommendation of the committee. If the Commissioner approves a drug against the recommendation of the committee, the Commissioner must: (1) submit a report to Congress that includes the evidence regarding patient safety that supports the Commissioner's decision and a disclosure of any potential conflicts of interest of FDA officials involved in the decision; and (2) testify before Congress regarding the decision, upon request. Such a drug cannot be sold until the Commissioner has submitted the report.
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Timeline
Introduced in Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Health
Congressional oversightDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationDrug trafficking and controlled substancesFederal officialsFood and Drug Administration (FDA)Government ethics and transparency, public corruptionMarketing and advertisingPrescription drugs
A bill to establish procedures regarding the approval of opioid drugs by the Food and Drug Administration.
USA115th CongressS-1078| Senate
| Updated: 5/9/2017
FDA Accountability for Public Safety Act This bill amends the Comprehensive Addiction and Recovery Act of 2016 to expand the scope of the Food and Drug Administration (FDA) advisory committee to make recommendations regarding supplemental applications for opioids. Currently, the committee only makes recommendations on new drug applications. Only the Commissioner of Food and Drugs may approve a new drug application or supplement to an application for an opioid against the recommendation of the committee. If the Commissioner approves a drug against the recommendation of the committee, the Commissioner must: (1) submit a report to Congress that includes the evidence regarding patient safety that supports the Commissioner's decision and a disclosure of any potential conflicts of interest of FDA officials involved in the decision; and (2) testify before Congress regarding the decision, upon request. Such a drug cannot be sold until the Commissioner has submitted the report.
Congressional oversightDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationDrug trafficking and controlled substancesFederal officialsFood and Drug Administration (FDA)Government ethics and transparency, public corruptionMarketing and advertisingPrescription drugs