FDA Accountability for Public Safety Act
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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.
These links require the bill number to appear in the filing's source-reported specific issue text. Client expenses and lobbying-firm income are separate disclosure fields.
Filing registrants (1)
2018 · fourth_quarter · Alcohol and Drug Abuse
H.R. 714 Use of Medicinal Marihuana H.R. 715 Rescheduling of Marihuana H.R. 975 Controlled Substances Act Application to Marihuana H.R. 1781 Synthetic Opioids H.R. 1824 Federal and State Marijuana Policy Gap Reduction S. 581 Opioids Addiction Information in Medical Records S. 780 Federal and State Marijuana Policy Gap Reduction H.R. 2020 Rescheduling of Marijuana H.R. 2063 Opioid Dispensary Registration Training Condition S. 1078 FDA Opioid Approval Procedures S. 1079 FDA Opioid Approval and Revocation S. 1327 Controlled Substance Analogues Regulation H.R. 3374 Drunk Driving H.R. 3534 State Legalized Marijuana S. 1553 Schedule 1 Controlled Substances S. 1554 Controlled Substance Continuing Education S. 1689 Controlled Substances Act H.R. 3964 Registration Requirements for Prescribers of Opioids H.R. 4482 Opioid Abuse and Addiction S. 2008 Opioid Epidemic and Drug Sample Backlogs H.R. 4903 Opioid Usage Reduction Best Practices Study H.R. 4922 Fentanyl Analogues H.R. 5109 Opioid Epidemic Distribution of Resources S. 2437 Opioid Grant Program S. 2440 Opioid Epidemic S. 2535 Opioid Quotas H.R. 5473 Alternative Methods for Data Collection H.R. 5581 Prescribers of Controlled Substances H.R. 5590 Medicare and Opioid Addictions H.R. 5723 Medicare Payment Advisory Commission H.R. 5782 Pharmaceutical Company Accountability S. 2680 Opioid Crisis S. 2691 Pharmaceutical Companies and Illegal Marketing S. 2729 Prevention of Prescription Opioid Misuse S. 2838 Reporting Information on Distribution of Opioids S. 2848 Controlled Substances and Alcohol Testing H.R. 6491 Reporting of Information on Distribution of Opioids H.R. 6608 Prescription Drug Monitoring Programs Data Collection H.R. 5812 Controlled Substance Overdose Prevention Activities
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate
Bills with similar content found using semantic analysis.
Sources: Congress.gov
Client expense: $1,030,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), Federal Deposit Insurance Corporation (FDIC), Federal Emergency Management Agency (FEMA), HOUSE OF REPRESENTATIVES, Natl Credit Union Administration (NCUA), Natl Economic Council (NEC), Natl Security Council (NSC), SENATE, Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR)
2018 · third_quarter · Alcohol and Drug Abuse
H.R. 714 Use of Medicinal Marihuana H.R. 715 Rescheduling of Marihuana H.R. 975 Controlled Substances Act Application to Marihuana H.R. 1781 Synthetic Opioids H.R. 1824 Federal and State Marijuana Policy Gap Reduction S. 581 Opioids Addiction Information in Medical Records S. 780 Federal and State Marijuana Policy Gap Reduction H.R. 2020 Rescheduling of Marijuana H.R. 2063 Opioid Dispensary Registration Training Condition S. 1078 FDA Opioid Approval Procedures S. 1079 FDA Opioid Approval and Revocation S. 1327 Controlled Substance Analogues Regulation H.R. 3374 Drunk Driving H.R. 3534 State Legalized Marijuana S. 1553 Schedule 1 Controlled Substances S. 1554 Controlled Substance Continuing Education S. 1689 Controlled Substances Act H.R. 3964 Registration Requirements for Prescribers of Opioids H.R. 4482 Opioid Abuse and Addiction S. 2008 Opioid Epidemic and Drug Sample Backlogs H.R. 4903 Opioid Usage Reduction Best Practices Study H.R. 4922 Fentanyl Analogues H.R. 5109 Opioid Epidemic Distribution of Resources S. 2437 Opioid Grant Program S. 2440 Opioid Epidemic S. 2535 Opioid Quotas H.R. 5473 Alternative Methods for Data Collection H.R. 5581 Prescribers of Controlled Substances H.R. 5590 Medicare and Opioid Addictions H.R. 5723 Medicare Payment Advisory Commission H.R. 5782 Pharmaceutical Company Accountability S. 2680 Opioid Crisis S. 2691 Pharmaceutical Companies and Illegal Marketing S. 2729 Prevention of Prescription Opioid Misuse S. 2838 Reporting Information on Distribution of Opioids S. 2848 Controlled Substances and Alcohol Testing H.R. 6491 Reporting of Information on Distribution of Opioids H.R. 6608 Prescription Drug Monitoring Programs Data Collection H.R. 5812 Controlled Substance Overdose Prevention Activities
Client expense: $1,070,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), Federal Emergency Management Agency (FEMA), HOUSE OF REPRESENTATIVES, Natl Economic Council (NEC), Natl Security Council (NSC), SENATE, Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR)
2018 · second_quarter · Alcohol and Drug Abuse
H.R. 714 Use of Medicinal Marihuana H.R. 715 Rescheduling of Marihuana H.R. 975 Controlled Substances Act Application to Marihuana H.R. 1781 Synthetic Opioids H.R. 1824 Federal and State Marijuana Policy Gap Reduction S. 581 Opioids Addiction Information in Medical Records S. 780 Federal and State Marijuana Policy Gap Reduction H.R. 2020 Rescheduling of Marijuana H.R. 2063 Opioid Dispensary Registration Training Condition S. 1078 FDA Opioid Approval Procedures S. 1079 FDA Opioid Approval and Revocation S. 1327 Controlled Substance Analogues Regulation H.R. 3374 Drunk Driving H.R. 3534 State Legalized Marijuana S. 1553 Schedule 1 Controlled Substances S. 1554 Controlled Substance Continuing Education S. 1689 Controlled Substances Act H.R. 3964 Registration Requirements for Prescribers of Opioids H.R. 4482 Opioid Abuse and Addiction S. 2008 Opioid Epidemic and Drug Sample Backlogs H.R. 4903 Opioid Usage Reduction Best Practices Study H.R. 4922 Fentanyl Analogues H.R. 5109 Opioid Epidemic Distribution of Resources S. 2437 Opioid Grant Program S. 2440 Opioid Epidemic S. 2535 Opioid Quotas **Issues lobbied without specific bill number: Workers' Compensation Medicare Set-Aside H.R. 5473 Alternative Methods for Data Collection H.R. 5581 Prescribers of Controlled Substances H.R. 5590 Medicare and Opioid Addictions H.R. 5723 Medicare Payment Advisory Commission H.R. 5782 Pharmaceutical Company Accountability S. 2680 Opioid Crisis S. 2691 Pharmaceutical Companies and Illegal Marketing S. 2729 Prevention of Prescription Opioid Misuse S. 2838 Reporting Information on Distribution of Opioids S. 2848 Controlled Substances and Alcohol Testing
Client expense: $1,590,000 · Firm income: Not reported
Government targets: Executive Office of the President (EOP), Federal Emergency Management Agency (FEMA), HOUSE OF REPRESENTATIVES, Natl Economic Council (NEC), Natl Security Council (NSC), SENATE, Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR)
2018 · first_quarter · Alcohol and Drug Abuse
H.R. 714 Use of Medicinal Marihuana H.R. 715 Rescheduling of Marihuana H.R. 975 Controlled Substances Act Application to Marihuana H.R. 1781 Synthetic Opioids H.R. 1824 Federal and State Marijuana Policy Gap Reduction S. 581 Opioids Addiction Information in Medical Records S. 780 Federal and State Marijuana Policy Gap Reduction H.R. 2020 Rescheduling of Marijuana H.R. 2063 Opioid Dispensary Registration Training Condition S. 1078 FDA Opioid Approval Procedures S. 1079 FDA Opioid Approval and Revocation S. 1327 Controlled Substance Analogues Regulation H.R. 3374 Drunk Driving H.R. 3534 State Legalized Marijuana S. 1553 Schedule 1 Controlled Substances S. 1554 Controlled Substance Continuing Education S. 1689 Controlled Substances Act H.R. 3964 Registration Requirements for Prescribers of Opioids H.R. 4482 Opioid Abuse and Addiction S. 2008 Opioid Epidemic and Drug Sample Backlogs H.R. 4903 Opioid Usage Reduction Best Practices Study H.R. 4922 Fentanyl Analogues H.R. 5109 Opioid Epidemic Distribution of Resources S. 2437 Opioid Grant Program S. 2440 Opioid Epidemic S. 2535 Opioid Quotas **Issues lobbied without specific bill number: Workers' Compensation Medicare Set-Aside
Client expense: $1,220,000 · Firm income: Not reported
Government targets: Executive Office of the President (EOP), Federal Emergency Management Agency (FEMA), HOUSE OF REPRESENTATIVES, Natl Economic Council (NEC), Natl Security Council (NSC), SENATE, Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR)
2017 · fourth_quarter · Alcohol and Drug Abuse
H.R. 714 Use of Medicinal Marihuana H.R. 715 Rescheduling of Marihuana H.R. 975 Controlled Substances Act Application to Marihuana H.R. 1781 Synthetic Opioids H.R. 1824 Federal and State Marijuana Policy Gap Reduction S. 581 Opioids Addiction Information in Medical Records S. 780 Federal and State Marijuana Policy Gap Reduction H.R. 2020 Rescheduling of Marijuana H.R. 2063 Opioid Dispensary Registration Training Condition S. 1078 FDA Opioid Approval Procedures S. 1079 FDA Opioid Approval and Revocation S. 1327 Controlled Substance Analogues Regulation H.R. 3374 Drunk Driving H.R. 3534 State Legalized Marijuana S. 1553 Schedule 1 Controlled Substances S. 1554 Controlled Substance Continuing Education S. 1689 Controlled Substances Act H.R. 3964 Registration Requirements for Prescribers of Opioids H.R. 4482 Opioid Abuse and Addiction S. 2008 Opioid Epidemic and Drug Sample Backlogs
Client expense: $1,390,000 · Firm income: Not reported
Government targets: Executive Office of the President (EOP), Federal Emergency Management Agency (FEMA), HOUSE OF REPRESENTATIVES, Natl Economic Council (NEC), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of the Vice President of the United States, SENATE, Treasury, Dept of, U.S. Trade Representative (USTR)
2017 · third_quarter · Alcohol and Drug Abuse
H.R. 714 Use of Medicinal Marihuana H.R. 715 Rescheduling of Marihuana H.R. 975 Controlled Substances Act Application to Marihuana H.R. 1781 Synthetic Opioids H.R. 1824 Federal and State Marijuana Policy Gap Reduction S. 581 Opioids Addiction Information in Medical Records S. 780 Federal and State Marijuana Policy Gap Reduction H.R. 2020 Rescheduling of Marijuana H.R. 2063 Opioid Dispensary Registration Training Condition S. 1078 FDA Opioid Approval Procedures S. 1079 FDA Opioid Approval and Revocation S. 1327 Controlled Substance Analogues Regulation H.R. 3374 Drunk Driving H.R. 3534 State Legalized Marijuana S. 1553 Schedule 1 Controlled Substances S. 1554 Controlled Substance Continuing Education S. 1689 Controlled Substances Act
Client expense: $1,250,000 · Firm income: Not reported
2017 · second_quarter · Alcohol and Drug Abuse
H.R. 714 Use of Medicinal Marihuana H.R. 715 Rescheduling of Marihuana H.R. 975 Controlled Substances Act Application to Marihuana H.R. 1781 Synthetic Opioids H.R. 1824 Federal and State Marijuana Policy Gap Reduction S. 581 Opioids Addiction Information in Medical Records S. 780 Federal and State Marijuana Policy Gap Reduction H.R. 2020 Rescheduling of Marijuana H.R. 2063 Opioid Dispensary Registration Training Condition S. 1078 FDA Opioid Approval Procedures S. 1079 FDA Opioid Approval and Revocation S. 1327 Controlled Substance Analogues Regulation
Client expense: $1,460,000 · Firm income: Not reported
Government targets: Executive Office of the President (EOP), Federal Emergency Management Agency (FEMA), HOUSE OF REPRESENTATIVES, Natl Economic Council (NEC), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of the Vice President of the United States, SENATE, Treasury, Dept of, U.S. Trade Representative (USTR)
Government targets: HOUSE OF REPRESENTATIVES, SENATE