Tag Archives: Controlled Substances Act

SCOTUS to examine “good faith” defense in criminal opioid prescription cases

On Nov. 5, 2021, the U.S. Supreme Court consolidated and granted certiorari to a pair of cases involving physicians who were criminally prosecuted for prescribing controlled substances (specifically, opioids) in violation of the Section 841(a)(1) of the Controlled Substances Act (“CSA”).  The consolidated cases—Ruan v. United States and Kahn v. United States—present questions regarding the … Continue Reading

Public Health Bills Advance

On September 30, 2016, President Obama signed into law S 1878, the Advancing Hope Act, which modifies the FDA’s priority review voucher program for rare pediatric diseases and extends the program through December 31, 2016. In addition, the House has approved a number of health policy bills, including the following: HR 954, the “CO-OP Consumer … Continue Reading

SAMHSA Final Rule on Medication Assisted Treatment for Opioid Use Disorders Reporting Requirements

On September 27, 2016, the Substance Abuse and Mental Health Services Administration (SAMHSA) published a final rule establishing annual reporting requirements for certain practitioners who prescribe buprenorphine-based medication-assisted treatment for opioid disorders under the Controlled Substances Act. As previously reported, SAMHSA published a rule on July 8, 2016 that expanded from 100 to 275 the … Continue Reading

Energy and Commerce Committee Clears Public Health Bills

On September 21, 2016, the House Energy and Commerce Committee unanimously approved the following public health bills: H.R. 4365, Protecting Patient Access to Emergency Medications Act – to amend the Controlled Substances Act (CSA) to enable paramedics and other emergency medical services (EMS) professionals to continue to administer controlled substances to patients under standing orders … Continue Reading

President Obama Signs Zika Priority Review, Controlled Substances Laws

President Obama has signed into law S. 2512, which adds  Zika virus to the Food and Drug Administration priority review voucher program to encourage the development of treatments for neglected tropical diseases. In addition, the President has signed S. 483, the “Ensuring Patient Access and Effective Drug Enforcement Act of 2016.  This law amends the Controlled Substances … Continue Reading

Controlled Substances Act Regulation Legislation Approved by Senate

The Senate recently approved an amended version of S. 483, the Ensuring Patient Access and Effective Drug Enforcement Act of 2015.  The bill, which was approved on March 17, 2016, would clarify the standards an applicant to manufacture or distribute controlled substances must meet in order to obtain a Controlled Substances Act registration, and the … Continue Reading

Controlled Substances Treatment/Regulation Bills Clear Senate Judiciary Committee

The Senate Judiciary Committee approved two bipartisan bills on February 11, 2016 that are intended to address abuse of opioid and other controlled substances and clarify the regulation of controlled substances. First, S. 524, the Comprehensive Addiction and Recovery Act of 2015, includes a wide range of prevention, education, law enforcement, treatment, and recovery provisions, … Continue Reading

Congress Clears Controlled Substances Act Scheduling Legislation

On November 16, 2015, the House of Representatives approved HR 639, the Improving Regulatory Transparency for New Medical Therapies Act, clearing it for the President.  The legislation would amend the Controlled Substances Act (CSA) to make procedural changes intended to improve the efficiency, transparency, and consistency of the Drug Enforcement Agency’s (DEA) process for scheduling … Continue Reading

Energy and Commerce Health Subcommittee Advances Mental Health, Medicaid, Synthetic Drug Legislation

On November 4, 2015, the House Energy and Commerce Health Subcommittee approved the following health policy bills: HR 2646, the Helping Families in Mental Health Crisis Act – includes a series of reforms intended to improve federal mental health research, screening, and treatment programs, some of which have met with strong opposition from House Democrats. … Continue Reading

Senate HELP Committee Approves Mental Health, Opioid Abuse, Drug Scheduling Legislation

On September 30, 2015, the Senate Health, Education, Labor, and Pensions (HELP) Committee approved the following bipartisan legislation:  S. 799, the Protecting Our Infants Act (to combat the rise of prenatal opioid abuse and neonatal abstinence syndrome): S. 1893, the Mental Health Awareness and Improvement Act (to reauthorize and improve programs related to mental health … Continue Reading

House Approves “Ensuring Patient Access and Effective Drug Enforcement Act”

On April 21, 2015, the House of Representatives approved H.R. 471, the Ensuring Patient Access and Effective Drug Enforcement Act of 2015. The bipartisan legislation would clarify the Controlled Substances Act to establish consistent enforcement standards intended to protect against diversion while promoting patient access to medically-necessary controlled substances.… Continue Reading

House Approves Medicare DMEPOS Competitive Bidding, Hospital Observation, Controlled Substances, & Trauma Care Bills

Yesterday the House of Representatives approved the following health policy bills: H.R. 284, the Medicare DMEPOS Competitive Bidding Improvement Act of 2015 – which would require Medicare suppliers that bid under a DME, prosthetics, orthotics, and supplies (DMEPOS) competitive bidding program to obtain a $50,000-$100,000 bid surety bond for each competitive bidding area (CBA).  If … Continue Reading

House to Vote Today on DMEPOS Competitive Bidding, Hospital Observation Policy, and Other Health Policy Bills

On March 16, 2015, the House of Representatives is scheduled to consider the following health policy legislation: H.R. 284, the Medicare DMEPOS Competitive Bidding Improvement Act of 2015 — which would require Medicare suppliers that bid under a DME, prosthetics, orthotics, and supplies (DMEPOS) competitive bidding program to submit binding bids or risk forfeiture of a … Continue Reading

Two Health Policy Laws Enacted, Additional Bills Advance

On August 8, 2014, President Obama signed into law the following two bills approved by the Senate in July: H.R. 4631, the Autism CARES Act, to continue federal research, early identification and intervention, and education related to autism; and H.R. 3548, the Improving Trauma Care Act, to include in the Public Health Service Act definition … Continue Reading

House Energy and Commerce Subcommittee Approves Health Bills

On May 28, 2014 the House Energy and Commerce Subcommittee on Health approved by voice vote three bipartisan public health bills: H.R. 4299, “Improving Regulatory Transparency for New Medical Therapies Act,” which is intended to improve the Drug Enforcement Agency scheduling process for new FDA-approved drugs under the Controlled Substances Act and the registration process for … Continue Reading
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