By John A. Gilbert Jr. & Alan M. Kirschenbaum – On Friday, July 22, 2016, President Obama signed into law the Comprehensive Addiction and Recovery Act (“CARA” or “Act”) of 2016, which is intended to help reverse the serious prescription drug abuse trend in the United …
By Larry K. Houck – The Substance Abuse and Mental Health Services Administration (“SAMHSA”) has published a proposed rule that would increase the number of patients with opioid abuse disorder that a qualified physician can treat with buprenorphine. Medication Assisted Treatment for Opioid Use Disorders, 81 …
By Larry K. Houck – The Centers for Disease Control and Prevention (“CDC”) has released its final guidelines for prescribing opioids for chronic pain. CDC Guideline for Prescribing Opioids for Chronic Pain-United States, 2016, Centers for Disease Control and Prevention, Morbidity and Mortality Weekly Report, Mar. …
By John A. Gilbert, Jr. & Larry K. Houck – The Government Accountability Office (“GAO”) recently released a report examining issues related to state marijuana legislation and federal monitoring of such actions. GAO, State Marijuana Legalization: DOJ Should Document Its Approach to Monitoring the Effects of …
By Larry K. Houck – Several recent developments relating to cannabidiol and marijuana occurred over the past several weeks. We summarize them below: One Step Forward for Cannabidiol Research The Drug Enforcement Administration (“DEA”) announced that it has eased some of the regulatory requirements for FDA-approved clinical trials …
By Larry K. Houck – The Centers for Disease Control and Prevention (“CDC”) have published draft guidelines for prescribing opioids for chronic pain and opened a docket seeking public comment. Proposed 2016 Guideline for Prescribing Opioids for Chronic Pain, 80 Fed. Reg. 77,351 (Dec. 14, 2015). …
By Kurt R. Karst – Last Wednesday, November 25, 2015, after a long slog through the legislative process (see our previous post here), President Obama signed into law the Improving Regulatory Transparency for New Medical Therapies Act (H.R.639). (Unlike other bills, H.R.639 doesn’t have a sexy …
The latest issue of the Food and Drug Law Institute’s “Update” magazine features an article written by Hyman, Phelps & McNamara, P.C. attorneys John A. Gilbert, Jr. and Andrew J. Hull. The article, titled “A Matter of Substantial Discretion: A Recent Rift Between DEA and …
By John A. Gilbert, Jr. & Larry K. Houck – Yes, with passage of the State Marihuana (sic) and Regulatory Tolerance (“SMART”) Enforcement Act. The bill, H.R. 3746, introduced by Representative Suzan DelBene (D-WA), would authorize the Attorney General to waive the marijuana provisions of the …
By Larry K. Houck – Ruth Carter, Chief of the Drug Enforcement Administration’s (“DEA”) Office of Liaison and Policy Section, was among the presenters who addressed the 31st Annual Conference of the National Association of State Controlled Substance Authorities (“NASCSA”) this week in Scottsdale, Arizona. Ms. …
By Larry K. Houck – The Centers for Disease Control and Prevention (“CDC”), the nation’s premier agency focusing on public health and safety through disease prevention and control, and a component within the U.S. Department of Health and Human Services, is developing guidelines “to provide recommendations …
By Kurt R. Karst – On September 30, 2015, Judge Randolph D. Moss of the U.S. District Court for the District of Columbia issued his highly-anticipated decision in a lawsuit lodged by Eisai Inc. (“Eisai”) last August challenging FDA's April 2014 denial of a Citizen Petition (Docket No. FDA-2013-P-0884) requesting that the Agency conclude that the …
By Karla L. Palmer – Last week, several congressional representatives announced the introduction of H.R. 3537, the “Synthetic Drug Control Act of 2015.” If enacted, the Synthetic Drug Control Act would strengthen existing federal law (specifically, the Controlled Substances Analogue Enforcement Act) (“Analogue Act”), which provides that …
By Karla L. Palmer – The GAO was asked to review DEA registrants’ and others’ interactions with DEA. The GAO Report, released at the end of July examines the following: (1) To what extent registrants interact with DEA about their Controlled Substances Act (CSA) responsibilities and registrants’ …
By Larry K. Houck – Representatives Bill Johnson (R-Ohio) and Doris Matsui (D-California), members of the House Energy and Commerce Committee, introduced legislation in Congress on July 28th that seeks to curb teenage dextromethorphan (“DXM”) abuse by restricting its sale to individuals under 18 years old. …
