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. …
By Larry K. Houck – A bipartisan group of senators representing Oregon, Colorado and Washington, states that have legalized nonmedical use of marijuana, introduced legislation that would protect financial institutions from adverse action by federal banking regulators for providing services to legal marijuana businesses. The “Marijuana …
By Karla L. Palmer – As announced in the Federal Register on June 3, 2015, FDA is proposing to deschedule [123I]Ioflupane (ioflupane) from Schedule II of the Controlled Substances Act (CSA). Ioflupane is an active pharmaceutical ingredient and new molecular entity in DaTscan, which is a …
By John A. Gilbert, Jr. – After more than four months without any substantive registrant decisions, the Drug Enforcement Administration (“DEA”) published 11 administrative decisions within two days last week. Among these are two related cases involving allegations that a pharmacist failed to verify a prescriber DEA …
By Karla L. Palmer - Earlier this week, the GAO released the Testimony of Marcia Crosse, Director, Health Care, before the Senate Caucus on International Narcotics Control. The statement, titled, “Controlled Substances: DEA Needs to Better Manage its Quota Process and Improve Coordination with FDA,” provides a …
By John A. Gilbert – On March 16th, the U.S. House of Representatives passed by voice vote H.R. 639, the Improving Regulatory Transparency for New Medical Therapies Act, which would amend the Federal Food, Drug & Cosmetic Act (FD&C Act) and the Controlled Substances Act (CSA) …
By Karla L. Palmer – On March 4, 2015, the U.S. General Accountability Office (GAO) released a lengthy and detailed report, titled “Better Management of the Quota Process for Controlled Substances Needed; Coordination between DEA and FDA Should Be Improved,” addressing controlled substance shortages potentially resulting …
By Karla L. Palmer – A very busy House Energy and Commerce’s Subcommittee on Health (chaired by Joe Pitts (R-PA)) held a hearing earlier this week to review six bi-partisan bills intended to benefit veterans, address the prescription drug abuse crisis, secure access to medical care, and improve certain …
