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 …
By Karla L. Palmer – The Senate passed a bill last Thursday, December 11, 2014, that will prohibit the use of certain designer anabolic steroids. H.R. 4771, titled the Designer Anabolic Steroid Control Act (“DASCA”), adds 25 specific over-the-counter designer substances to the category of "anabolic …
By Karla L. Palmer – Senators John Cornyn (R-TX) and Sherrod Brown (D-OH) introduced legislation late last week that would allow a pharmacist to dispense a controlled substance prescription for a patient and deliver the drug to a practitioner for administration in the doctor’s office. S. …
By Karla L. Palmer – Late last week, Senators Orrin Hatch (R-UT) and Sheldon Whitehouse (D-RI), both members of the Senate Committee on Health, Education, Labor, & Pensions, announced the introduction of S. 2862, the “Regulatory Transparency, Patient Access, and Effective Drug Enforcement Act.” The legislation …
By Larry K. Houck & Andrew J. Hull – Last week, the Drug Enforcement Administration (“DEA”) published its final rule implementing the Secure and Responsible Drug Disposal Act of 2010 (“Disposal Act”). 79 Fed. Reg. 53,520 (Sept. 9, 2014). A post appeared here when DEA issued …
