By John A. Gilbert, Karla L. Palmer & Larry K. Houck – The Food and Drug Administration Safety and Innovation Act (“FDASIA”) (S. 3187), which is on its way to the President for enactment after the Senate passed the bill by a 92-4 vote, may impact …
By Kurt R. Karst – After a round of congratulatory speeches, the U.S. House of Representatives passed H.R. 5651, the FDA Reform Act of 2012, as amended, on May 30th by a vote of 387-5. Unlike the U.S. Senate, which passed its version of the bill …
By Kurt R. Karst – After days of debate and a slew of proposed amendments, the U.S. Senate passed S. 3187, the FDA Safety and Innovation Act, on Thursday afternoon by a roll call vote of 96-1. Senator Bernie Sanders (I-VT), who cast the lone vote against passage, …
By Larry K. Houck – The Drug Enforcement Administration (“DEA”) has published a Final Rule increasing initial registration and renewal fees for all registrants. 77 Fed. Reg. 15,234 (Mar. 15, 2011). DEA published the applicable Notice of Proposed Rulemaking (“NPRM”) on July 6, 2011, which was …
By John A. Gilbert & Larry K. Houck – On February 29, 2012, the Drug Enforcement Administration (“DEA”), exercising its emergency scheduling authority under 21 U.S.C. § 811(h)(2), extended the temporary scheduling of five synthetic cannabinoids: JWH-018, JWH-073, JWH-200, CP-47,497 and cannabicyclohexanol until August 29, 2012. …
By John A. Gilbert, Jr. & Larry K. Houck – The Government Accountability Office (“GAO”) has issued a report focusing on federal agency efforts to educate prescribers and the public about prescription pain reliever abuse and misuse. The report’s title, “Prescription Pain Reliever Abuse: Agencies have …
By James R. Phelps – Over the New Year's Day weekend, The New York Times reported on the shortage of ADHD drugs, with this quote: “‘We have reached out to the D.E.A. and told them that there are shortage issues,’ said Valerie Jensen, associate director of …
By Larry K. Houck – The Drug Enforcement Administration (“DEA”) published its long awaited final rule in the Federal Register today (76 Fed. Reg. 77,330 (Dec. 12, 2011)) placing carisoprodol into schedule IV of the federal Controlled Substances Act (“CSA”). Federal scheduling of carisoprodol follows control …
In his recent article appearing in FDLI Update, Hyman, Phelps & McNamara, P.C. Of Counsel, and former diversion investigator for the Drug Enforcement Administration (“DEA”), Larry K. Houck, explains the scope of DEA pre-registration and cyclic inspections as a step-by-step guide to actions and procedures …
By John A. Gilbert, Jr. & Karla L. Palmer – On Wednesday, October 5, 2011, the DEA published a final rule clarifying when a DEA registrant’s voluntarily surrender of its registration is effective. The final rule amends 21 C.F.R. §§ 1301.52(a) and 1301.62(a) to make it …
By John A. Gilbert, Jr., Karla L. Palmer & Larry K. Houck – The Government Accountability Office (“GAO”) recently issued a report analyzing the Drug Enforcement Administration’s (“DEA’s”) efforts to combat the diversion of legal controlled substances and listed chemicals. As the title suggests, “DEA has …
By Karla L. Palmer & John A. Gilbert – Last week Senator Herb Kohl (D-WI) introduced a bill (S. 1560) to facilitate controlled substance access for residents of residential long-term care facilities. The proposed bill, which would amend the federal Controlled Substances Act (“CSA”), specifically 21 …
By Karla L. Palmer & John A. Gilbert – On September 8, 2011, the Drug Enforcement Administration (“DEA”) published a Notice of Intent to temporarily place into Schedule I of the Federal Controlled Substances Act (“CSA”) three synthetic cathinones. 75 Fed. Reg. 55616 (Sept. 8, 2011). …
By Larry K. Houck – The Drug Enforcement Administration (“DEA”) published a Notice of Proposed Rulemaking (“NPRM”) on July 6, 2011 seeking to raise initial registration and renewal fees for all registrants. 76 Fed. Reg. 39,318 (July 6, 2011). Citing increased diversion control activities, DEA justified …
By John A. Gilbert & Karla L. Palmer – On May 9, 2011, the Drug Enforcement Administration ("DEA") published a proposed rulemaking addressing the “Consolidation of Seizure and Forfeiture Regulations” to conform with the Civil Asset Forfeiture Reform Act ("CAFRA") of 2000. When finalized, the rule will …
