By Kurt R. Karst – We thought Eisai Inc.’s (“Eisai”) beef with FDA over New Chemical Entity (“NCE”) exclusivity might resurface at some point . . . and now it has. Last Friday, Eisai filed a Complaint in the U.S. District Court for the District of …
By Kurt R. Karst – We watched the World Cup final between Germany and Argentina this past weekend and were pleased with the outcome (well, at least this blogger was). Things got pretty intense as the minutes in extra time ticked away, edging the match ever …
By John A. Gilbert, Jr. & Larry K. Houck – As expected, the Drug Enforcement Administration (“DEA”) published its final rule in the Federal Register today (79 Fed. Reg. 37,623 (July 2, 2014) placing tramadol (2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol) into schedule IV of the federal Controlled Substances Act (“CSA”). …
By James C. Shehan & Karla L. Palmer – In a curious posting on Friday, June 20, 2014, FDA with little fanfare set forth its latest position on medical marijuana. Amounting to little more than a statement of general support of scientific research on medical marijuana …
By Larry K. Houck – Deputy Assistant Administrator Joseph Rannazzisi, Office of Diversion Control, Drug Enforcement Administration (“DEA”), told the House of Representatives Energy and Commerce’s Subcommittee on Oversight and Investigations on April 29, 2014 that his agency “has steadily increased the frequency of compliance inspections” …
By Kurt R. Karst – On May 29th, the U.S. House of Representatives Committee on Appropriations voted 31-18 during a mark-up session to send to the House floor its version of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015, along …
By Larry K. Houck – Prescriptions issued for controlled substances must contain the patient’s name and address; the drug name, strength and dosage form; the quantity prescribed; directions for use; and the practitioner’s name, address and Drug Enforcement Administration (“DEA”) registration number. DEA advised in its …
By Karla L. Palmer – The Energy and Commerce Committee’s Subcommittee on Health (chaired by Representative Joe Pitts (R-PA)), has scheduled a hearing for Monday, April 7, 2014, at 3:00 p.m. in room 2123 of the Rayburn House Office Building. The hearing is titled “Improving Predictability and …
By John A. Gilbert, Jr. – A new bill introduced in Congress, H.R. 4299 (titled “Improving Regulatory Transparency for New Medical Therapies Act”), would significantly streamline the drug scheduling process for new medical therapies and reduce the potential for unnecessary delays in the availability of these needed …
By John A. Gilbert – The 57th session of the Commission on Narcotic Drugs (“CND”) recently convened in Vienna, Austria. A prominent issue on the first day of the general session included concern over the increased use of cannabis, especially for recreational purposes. The International Narcotics …
By John A. Gilbert, Jr. & Larry K. Houck – A bill introduced in the Maryland House of Delegates, HB 0596, would require wholesale distributors to notify their pharmacy customers at least thirty days prior to “imposing a limit on the quantity” of prescription drugs or …
By Delia A. Deschaine & Larry K. Houck – In just shy of three months following receipt of the Department of Health and Human Services (“HHS”)’s rescheduling recommendation, see prior post here, DEA announced the issuance of a Notice of Proposed Rulemaking (“NPRM”) Thursday to reschedule all …
By Karla L. Palmer – Last week, the United States District Court for the District of Oregon ruled that the Drug Enforcement Administration’s (“DEA”) administrative subpoena powers are not unfettered when it comes to obtaining protected health information (“PHI”) submitted by pharmacies to Oregon’s Prescription Drug …
By John A. Gilbert & Delia A. Deschaine – As previously reported here, late last year, CDER Director, Janet Woodcock issued a statement indicating FDA’s intent to recommend that DEA reclassify hydrocodone-combination products in Schedule II. (We note that scheduling recommendations are made to DEA by …
By Larry K. Houck – The National Association of Boards of Pharmacy (“NABP”), along with a coalition of healthcare stakeholders, recently announced collaborative steps to address prescription drug abuse and practitioner compliance with federal and state corresponding responsibility requirements while ensuring that patients receive needed medical …
