By Delia A. Deschaine – Various members of industry recently joined together in filing a citizen petition with FDA. Citizen Petition, Docket No. FDA-2013-P-1711 (hereinafter “Citizen Petition”). The Citizen Petition responds to a statement made by CDER Director, Janet Woodcock, M.D. in October 2013 that FDA intends …
By Delia A. Stubbs – Pursuant to 21 U.S.C. § 811(h), DEA may temporarily place substances in Schedule I of the List of Controlled Substances upon a finding that such action is necessary to avoid an imminent hazard to public health and safety. Using that authority, …
By Delia A. Stubbs & John A. Gilbert – DEA didn’t waste time during its Thanksgiving break. Monday, in just shy of three weeks of the close of its comment period on its proposed rule, DEA issued a final rule placing perampanel in Schedule III. We …
The American Conference Institute will be holding its inaugural forum on controlled substances in Washington, D.C. from Thursday January 16 to Friday, January 17, 2014. A copy of the conference program can be obtained here. Hyman, Phelps & McNamara, P.C.’s John A. Gilbert will be …
By John A. Gilbert & Delia A. Stubbs – In a decision published this week, DEA denied an application for a pharmacy registration on the basis that the owner-pharmacist had previously ignored “red flags” and generally failed to exercise her corresponding responsibility in filling prescriptions. Wheatland …
By Karla L. Palmer – On Monday, November 18, 2013, DEA released the 2013 National Drug Threat Assessment Summary, which provides an assessment of the threat posed to the United States by trafficking and abuse of illicit substances and non-medical use of controlled prescription drugs. The …
By Karla L. Palmer – On Monday, November 4, 2013, the Drug Enforcement Administration (“DEA”) published a notice of proposed rulemaking (“NPR” ), proposing to place the substance 2 –((diemthylamino)methyl)-1-(3-methyloxyphenyl) cyclohexanol), and its salts, isomers, salts of isomers, and all isometric configurations of possible forms, …
By Delia A. Stubbs – Earlier this week, the U.S. Court of Appeals for the D.C. Circuit denied Eisai, Inc.’s (“Eisai’s”) petition to order DEA – in essence – to get moving on the scheduling of its drug, FYCOMPA (perampanel), which FDA approved in October 2012 …
By Delia A. Stubbs – While typically not made public, today, FDA issued a statement that it intends to forward a recommendation to DEA by December to move hydrocodone combination products from their current placement in Schedule III to Schedule II. That change would mean, among …
By Delia A. Stubbs – As previously reported, the Physicians for Responsible Opioid Prescribing (“PROP”) filed a Citizen Petition in March requesting that FDA limit the labeling of “controlled release” opioids to severe-only pain in non-cancer patients. The petition also requested that FDA impose certain …
By John A. Gilbert – Earlier this week, Eisai, Inc. (“Eisai”) filed a Petition for A Writ of Mandamus in the U.S. Court of Appeals for the District of Columbia Circuit to force the Drug Enforcement Administration (“DEA”) to issue a Notice of Proposed Rulemaking (“NPRM”) …
By Joseph W. Cormier – Last week, the Administrative Conference of the United States ("ACUS") made four recommendations to the Executive Branch and independent agencies, three of which may be of interest to readers of this blog. Among its first recommendations this year, the ACUS …
By Larry K. Houck – Pharmacists are under increasing pressure to take extraordinary steps to verify prescriptions for controlled substances, especially in light of the fact that the Drug Enforcement Administration (“DEA”) has asserted that pharmacists are the gatekeepers or the “last line of defense” …
A recent Freedom of Information Act (“FOIA”) decision from the U.S. Court of Appeals for the Fourth Circuit sends a strong message to federal agencies that the statutory time limits for FOIA responses must be honored. On February 29, 2008, John J. Coleman filed a FOIA …
By Delia A. Stubbs – As previously reported, Congress recently introduced the Stop Oxy Abuse Act that would restrict the labeled indications for use of any controlled release drug containing Oxycodone-Hydrochloride (HCl) to “severe-only” versus current labeling of “moderate-to-severe” pain. The legislation is similar to a recent …
