By Alan M. Kirschenbaum – Today the Office of Pharmacy Affairs (“OPA”) of the Health Resources Services Administration (“HRSA”) published in the Federal Register its first proposed regulation under the 340B Drug Discount Program since the Program was established in 1992. This Program, authorized under section …
By Ricardo Carvajal – In a report titled “Seafood Safety: FDA Needs to Improve Oversight of Imported Seafood and Better Leverage Limited Resources,” GAO found fault with many aspects of FDA’s imported seafood safety program. GAO set the stage for its review by noting that more …
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 …
In his recent article appearing in FDLI Update, Hyman, Phelps & McNamara, P.C. Associate Peter M. Jaensch examines the increasing legislative efforts by states to require prescriptions for products containing methamphetamine precursors (such as pseudoephedrine and ephedrine), and to list them as Controlled Substances. Mr. …
By Kurt R. Karst – Last Friday, ISTA Pharmaceuticals, Inc. (“ISTA”) filed a Complaint and a Motion for a Temporary Restraining Order and a Preliminary Injunction in the U.S. District Court for the District of Columbia seeking to vacate FDA’s May 11, 2011 approval of Coastal …
By Kurt R. Karst – Last week, the Federal Trade Commission (“FTC”) announced that the Commission’s Bureau of Competition (“Bureau”) sent letters (here, here, and here) to Sanofi-Aventis U.S. LLC, Watson Pharmaceuticals, Inc., and Synthon Holding B.V. notifying them that the Bureau believes the companies violated …
By Robert A. Dormer – In an August 2009 speech to the Food and Drug Law Institute, FDA Commissioner Margaret A. Hamburg, M.D., emphasized the importance of enforcement (see our previous post here). Among other actions announced by Dr. Hamburg was a warning letter “close-out” process. …
By Cassandra A. Soltis – In a May 6, 2011, letter to Dr. Margaret Hamburg, Commissioner of the U.S. Food and Drug Administration (“FDA” or “the Agency”), 10 congressional leaders requested the Agency to “take immediate action” against Brazilian Blowout Solution, Acai Professional Smoothing Solution, and …
Hyman, Phelps & McNamara, P.C., Director Josephine M. Torrente will be moderating a session at the Food and Drug Law Institute’s (“FDLI’s”) upcoming 1-day conference on Risk Evaluation and Mitigation Strategies (“REMS”), which were created under the 2007 FDA Amendments Act. The FDLI conference, for …
By Jeffrey N. Wasserstein – As aficionados of all things social media (see our prior postings here, here, here, and here) (other than kitten videos, enough with those already!) we couldn’t help but notice a recent Untitled Letter to Warner Chilcott, LLC, relating to a YouTube video. A …
By Kurt R. Karst – On May 10th, the U.S. District Court for the District of Columbia ruled in FDA’s favor in a case filed last July by Graceway Pharmaceuticals, LLC (“Graceway”) stemming from the Agency’s January 2010 denial of a Graceway citizen petition and approval …
By Kurt R. Karst – On May 9th, FDA announced the May 10th publication of a Federal Register notice proposing and requesting comment on the structure of a user fee program for applications for biosimilar and interchangeable biological products submitted under section 351(k) of the Public …
By Jamie K. Wolszon – ReGen Biologics, Inc. (“ReGen”) has petitioned the U.S. Court of Appeals for the District of Columbia Circuit (“D.C. Circuit”) to review the Center for Devices and Radiological Health (“CDRH”)’s March 30, 2011 order that rescinded the company’s 510(k) clearance of a …
By Kurt R. Karst – While we were at the American Conference Institute’s conference on Paragraph IV Disputes last week, the Federal Trade Commission (“FTC”) announced the publication of its annual summary of agreements filed with the Commission during Fiscal Year 2010 – “Agreements Filed with …
By Wes Siegner & Susan J. Matthees – On April 6, only 2 weeks behind schedule, FDA issued proposed rules (here and here) implementing section 4205 of the Patient Protection and Affordable Care Act of 2010 (“PPACA”), which requires certain restaurants and vending machines to disclose …
