By Kurt R. Karst – In a series of letters, the U.S. Patent and Trademark Office (“PTO”) has clarified when patents covering certain drug products are eligible for a Patent Term Extension (“PTE”). The PTO issued the letters as a result of recent decisions from the …
In the September/October 2010 edition of the Food and Drug Law Institute’s Update publication, HP&M attorney Jennifer B. Davis authored an article, titled “New Use of Old Tools: Career-Ending OIG Exclusion and FDA Debarment.” The article focuses on the Department of Health and Human Service’s …
By Ricardo Carvajal – A California district court dismissed a class action lawsuit alleging that baked-goods products manufactured by Hostess Brands, Inc. are marketed in violation of California law because they are promoted as containing “0 grams of Trans Fat” despite containing partially hydrogenated oils. The …
By John A. Gilbert & Karla L. Palmer – On November 1, 2010, the Deputy Administrator of the Drug Enforcement Administration published for the second time in three years a proposed rule to modify the listing of approved drug products containing dronabinol as Schedule III controlled …
By Kurt R. Karst – Just as FDA was getting started with its two-day public meeting earlier this week on the Approval Pathway for Biosimilar and Interchangeable Biological Products, which occurred a little more than seven months after the enactment of the Biologics Price Competition and …
By John A. Gilbert & Karla L. Palmer – On October 12th, President Obama signed into law the “Combat Methamphetamine Enhancement Act of 2010” (Public Law No: 111-268) (“Enhancement Act”). The Enhancement Act amends the Controlled Substances Act by requiring all regulated retail sellers of certain …
By Kurt R. Karst – Hot off the presses! The U.S. Department of Justice (Solicitor General of the United States) filed its highly anticipated amicus brief in response to the U.S. Supreme Court’s invitation to weigh in on generic drug preemption. The Court’s request was made in the context …
By Carrie S. Martin – On October 25, 2010, FDA issued a draft guidance entitled “Qualification Process for Drug Development Tools.” This draft guidance describes a new qualification process for drug development tools (“DDTs”), which include, among other things, biomarkers and patient reported outcome instruments. The …
By Peter M. Jaensch – Over the last seven months, officials at FDA, including the FDA Commissioner, Margaret Hamburg, MD, and the Deputy Chief Counsel for Litigation, Eric Blumberg, have been promising to resume use of the individual criminal liability doctrine known as the Park Doctrine …
By Jennifer B. Davis – Earlier this week, the Government Accountability Office (“GAO”) publicly released its September 2010 Report to the House Committee on Oversight and Government Reform concerning Drug Safety, titled “DRUG SAFETY – FDA Has Conducted More Foreign Inspections and Begun to Improve Its …
By Ricardo Carvajal – FDA announced that its Pediatric Advisory Committee will meet on December 6 to “obtain and discuss information and data that will provide the Agency with a better understanding of current practices, and potential benefits and risks associated with the donation and banking …
On Thursday, United Therapeutics Corporation (“UTC”), a biotechnology company focused on the development and commercialization of unique products to address the unmet medical needs of patients with chronic and life-threatening conditions, unveiled a plaque honoring HP&M Director Frank Sasinowski for his contributions to UTC’s development …
By Kurt R. Karst – Company submissions to the Securities and Exchange Commission (“SEC”) can be a valuable source of information. Consider, for example, a recent quarterly report from Celgene Corporation, which states with respect to Risk Evaluation and Mitigation Strategies (“REMS”) that: In the fourth quarter …
By Kurt R. Karst – Some Senate Democrats have joined their Republican colleagues in voicing opposition to the inclusion of the “Preserve Access to Affordable Generics Act” (S. 369) in the Fiscal Year 2011 Financial Services and General Government Appropriations Bill (S. 3677). As we previously …
By Dara Katcher Levy – How many lawsuits will it take before FDA starts exercising better judgment on imports? On October 25, 2010, Amphastar Pharmaceuticals Inc. (“Amphastar”) filed suit against FDA seeking declaratory judgment and injunctive relief with regard to FDA’s detention of two entries of …
