By Dara Katcher Levy – We previously blogged about the Amphastar lawsuit – a suit seeking declaratory judgment and injunctive relief with regard to FDA’s detention of two entries of semi-purified heparin. Amphastar had responded to each of FDA's allegations, however, the shipments remained detained. On November …
By Kurt R. Karst – In our post last week on letters issued by the U.S. Patent and Trademark Office (“PTO”) clarifying when patents covering certain drug products are eligible for a Patent Term Extension (“PTE”) in light of the U.S. Court of Appeals for the Federal …
By Dara Katcher Levy – The government is surely persistent when it comes to imported products that relate to FDA. On November 2, 2010, the U.S. Court of International Trade denied the U.S.’s application for a default judgment of $17,734,926 against a British corporation that many years …
By Alan M. Kirschenbaum – The Centers for Medicare & Medicaid Services (“CMS”) has finalized the withdrawal of its regulations on the calculation of Average Manufacturer Price (“AMP”) and the determination of federal upper limits. As we previously reported, CMS is withdrawing these regulations because they …
By Ricardo Carvajal – The graphic artists working on behalf of FDA have been busy, busy, busy! The agency posted 36 proposed graphic health warnings that would accompany the new health warning statements required under section 201 of the Family Smoking Prevention and Tobacco Control Act. …
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 …
