By Kurt R. Karst – Consistent with recent wins concerning generic PROGRAF (tacrolimus) and generic ZOSYN (piperacillin sodium; tazobactam sodium) Injection (here and here), the U.S. District Court for the Central District of California recently ruled that FDA’s April 2008 denial of a citizen petition and decision …
By Ricardo Carvajal – In an unusual step, FDA and FTC have issued a joint warning letter to the internet marketer of a dietary supplement promoted as helpful in preventing swine flu, seasonal flu, and colds. According to the letter, the product “has not been …
By John R. Fleder – Numerous states have filed lawsuits across the country alleging that pharmaceutical companies have defrauded the Medicaid system by “publishing” inflated prices, namely “AWP” and “WAC” prices, that do not accurately reflect the prices at which those companies actually sell their products. …
Beginning on October 20, Stoel Rives LLP will present a three-part webinar on “business and legal issues related to the development of environmentally sustainable food products.” The titles and dates for the sessions are: Session 1: Where to Start? Developing and Financing Sustainable Food Products (Tuesday, …
By Kurt R. Karst – On October 14, 2009, Sens. Jeanne Shaheen (D-NH) and David Vitter (R-LA) announced the introduction of S. 1778, the Access to Affordable Medicines Act. The bill would amend the FDC Act’s ANDA provisions at § 505(j) to add a new …
By Douglas B. Farquhar – In the second day of the Enforcement and Litigation Conference sponsored by the Food and Drug Law Institute (“FDLI”), speakers from FDA and private industry discussed the trends in international trade in FDA-regulated products, and debated when companies are required …
By Douglas B. Farquhar – At the FDA Enforcement and Litigation Conference sponsored by the Food and Drug Law Institute ("FDLI"), the Compliance Directors of three of FDA's Centers, representatives of other components of the Food and Drug Administration, and a Justice Department official today forecast …
On October 27, 2009, the European Food Law Association (“EFLA”) will hold its first international EU-US Food Law Conference at the Brussels Sofitel, Place Jourdan 1 – 1000, Brussels. EFLA is an international scientific association whose primary goal is to study and to promote Food …
By Ricardo Carvajal – FDA has issued a draft guidance document that addresses FDCA section 201(rr)(4), which prohibits a tobacco product from being “marketed” in combination with any other FDA-regulated product. The guidance provides the following as an example of prohibited conduct: "Nicotine that is derived …
By Kurt R. Karst – In what could shape up to be a very interesting (and important) precedent, the U.S. District Court for the Eastern District of Michigan (Southern Division) recently ruled and issued an Order and Injunction requiring Novo Nordisk, Inc. (“Novo”) to change an Orange …
By Ricardo Carvajal & Susan J. Matthees – When the Federal Trade Commission (FTC) sought comments in 2008 on proposed revisions to its Guides Concerning the Use of Endorsements and Testimonials in Advertising, we noted that endorsers (including expert endorsers and celebrities) and bloggers should beware. …
By Susan J. Matthees – FDA recently announced two new developments related to its review of proprietary name submissions. First, FDA announced the availability of a new manual of policies and procedures (“MAPP”), MAPP 6720.2: Procedures for Handling Requests for Proprietary Name Review, that details the …
By Alan M. Kirschenbaum – Last Friday the Senate Finance Committee completed its mark-up of the “America’s Healthy Future Act of 2009.” The Committee is awaiting scoring by the Congressional Budget Office before it votes on the bill this week. Earlier we reported on the original …
By Kurt R. Karst – Last week, the U.S. District Court for the District of New Hampshire ruled in a 67-page opinion that various state law tort claims brought against generic drug manufacturer Mutual Pharmaceutical Company, Inc. (“Mutual”) are not preempted by Title I of the …
By William T. Koustas – FDA recently issued its most extensive guidance for industry regarding Risk Evaluation and Mitigation Strategies (“REMS”) since their enactment of the Food and Drug Administration Amendments Act of 2007 (“FDAAA”). The “Draft Guidance for Industry: Format and Content of Proposed …
