By Ricardo Carvajal - Although many of the Food Safety Modernization Act's ("FSMA's") major provisions have a delayed effective date (including the requirement to develop and implement a HACCP plan), some significant provisions will take immediate effect, including: Stronger records access authority (FSMA § 101). FDA gains authority …
By John A. Gilbert & Karla L. Palmer - The Drug Enforcement Administration announced earlier this week that it is holding a public meeting to discuss with interested persons procedures for the surrender of unwanted controlled substances by ultimate users and long term care facilities. The …
By Wes Siegner – On December 20, 2010 FDA published a notice requesting comments on how the agency can address a “problem” that has existed since the 1960s, when the Federal Food, Drug, and Cosmetic Act ("FDC Act") was amended in to require premarket approval. The problem …
By Riëtte van Laack – In a short, unpublished decision issued on December 10, 2010, the D.C. Circuit denied a petition filed by Daniel Chapter One and James Fejio (“DCO”) seeking review of an FTC cease and desist order. The FTC Order, issued in 2009, concluded …
As expected, the U.S. House of Representatives passed the Food Safety Modernization Act (H.R. 2751) as passed by the Senate. The bill now goes to the President, who is expected to sign it into law. A copy of the bill is available here (scroll down to …
By Kurt R. Karst – In a recent citizen petition submitted to FDA, Sandoz Inc. (“Sandoz”) requests from the Agency a written decision that Cobrek Pharmaceuticals, Inc. (“Cobrek”), the alleged “first applicant” for a generic version of HECTOROL (doxercalciferol) Injection, has forfeited 180-day exclusivity eligibility. The …
By Alan M. Kirschenbaum – Exclusion from Medicare and Medicaid is a potent weapon used by the government against program-related fraud, but it can be a double edged sword when wielded against drug and medical device companies. Exclusion of a drug or device company means that …
By Jeffrey N. Wasserstein – As our loyal blog readers know, we are great fans of social media, and follow these topics in earnest (here, here, and here). We have just learned that the long-awaited FDA guidance that was promised to come out by year-end will …
By Jamie K. Wolszon – Hyman, Phelps & McNamara, P.C. Directors Douglas B. Farquhar and John R. Fleder presented a webinar on Monday December 20, 2010 for Thompson Interactive entitled: “Are Attorneys the FDA’s New Enforcement Target?” The webinar slides can be found here. The …
By JP Ellison – In Dickens’ A Christmas Carol, the main character is visited by three ghosts who by scaring him with visions of his past, present and future, seek to change him. On December 13, 2010, in the form of a U.S. District Court for …
By Ricardo Carvajal – Capping a week-long flurry of legislative activity, the Senate reportedly passed the Food Safety Modernization Act by a voice vote Sunday night. The legislation now returns to the House, where approval is likely. Given that the President’s signature is certain, it now appears …
By Riëtte van Laack – On December 15, 2010, FDA took several steps to increase its enforcement against products that are marketed as dietary supplements but contain analogs of, or the same active ingredients as, FDA-approved drugs, or other substances that do not qualify as dietary …
By Ricardo Carvajal – The massive spending bill to which food safety legislation was attached (and that also includes provisions on rare and neglected diseases) – the Fiscal Year 2011 Omnibus Appropriations Act – has been pronounced dead. Although Congress may yet find another vehicle for …
Hyman, Phelps & McNamara, P.C.’s Ricardo Carvajal will be presenting "Food Safety: Unintended Components/Contaminants of Food" at the Food and Drug Law Institute's ("FDLI’s") January 24-25, 2011 conference, "Introduction to Food Law and Regulation: How the Government Regulates the Food Industry," which is part of FDLI’s Food Week …
By Ricardo Carvajal – FTC announced a proposed settlement with Dannon over the latter’s allegedly deceptive advertising claims for two of its probiotic products, Activia and DanActive. FTC’s complaint alleged that Dannon explicitly or implicitly represented that one serving of Activia relieved temporary irregularity and helped …
