By Riëtte van Laack – On January 7, the FTC announced an initiative “Operation Failed Resolution” stating that it wants to protect consumers against deceptive weight loss claims. Among other things, the FTC announced actions against four companies for advertising fad weight-loss products, issued an updated …
By Kurt R. Karst – With primary briefing over (briefs here, here, and here), and a December 13, 2013 Oral Argument before Judges Griffith, Kavanaugh and Randolph concluded, we were waiting with bated breath for the U.S. Court of Appeals for the District of Columbia Circuit …
By Karla L. Palmer – FDA Commissioner Margaret A. Hamburg, M.D., sent open letters (here and here) to “Hospital Purchasers” and state officials including governors, state boards of pharmacy and health departments, informing them of the passage of the Drug Quality and Security Act (Public Law 113-54,127 …
By Ricardo Carvajal – As we noted in a prior posting, several courts have stayed or dismissed class actions based on the doctrine of primary jurisdiction in cases that raise the question of whether a GMO-containing food can properly be labeled as “natural.” In response to …
By Ricardo Carvajal – In the latest major rulemaking initiative under the Food Safety Modernization Act ("FSMA"), FDA issued a proposed rule to implement provisions of FSMA that address intentional adulteration. Further below we summarize major provisions of the proposed rule. However, we note at the outset …
By Kurt R. Karst – Sandoz Inc. (“Sandoz”) is appealing to the U.S. Court of Appeals for the Federal Circuit (Docket No. 14-1693) a November 2013 decision from the U.S. District Court for the Northern District of California granting Amgen Inc.’s (“Amgen’s”) and Hoffmann-La Roche Inc.’s …
By Alan M. Kirschenbaum – Hyman, Phelps & McNamara, P.C. has updated the firm’s outline on the Application of the Health Care Fraud and Abuse Laws to the Marketing of Pharmaceuticals and Medical Devices. The outline, which was last updated in 2009, has been expanded to …
By Kurt R. Karst – Last week, in an unusual move, the U.S. Court of Appeals for the Federal Circuit waded into non-patent territory when the Court issued its decision in Allergan, Inc. v. Athena Cosmetics, Inc. (Case No. 2013-1286), a consolidated appeal of several decisions …
By Dara Katcher Levy – Recently, a bill was introduced into the House of Representatives that would legalize personal importations and re-importations of certain foreign drugs. The Personal Drug Importation Fairness Act of 2013 (H.R. 3715) would allow Americans to buy prescription drugs from certain countries …
By Riëtte van Laack – On December 17, FDA published a proposal to amend the 1994 tentative final monograph (“TFM”) for OTC topical antimicrobial drug products, which addressed antiseptic healthcare products. The proposed rule concerns consumer antiseptic products intended for use with water, referred to as …
By JP Ellison – In early 2014, the Supreme Court will meet in conference to decide whether to hear a case concerning whether, and to what extent, a private party can pursue a Lanham Act claim based on labeling regulated under the FDC Act. The Court will …
By Kurt R. Karst – In a recent memorandum to Center for Drug Evaluation and Research (“CDER”) staff (reprinted below, and a condensed version of which was posted on FDA’s website, here), CDER Director Janet Woodcock, M.D. announced that the Department of Health and Human Services …
By Ricardo Carvajal – A California district court granted Defendants’ motion to dismiss in a putative class action brought by Plaintiffs who alleged that certain plant-based beverages, including soymilk, almond milk, and coconut milk, were misbranded because FDA defines “milk” as being derived from lactating cows. …
By Kurt R. Karst – There’s a hot debate brewing over whether or not a biosimilar biological product licensed under Section 351(k) of the Public Health Service Act (“PHS Act”), as added by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), should share the …
By Anne K. Walsh – With no fanfare, the U.S. Supreme Court on Monday denied a writ of certiorari in a case watched closely by the drug and device industry. As reported earlier, the former CEO of InterMune Inc., Scott Harkonen, had filed a petition asking the …
