• where experts go to learn about FDA
    • Anne Northrup to be Nominated as CPSC CommissionerJuly 31st, 2009

      Yesterday, President Obama announced that he intends to nominate Anne Northrup as a Commissioner of the Consumer Product Safety Commission.  Anne Northrup was a Congresswoman from Kentucky from 1997-2006.  As we previously reported, earlier this month, Inez Moore Tenenbaum was sworn in as the ninth …

    • House Passes Food Safety Enhancement Act of 2009July 30th, 2009

      By Ricardo Carvajal – The U.S. House of Representatives has passed the Food Safety Enhancement Act of 2009, which would substantially strengthen FDA’s regulatory authority over foods.  The bill would grant FDA mandatory recall authority, expanded access to records, stronger seizure and administrative detention authorities, …

    • FTC Extends Deadline for Red Flags RuleJuly 29th, 2009

      By William T. Koustas –       Today, the FTC announced that it is delaying enforcement of the controversial Red Flags Rule (“the Rule”) until November 1, 2009.  The FTC press release states that it is extending the August 1, 2009 deadline, previously discussed in this blog, …

    • False Advertising Claim under Lanham Act Not Precluded or Barred by the FDC ActJuly 28th, 2009

      By Cassandra A. Soltis – In Pom Wonderful LLC v. Ocean Spray Cranberries, Inc., 2009 WL 2151355 (C.D. Cal. 2009), the U.S. District Court for the Central District of California determined that Pom Wonderful LLC’s (Pom’s) false advertising claim against Ocean Spray Cranberries, Inc. (Ocean …

    • FDA Finalizes Authorized Generics Reporting Rule; Electronic Submissions Will be Permitted and Eventually RequiredJuly 27th, 2009

      By Kurt R. Karst –       On July 28, 2009, FDA will publish a final rule amending the Agency’s regulations requiring that NDA holders submit in annual reports certain information to the Agency concerning authorized generics.  The regulations, which were first proposed in September 2008 – …

    • So What Does “Reasonable Probability of Serious Adverse Health Consequences or Death” Really Mean?July 24th, 2009

      By Ricardo Carvajal –       On July 23, FDA held the first of three public workshops to explain the Reportable Food Registry requirements that will take effect on September 8, 2009.  One thing was made clear: the agency has no plans to offer a definition of …

    • Two Synthes Inc. Execs Enter Guilty PleasJuly 22nd, 2009

      By Carmelina G. Allis – We previously reported that Synthes, Inc., Norian Corporation, and four of Synthes’s executives had been charged by the United States government for allegedly violating several provisions of Titles 18 and 21 of the United States Code.  The defendants allegedly conducted clinical …

    • United States v. Farinella: Vindicated on Appeal – It Does HappenJuly 21st, 2009

      Hyman, Phelps & McNamara’s John R. Fleder has written an article in the July/August 2009 edition of the Food and Drug Law Institute’s Update Magazine.  The article is entitled: “Vindicated on Appeal – It Does Happen.”  The article discusses a recent ruling in United States …

    • First FDA-Approved REMS for an OpioidJuly 20th, 2009

      By William T. Koustas – Last week, FDA announced the approval of Onsolis (fentanyl buccal soluble film) with a substantial Risk Evaluation and Mitigation Strategy ("REMS"), as well as a boxed warning.  Onsolis is a potent opioid that is administered through the mucous membranes of …

    • Senate Passes Bill Further Amending the CMEA (Our 600th FDA Law Blog Post!)July 19th, 2009

      By John A. Gilbert & Larry K. Houck – The Senate recently passed S. 256 which places additional requirements on retailers that sell ephedrine and pseudoephedrine.  The bill, known as the “Combat Methamphetamine Enhancement Act of 2009,” was referred to the House (H.R. 2923), which …

    • IFT Publishes Expert Report on Making Decisions About the Risks of Chemicals in Foods with Limited Scientific InformationJuly 17th, 2009

      By Ricardo Carvajal – The Institute of Food Technologists (“IFT”) has published an expert report that addresses the challenge of responding to food contamination events in the face of limited scientific information.  The report describes the U.S. legal framework that governs substances intentionally or inadvertently …

    • CIFOR Publishes Guidelines for Foodborne Disease Outbreak ResponseJuly 17th, 2009

      By Ricardo Carvajal – The Council to Improve Foodborne Outbreak Response (“CIFOR”) has published guidelines intended to help local, state and federal agencies improve their response to foodborne disease outbreaks. The guidelines address planning and preparation, surveillance and outbreak detection, investigation of clusters and outbreaks, …

    • DOJ Switches Position and Narrows The Playing Field for Reverse Payments in Hatch-Waxman SettlementsJuly 16th, 2009

      By JP Ellison – The amicus brief recently filed by the Department of Justice’s (“DOJ”) Antitrust Division makes it clear that at least on the issue of so-called “reverse payments” the antitrust lawyers at DOJ agree with their colleagues at the Federal Trade Commission (“FTC”) …

    • FDA Shows That It’s Serious About Food Allergen GMPsJuly 15th, 2009

      By Ricardo Carvajal –       In a complaint filed on July 1, the government is asking a federal district court to enjoin certain manufacturers of protein powder mixes and dietary supplements from further marketing of products alleged to be adulterated under FDC Act section 402(a)(4) due to the …

    • Senate HELP Committee Passes Amendment for 12-Year Biologics Exclusivity PeriodJuly 14th, 2009

      By Kurt R. Karst –       Following the introduction of several proposals last week, as well as a proposal from Senator Sherrod Brown (D-OH), the U.S. Senate Health, Education, Labor, and Pensions (“HELP”) Committee voted 16-7 late Monday night in favor of a proposal offered by Sens. …