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    Year: 2012

    • DEA Proposes Disposal Regulations Addressing the “Medicine Cabinet” SyndromeDecember 31st, 2012

      By Larry K. Houck – The Drug Enforcement Administration (“DEA”) published its long awaited notice of proposed rulemaking to implement the Secure and Responsible Drug Disposal Act of 2010 (“Disposal Act”).  77 Fed. Reg. 75,784 (Dec. 21, 2012).  Interested persons should submit electronic comments on …

    • Are Food Allergen Thresholds on the (Far) Horizon?December 27th, 2012

      By Ricardo Carvajal – Signaling potential movement on an issue that has bedeviled industry, FDA published a notice requesting comments “relevant to conducting a risk assessment to establish regulatory thresholds for major food allergens.”  Undeclared major food allergens continue to be one of the two principal …

    • Your Dog as a Medical Device?December 26th, 2012

      By Jennifer D. Newberger & Jeffrey N. Gibbs – A quick Google search of “dog trained to identify medical conditions” indicates that, around the world, dogs are already working with people to help sniff out certain medical conditions.  For example, in the United Kingdom an organization …

    • When is Yogurt Not Yogurt? Judge Lets FDA DecideDecember 25th, 2012

      By Riëtte van Laack – District Judge Susan Nelson of the District of Minnesota recently concluded that FDA is best qualified and has been authorized by Congress to decide whether Milk Protein Concentrate (“MPC”) is a “proper, permitted ingredient in yogurt.”  Earlier this year, on March …

    • HP&M’s Diane McColl Tapped as New President of the International Society for Regulatory Toxicology and PharmacologyDecember 25th, 2012

      Hyman, Phelps & McNamara, P.C. is pleased to announce that Diane B. McColl has been elected to serve as the new President of the International Society of Regulatory Toxicology and Pharmacology (“ISRTP”).  ISRTP’s mission is to provide an open public forum for policy makers and …

    • DEA Proposes Controlling Lorcaserin in Schedule IVDecember 21st, 2012

      By Larry K. Houck – The Drug Enforcement Administration (“DEA”) published a notice of proposed rulemaking in the December 19th Federal Register (77 Fed. Reg. 75,075 (Dec. 19, 2012)) to place lorcaserin into schedule IV of the federal Controlled Substances Act (“CSA”).  Interested persons must …

    • HP&M’s Dave Clissold to Speak at Management Forum Conference on Drug Regulatory Strategy MattersDecember 21st, 2012

      Hyman, Phelps & McNamara, P.C. Director David B. Clissold will be speaking at an upcoming Management Forum conference on myriad topics, including orphan drug exclusivity, FDA regulatory strategies, and advanced therapy products.  The conference, titled “EU and US Regulatory Issues for IP Professionals,” will take …

    • Trade Groups Sue Alameda County Over Drug Take-Back and Disposal OrdinanceDecember 19th, 2012

      By Kurt R. Karst –       The Pharmaceutical Research and Manufacturers of America (“PhRMA”), the Biotechnology Industry Organization (“BIO”), and the Generic Pharmaceutical Association (“GPhA”) share some common ground.  All three of the trade groups oppose a Safe Drug Disposal Ordinance (see here and here [Item …

    • FDA Releases Draft Guidance on Enrichment Strategies for Clinical TrialsDecember 18th, 2012

      By Alexander Varond – On December 14, FDA released a draft guidance document entitled “Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products” (“Enrichment Guidance”).  The thirty-nine-page document was more than six years in the making and aims to provide …

    • In a Milestone for Regulation of Imported Foods, New Zealand and U.S. Food Safety Systems are Deemed ComparableDecember 18th, 2012

      By Ricardo Carvajal – FDA announced that it executed a Food Safety Systems Recognition Arrangement ("RA") with its counterpart in New Zealand, the Ministry for Primary Indsutries ("PMI").  The RA is the culmination of an assessment that began in 2010 and included both paper and on-site …

    • “No-AG” Agreements are Not “Reverse Payments” Subject to Antitrust Scrutiny Says District Court in LAMICTAL LitigationDecember 17th, 2012

      By Kurt R. Karst –       Excitement over the U.S. Supreme Court’s recent decision to hear Federal Trade Commission v. Watson Pharmaceuticals, Inc. (Docket No. 12-416), a drug patent settlement agreement (a.k.a. “reverse payment” or “pay-for-delay agreement”) case involving ANDROGEL (testosterone gel) (see our previous post …

    • Support Appears to be Growing to Delay the Medical Device TaxDecember 13th, 2012

      By Carmelina G. Allis – Earlier this month, the IRS published final regulations and interim guidance on the excise tax imposed on the sale of certain medical devices intended for human use pursuant to the Health Care and Education Reconciliation Act of 2010 and the Patient Protection …

    • “Carcinogen-Free” Label Program Proposed in House BillDecember 12th, 2012

      By Etan Yeshua – Manufacturers of foods, drugs and cosmetics might possibly be able to label their products as “Carcinogen-Free” with federal approval.  In November, Rep. Theodore Deutch (D-FL) and Rep. Sue Myrick (R-NC) introduced the "Carcinogen-Free Label Act of 2012" (H.R. 6601), which would …

    • A Deep Dive Into the Second Circuit’s Caronia Decision, Potential Next Steps, and Potential Enforcement FalloutDecember 12th, 2012

      As we promised in an earlier post, we provide here a deeper analysis of the Second Circuit’s holding in United States v. Caronia and the context in which it should be viewed by industry. Since the 2004 Warner-Lambert settlement, the federal government has investigated hundreds …

    • In Litigation, FDA Explains and Defends FSMA EffortsDecember 11th, 2012

      By Ricardo Carvajal – We previously reported on a lawsuit that seeks to compel OMB and FDA to accelerate the implementation of FSMA.  Now the government has filed a motion to dismiss the case and for summary judgment.  The motion provides a full accounting of …

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