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    • Minnesota Lawmakers Send Letter to FDA with Concerns About the 510(k) ProcessNovember 30th, 2010

      By Jeffrey K. Shapiro & Carmelina G. Allis – FDA’s review of 510(k) program continues to cause concern in Congress.  On November 24, 2010, the Minnesota delegation, including unlikely collaborators Senator Al Franken and Representative Michele Bachmann, sent a letter to Dr. Hamburg asking “FDA to review …

    • U.S. Senate Advances Food Safety LegislationNovember 30th, 2010

      By Ricardo Carvajal – By a vote of 73 to 25 (see the roll call here), the Senate has passed S. 510, the Food Safety Modernization Act.  As we noted in a prior posting, the Senate HELP Committee released a compromise agreement in August that would …

    • A Repeat! ABA Journal Names FDA Law Blog to “Blawg 100”November 30th, 2010

        Thanks to our faithful readers, we made the list for the annual American Bar Association (“ABA”) Journal Blawg 100 for the second year in a row.  The editors of the ABA Journal announced the top 100 best law blogs by lawyers, for lawyers earlier this …

    • Legal Setbacks and Legislative Inaction May Push the FTC to Consider “Plan C” to Address Patent Settlement AgreementsNovember 29th, 2010

      By Kurt R. Karst –       Recent judicial setbacks for the Federal Trade Commission (“FTC’) in actions challenging patent settlement agreements (or what opponents call “pay-for-delay” or “reverse payment” agreements) and opposition from both Republicans and Democrats to the inclusion of the Preserve Access to Affordable Generics …

    • Rep. Slaughter Tells FDA That Triclosan Should Be Banned From Consumer ProductsNovember 25th, 2010

      By Susan J. Matthees – Congresswoman Louise Slaughter (D-NY) recently sent a letter to FDA Commissioner Margaret Hamburg requesting that FDA ban the use of triclosan in consumer products.  Triclosan is commonly used as an antibacterial agent in topical antiseptic products, such as soaps and hand …

    • Have a Happy (And Safe) ThanksgivingNovember 24th, 2010

      By Ricardo Carvajal – It’s the time of year for holiday food safety alerts.  The home kitchen has long been recognized as a significant source of foodborne illness.  Reliable data are hard to come by, but a recent survey and study suggest that consumer awareness and …

    • FDA and FTC Target Caffeinated Alcoholic Malt BeveragesNovember 23rd, 2010

      By Ricardo Carvajal & Diane B. McColl – FDA issued warning letters to the manufacturers of certain caffeinated alcoholic malt beverages contending that the products are adulterated under the Federal Food, Drug, and Cosmetic Act (“FDC Act”) because caffeine is not an approved food additive for …

    • Sandoz Attempts to Clear Up Post-Losartan “Bottleneck” with DJ Action on Disclaimed PatentNovember 22nd, 2010

      By Kurt R. Karst –       Sandoz Inc.’s recent Complaint filed in the U.S. District Court for the District of Columbia concerning Orange Book-listed U.S. Patent No. 7,429,602 (“the ‘602 patent”) covering ELESTAT (epinastine HCl) Ophthalmic Solution, could, if successful, serve as a model for future cases …

    • FDA Says There is No Scientific Evidence of Problems in Switching Bioequivalent Anti-epileptic Meds, But Further Study is WarrantedNovember 21st, 2010

      By Kurt R. Karst –       Last month FDA responded to an August 25, 2010 request from New Jersey State Senator Joseph F. Vitale (D) concerning pending legislation – Assembly Bill 1995 (the State Senate version of which is Senate Bill 961) – that, if enacted, would …

    • Publish and Perish: A Disturbing Trend in the European Union’s Regulation of Nutrition Health Claims Made on FoodsNovember 19th, 2010

      By Ricardo Carvajal – An article in the current edition of the Food and Drug Law Institute’s Update discusses a recent development in the European Union's regulation on health claims used in food labeling that could have the effect of suppressing publication of scientific research on …

    • Accelerate Your Understanding of Accelerated Approvals; Navigating The FDA Accelerated Approval ProcessNovember 19th, 2010

      On December 9, 2010, Hyman, Phelps & McNamara, P.C.’s Kurt R. Karst will speak at a webinar on accelerated drug and biologic approvals.  In 1992, FDA published final regulations providing for the “accelerated approval” of applications for certain new drugs and biologics. Section 506 of the …

    • Confirmation Hearing for Michele Leonhart, Proposed DEA AdministratorNovember 18th, 2010

      By William T. Koustas – The confirmation hearing for Michele M. Leonhart for the Administrator of the U.S. Drug Enforcement Administration (“DEA”) was held by the Senate Judiciary Committee on Wednesday, November 17, 2010.  Ms. Leonhart has been Acting DEA Administrator since the resignation of former …

    • District Court Grants FDA Motion to Dismiss in Unapproved Morphine Sulfate LitigationNovember 17th, 2010

      By Kurt R. Karst –       In a November 16th decision that might not mark the end to the dispute between Cody Laboratories, Inc. and Lannett Co., Inc. (collectively “Cody/Lannett”) and FDA over marketed unapproved Morphine Sulfate Solution Immediate-Release 20mg/mL drug products, Judge Alan Johnson from the …

    • FDA Files Amicus Brief on Generic Drug PreemptionNovember 16th, 2010

      By Kurt R. Karst –    Following up on a June 11, 2010 invitation from the U.S. Court of Appeals for the Sixth Circuit to file an amicus brief in the consolidated appeals of Smith v. Wyeth, Inc. (Case No. 09-5460), Wilson v. Pliva, Inc. (Case No. …

    • Generic Drug Industry Headed for a “180-Day Exclusivity Cliff”November 16th, 2010

      By Kurt R. Karst–       The generic drug industry is headed for its own version of a “patent cliff” – a “180-day exclusivity cliff” – according to a report from MorganStanley on large cap and specialty pharmaceuticals issued earlier this month.  “Patent cliff” is a colloquial term …