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    • DEA Final Rule on Issuing Multiple Schedule II Prescriptions Goes Into EffectDecember 27th, 2007

      The Drug Enforcement Administration’s (“DEA”) final rule allowing individual practitioners to issue multiple Schedule II prescriptions to individual patients to be filled sequentially went into effect on December 19, 2007.  The rule will allow practitioners to prescribe up to a 90-day supply of a Schedule …

    • Methadone HCl 40 mg Tablets Voluntarily Restricted to Narcotic Treatment Programs and HospitalsDecember 26th, 2007

      The Drug Enforcement Administration (“DEA”) recently issued an advisory announcing that as of January 1, 2008, manufacturers of methadone HCl 40 mg tablets have voluntarily agreed to limit distribution due to the reported increase of adverse events related to methadone.  This raises new issues for …

    • Court Enjoins Average Manufacturer Price RuleDecember 21st, 2007

      We previously reported that two pharmacy associations were challenging the implementation of a rule promulgated by the Centers for Medicare & Medicaid Services (“CMS”) setting forth how to calculate the Average Manufacturer Price (“AMP”), the new, and importantly lower, benchmark for pharmaceutical reimbursement by Medicaid.  …

    • Congress Poised to Revamp TRICARE Retail Pharmacy Rebate ProgramDecember 13th, 2007

      Department of Defense (“DoD”) authorization bills currently pending in Congress (both H.R. 1585 and S. 1547) contain authority for a new, mandatory TRICARE retail pharmacy rebate program.  TRICARE is the military’s health care program serving active duty service members, retirees, their families, survivors and certain …

    • FDA Issues Advance Notice of Proposed Rulemaking to Revise Nutrition Labeling; Action Commences Most Sweeping Food Labeling Effort Since 1993December 12th, 2007

      On November 2, 2007, FDA published an Advance Notice of Proposed Rulemaking (“ANPR”) to revise nutrition labeling requirements for foods and dietary supplements.  FDA’s ANPR commences perhaps the most sweeping food labeling modification effort since 1993, when FDA issued the nutrition labeling rules mandated by …

    • FDA Sets FY2008 DTC Television Ad User Fee Rate; Adequate Funding Seems LikelyDecember 11th, 2007

      Earlier today, FDA issued a Federal Register notice announcing the Fiscal Year 2008 user fee rate for advisory review of Direct-to-Consumer (“DTC”) Television advertisements for prescription drug and biological products. The advisory review fee for FY2008 will be $41,390 for each proposed television advertisement voluntarily submitted …

    • FDA and Rep. Waxman Forget a Little Thing Called the First Amendment.December 6th, 2007

      Late last week, a yet-to-be released FDA draft guidance on “Good Reprint Practices” was made public by Rep. Henry Waxman (D-CA). Waxman, on behalf of the Committee on Oversight and Government Reform, issued a letter to FDA strongly urging it to refrain from finalizing and …

    • FDA Proposes to Nix Use of Nutrient Content Claims for EPA and DHADecember 5th, 2007

      On Nov. 27, 2007, FDA published a proposed rule to restrict the use of nutrient content claims for the omega-3-fatty acids, alpha-linolenic acid (ALA), docosahexaenoic acid (DHA), and eicosapentaenoic acid (EPA). The Agency proposes to prohibit notified nutrient content claims for EPA and DHA and …

    • Supreme Court hears oral argument in Riegel v. Medtronic, Inc.December 4th, 2007

      We previously reported that the Supreme Court had agreed to hear the PMA device preemption case Riegel v. Medtronic, Inc. The status of the case was in question earlier this fall because of an untimely motion to substitute the correct party (following the death of …

    • Sentencing Commission to Consider Amendments to Food and Drug GuidelinesDecember 4th, 2007

      For the first time in over a decade, the United States Sentencing Commission (the “Commission”) is considering amending the Sentencing Guidelines that are applied to individuals and organizations convicted of criminal violations of the Federal Food, Drug, and Cosmetic Act (“FDCA”). See 72 Fed. Reg. …