• where experts go to learn about FDA
    • The Lighter Side of Food & Drug LawJuly 30th, 2007

      Every so often something comes across our desk that is so comical that we feel compelled to share it with others in the food and drug community who will also appreciate it.  One such story comes from a case involving Biovail and FDA in the …

    • Interested in Learning the Latest about the Government’s Plans to Develop Countermeasures to Respond to CBRN Attacks and Pandemics?July 26th, 2007

      If so, the Department of Health and Human Services (“DHHS”) is convening a four day stakeholders workshop in Washington, D.C. beginning on July 31, 2007.  The purpose of the workshop is to enable stakeholders from government, industry, and academia to discuss the government’s plans to …

    • FDA Issues Second Draft Version of IVDMIA GuidanceJuly 25th, 2007

      FDA has released a new draft guidance for In Vitro Diagnostic Multivariate Index Assays (“IVDMIAs”).  The first version, which was released on September 7, 2006, attracted many critical comments.  The new draft seeks to address some (but not all) of those concerns. Creating a new …

    • CMS Takes Another Stab at Updating its Medicare Clinical Trial PolicyJuly 24th, 2007

      After a highly anticipated revision of Medicare’s Clinical Trial Policy (“CTP”) that was issued in a July 9, 2007 Decision Memorandum (“Proposed Decision”) left many scratching their heads, the Centers for Medicare & Medicaid Services (“CMS”) issued a Proposed Decision Memorandum for Second Reconsideration of …

    • Support for BioGenerics Legislation Is Falling Apart at the SeamsJuly 23rd, 2007

      Support for legislation that would create a biogenerics approval path is reportedly crumbling.  Last month, the Senate Health, Education, Labor, and Pensions (“HELP”) Committee passed S. 1695, “the Biologics Price Competition and Innovation Act of 2007.”  Although neither the full Senate, nor the House Energy …

    • Thinking of Marketing a Weight-Loss or Diet Product?July 19th, 2007

      Before you do, be sure to become familiar with the Federal Trade Commission’s (“FTC’s”) regulation of the advertising of such products.  Hyman, Phelps & McNamara attorneys Cassandra Soltis and John Fleder noted in an article for the Food and Drug Law Institute’s Update magazine that …

    • HPM Attorneys Present on False Claims Act Compliance StrategiesJuly 19th, 2007

      On Tuesday, July 17th, Hyman, Phelps & McNamara attorneys Michelle Butler and Jeff Wasserstein gave a teleconference, titled “False Claims Act Compliance Strategies: Don’t Lose Access to Medicare and Medicaid Reimbursement.”  Audio copies of the teleconference, along with a transcript of the witty, yet thoughtful, …

    • Bridging the Transatlantic Divide – FDA Announces Expanded Cooperation With European Food and Drug AuthoritiesJuly 18th, 2007

      Increasing cooperation between U.S. and European food and drug regulatory authorities are creating efficiencies for regulated industries and that benefit the public health.  In two recent press releases, FDA announced that the European Medicines Agency (“EMEA”) has agreed to expand current regulatory cooperation with the …

    • Highlights of the Final CMS Medicaid Rebate RuleJuly 16th, 2007

      On July 6, 2007, the Centers for Medicare & Medicaid Services (“CMS”) posted on its website a pre-publication copy of a final rule with a comment period to implement the Medicaid Rebate Program.  The regulation, which finalizes a proposal that was published in the Federal …

    • Overwhelmed by Public Comment, USDA Publishes Interim Final Rule Amending the NOP National ListJuly 15th, 2007

      We previously reported on a proposed rule issued by the U.S. Department of Agriculture (“USDA”) to amend the agency’s National Organic Program (“NOP”) regulations at 7 C.F.R. Part 205 to add 38 non-organic minor ingredients to the National List of Allowed and Prohibited Substances (“National …

    • House Passes Omnibus FDA Reform BillJuly 12th, 2007

      Late Wednesday, the House of Representatives passed, by a vote of 403-16, H.R. 2900, “the Food and Drug Administration Amendments Act of 2007.”  The Senate passed its version of omnibus FDA reform legislation in May 2007 — S. 1082, “the Food and Drug Administration Revitalization …

    • FDA is Asked for a Third Time About Orange Book Patent Listings for Drug Delivery SystemsJuly 12th, 2007

      For the third time in as many years, FDA has been requested to provide an advisory opinion on the Agency’s policy for the submission of patents for Orange Book listing that cover drug delivery systems (e.g., metered-dose and dry powder inhalers, and transdermal patches) that …

    • Orphan Drug Designation Not Sacrosanct – FDA Revokes Orphan Designation for TheraCLEC for EPI, but Other Exclusivity Issues RemainJuly 11th, 2007

      In a July 3, 2007 filing with the Securities and Exchange Commission (“SEC”), Altus Pharmaceuticals Inc. announced that the company was notified by FDA’s Office of Orphan Products Development (“OOPD”) that the orphan drug designation granted in January 2002 to ALTU-135, also know as TheraCLEC, …

    • FDARA: PET Drug User FeesJuly 10th, 2007

      Positron Emission Tomography drugs, or PET drugs (not to be confused with drugs approved for companion animals), would be accorded more equitable user fee status under PDUFA IV if the Senate-passed version of the FDA Revitalization Act (“FDARA”) is signed into law.  (A similar provision …

    • China Executes its Former Food and Drug ChiefJuly 10th, 2007

      From the New York Times: “China executed its former top food and drug regulator today for taking bribes to approve untested medicine as Beijing scrambled to show that it is serious about improving the safety of Chinese products.”