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    • 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 …

    • 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 …

    • 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 …

    • 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.” 

    • More Information about Nevada Compliance Program LawJuly 6th, 2007

      A colleague of your trusted bloggers spoke with counsel for the Nevada Board of Pharmacy (“BOP”) and reports the following about the new law in our post from yesterday: A draft regulation will be posted on the BOP website next week.  BOP welcomes comments on the …

    • New Nevada Law Requires Companies to Adopt a Marketing Code of ConductJuly 5th, 2007

      On June 14, 2007, Nevada Governor Jim Gibbons signed into law Assembly Bill 128, which is similar to the drug marketing compliance law that went into effect in California in July 2005.  Nevada’s new law, which goes into effect on October 1, 2007, requires a …

    • Supreme Court Addresses Degree of Deference Owed to “Gap-Filling” Government Regulations and InterpretationsJune 26th, 2007

      Earlier this month, the Supreme Court issued its unanimous decision in Long Island Care At Home, Ltd. v. Coke, a case concerning compensation for in-home caregivers and the Department of Labor’s (“DOL’s”) interpretation of the Fair Labor Standards Act (“FLSA”).  The Court’s decision, although anticipated, …

    • West Virginia Prescription Drug Advertising Expense Reporting Rule RevisedMay 23rd, 2007

      West Virginia continues to move forward with implementing its prescription drug advertising expense reporting law.  On April 24, the West Virginia Secretary of State filed the West Virginia Pharmaceutical Cost Management Council’s revised emergency rule for Prescription Drug Advertising Expense Reporting.  The rule will go …

    • U.S. Senate Passes Omnibus FDA Reform BillMay 11th, 2007

      Earlier this week, the U.S. Senate passed S. 1082, the “Food and Drug Administration Revitalization Act” (“FDARA”) by a vote of 93-1 (Sen. Bernie Sanders (I-VT) was the lone “nay” vote).  The bill is an omnibus FDA reform and user fee package that, among other …

    • HPM Announces Forum on FDA Device Regulation & Medicare Device Reimbursement, June 6, Research Triangle Park, NCMay 9th, 2007

      The Council for Entrepreneurial Development will hold a “MedTech” forum on June 6, 2007 in Research Triangle Park, NC to discuss FDA’s regulation of medical devices and device reimbursement under the Medicare program.  HPM’s own Marc Shapiro will moderate the program.  Jeff Gibbs and Kirk …

    • HPM Announces New DirectorMay 1st, 2007

      Hyman, Phelps & McNamara, P.C. is very pleased to announce that Jeffrey K. Shapiro has joined the firm as a director. Prior to joining the firm, Mr. Shapiro was a partner at Hogan & Hartson. Mr. Shapiro’s practice focuses primarily on assisting medical device and …

    • HPM Announces New AssociateApril 19th, 2007

      Hyman, Phelps & McNamara, P.C. is pleased to announce that Carrie S. Martin has joined the firm as an associate.  Ms. Martin earned a law degree with honors from The George Washington University Law School in 2004. She served as an Articles Editor for the …

    • Is Advice Provided by Food and Drug Lawyers Legal Advice Protected from Discovery?April 2nd, 2007

      A recent California case, In re CV Therapeutics, Inc. Securities Litigation, raised the question of whether, within the context of the attorney-client privilege, regulatory advice provided by food and drug attorneys qualifies as “legal” (protected) advice or “business” (generally not protected) advice.  The court concluded …