• where experts go to learn about FDA
    • Medicis Challenges FDA’s Policy on Hatch-Waxman Benefits for Combination Drugs Containing an “Old” AntibioticApril 27th, 2007

      On April 20, 2007, Arnold & Porter submitted a citizen petition and a petition for stay of action on behalf of Medicis Pharmaceutical Corp. asking FDA to change the Agency’s policy with respect to Hatch-Waxman patent and exclusivity benefits for combination drugs containing a so-called …

    • FDA Warning Letter Confirms DDMAC Focus on Accurate Presentation of Safety Information and Comparative ClaimsApril 25th, 2007

      On April 20, 2007, FDA’s Division of Drug Marketing, Advertising, and Communications (“DDMAC”) issued a Warning Letter to Alcon Laboratories, Inc. concerning the company’s promotion of CIPRODEX (ciprofloxacin, 0.3%; dexamethasone, 0.1%) Sterile Otic Suspension in a retail sell sheet and a sales aid.  FDA approved …

    • D.C. Court of Appeals Sidesteps Issue of FDA Classification of Dental Amalgam DevicesApril 24th, 2007

      On April 13, 2007, the U.S. Court of Appeals for the District of Columbia ruled in Moms Against Mercury v. FDA that the court lacks subject matter jurisdiction to decide whether FDA should classify “pre-amendment” Encapsulated Amalgam Alloy and Dental Mercury (“EAADM”) devices.  The Petitioners, …

    • U.S. ex rel. James Marchese v. Cell Therapeutics, Inc.April 23rd, 2007

      On April 16, 2007, Cell Therapeutics, Inc. (“CTI”) agreed to pay $10.5 million to resolve allegations of the company’s illegal marketing of TRISENOX (arsenic trioxide), a prescription drug indicated for treatment of refractory or relapsed acute promyelocytic leukemia.  The case arose out of a complaint …

    • Report Assesses the Impact of Authorized Generics on Paragraph IV Patent CertificationsApril 19th, 2007

      On April 18, 2007, Analysis Group, Inc. announced the release of a report assessing the effects of the market entry of authorized generics on paragraph IV patent certifications.  FDA has described an authorized generic as “[a]ny marketing by an NDA holder or authorized by an …

    • 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 …

    • FDA Decides Not to Approve Additional Amlodipine ANDAs at This TimeApril 18th, 2007

      Earlier today, FDA issued its decision with respect to amlodipine generics and the applicability of Mylan’s 180-day exclusivity and Pfizer’s pediatric exclusivity.  The U.S. District Court for the District of Columbia in Mylan v. Leavitt had ordered FDA to respond to Mylan’s TRO motion by …

    • Groups Challenge FDA’s PLAN B ApprovalApril 18th, 2007

      On April 12, 2007, the Association of American Physicians & Surgeons (“AAPS”), Concerned Women for America, Family Research Council, and Safe Drugs For Women filed a complaint in the U.S. District Court for the District of Columbia against FDA seeking declaratory and injunctive relief concerning …

    • FDA Proposes Revision to Labeling of Irradiated Foods & Dietary SupplementsApril 16th, 2007

      On April 4, 2007, FDA published proposed regulations for the labeling of irradiated foods and dietary supplements.  The proposed revisions are in response to the Farm Security and Rural Investment Act of 2002, which directed FDA to propose changes to the current regulations at 21 …

    • CMS Issues Draft Clinical Research PolicyApril 12th, 2007

      On April 10, 2007, CMS issued a draft of its revised Clinical Trial Policy, renamed Clinical Research Policy.  The draft policy was issued after CMS’s consideration of public comments on the agency’s July 10, 2006 coverage tracking sheet announcing the reconsideration of the September 19, …

    • GAO Issues Report to Aid in MDUFMA ReauthorizationApril 11th, 2007

      The Government Accountability Office (“GAO”) recently released a report detailing the revenue information from certain companies that participate in the Medical Device User Fee Program (“MDUFMA”).  MDUFMA authorizes FDA to charge user fees to review applications for the clearance or approval of medical devices.  MDUFMA …

    • Amlodipine Update . . . .April 10th, 2007

      Last week, we reported on several citizen petitions submitted to FDA by Mylan and Pfizer concerning the availability and applicability of 180-day exclusivity and pediatric exclusivity to amlodipine drug products.  FDA has also established a separate docket to solicit the views of interested parties on …

    • Crossing the Line: Kickbacks Come Under Increased Government ScrutinyApril 9th, 2007

      During the past several years, government enforcement authorities have focused an increasing amount of attention on the marketing activities of medical device companies.  This increased scrutiny has taken the form of investigations through subpoenas and intervention in qui tam lawsuits (lawsuits initiated by a third …

    • Orphan Drug User Fees – The Unintended Gift that Keeps on GivingApril 5th, 2007

      “Orphan drugs” are products recognized by FDA that are intended for use in a “rare disease or condition” ─generally a disease or condition with a United States prevalence less than 200,000 persons.  Because the market for orphan drugs is often limited, Congress and FDA have …

    • U.S. District Court Rules on FDA Ephedra RulemakingApril 4th, 2007

      On March 16, 2007, the U.S. District Court for the District of Utah ruled that FDA’s 2004 rulemaking banning ephedrine alkaloid dietary supplements [EDS] was “procedurally and substantively proper.”  Nutraceutical and Solaray brought the suit against FDA to prevent the Agency from enforcing its 2004 …