• where experts go to learn about FDA
    • Smaller Cigarette Manufacturers Challenge Constitutionality of FDA’s Restriction on Certain Product NamesApril 30th, 2010

      By Ricardo Carvajal – Some smaller cigarette manufacturers have sued FDA to invalidate a provision in FDA’s recently issued final rule that would restrict a manufacturer from using certain product names on the ground that the restriction violates the First and Fifth Amendments, among other …

    • Voluntary Front-of-Pack Food Labeling: A Way to Combat the Obesity Epidemic?April 27th, 2010

      By Cassandra A. Soltis – That’s what the Food and Drug Administration (“FDA”) is hoping anyway.  In a notice expected to be published in the Federal Register on Thursday, April 29, 2010, FDA will announce that it is requesting data and information from “all interested parties,” …

    • NAD Takes a Crack at BioavailabilityApril 26th, 2010

      By Cassandra A. Soltis – In an advertising challenge brought by the Perrigo Company (“Perrigo”), the National Advertising Division (“NAD”) of the Better Business Bureau recommended that Pharmavite, LLC (Pharmavite) refrain from making several claims for its Nature Made® Prenatal + DHA Liquid Softgel Vitamins …

    • FTC Annual Report Highlights the Commission’s Patent Settlement EffortsApril 25th, 2010

      By Kurt R. Karst –    Last Friday, at the American Bar Association’s Section of Antitrust Law Spring Meeting in Washington, D.C., Federal Trade Commission (“FTC”) Chairman Jon Leibowitz issued the FTC’s 2010 Annual Report.  Among other things, including allegedly false or unsupported claims concerning dietary …

    • FDA to Increase Oversight of Home Use Medical DevicesApril 22nd, 2010

      By Nisha P. Shah – FDA recently issued a white paper revealing that the Agency intends to strengthen its review of medical devices for home use, such as hemodialysis equipment, wound therapy care, intravenous therapy devices, and ventilators, as more hospital patients are being discharged …

    • A Not So Sweet 16 for FDA and PDUFA!April 21st, 2010

      By Kurt R. Karst –    Last Friday, several days after FDA held a meeting on the public’s assessment of the overall performance of the fourth iteration of the Prescription Drug User Fee Act (“PDUFA”), which was reauthorized as Title I of the 2007 FDA …

    • Advocacy Groups Ask FDA to Further Crack Down on Marketed Unapproved DrugsApril 20th, 2010

      By Kurt R. Karst –    In recent weeks, two advocacy groups have sent letters to FDA requesting that the Agency enhance and accelerate its enforcement activities with respect to marketed unapproved drugs.  FDA began its current Unapproved Drugs Initiative in June 2006 when the …

    • District Court Decision Sidesteps 30-Month Stay Tolling Issue; Denies Patent Infringement Litigation StayApril 19th, 2010

      By Kurt R. Karst –    The U.S. District Court for the District of Delaware’s recent decision in Millennium Pharmaceuticals, Inc. v. Teva Parenteral Medicines, Inc., denying a stay of patent infringement proceedings concerning generic versions of Schering’s INTEGRILIN (eptifibatide) Injection is (to our knowledge) the …

    • The Lanham Act: A Tool to Enforce the FDC Act?April 15th, 2010

      The March/April 2010 issue of FDLI Update contains an article by Hyman, Phelps & McNamara, P.C.’s Peter M. Jaensch and John R. Fleder that addresses the increasing number of cases brought under the federal Lanham Act law where plaintiffs have arguably sought to privately enforce the …

    • Federal Circuit Reverses District Court Decision in Patent Delisting Counterclaim Case; All Orange Book Information is Not “Patent Information”April 15th, 2010

      By Kurt R. Karst –    Earlier this week, the U.S. Court of Appeals for the Federal Circuit issued its decision in Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd., No. 2010-1001, interpreting the patent delisting counterclaim provisions at FDC Act §505(j)(5)(C)(ii)(I), as added by …

    • FDA Sued by Animal Rights Advocates and Ear (Holistic) Candle AdvocatesApril 14th, 2010

      By Kurt R. Karst – It seems to be a popular headline these days: “FDA Sued Over [take your pick].”  Following the frenetic losartan 180-day litigation – which is still not over, as FDA has filed a petition for panel rehearing and rehearing en banc …

    • FDA Denies Citizen Petition to Amend OTC Monograph for Healthcare Antiseptic Drug ProductsApril 13th, 2010

      By Susan J. Matthees – By letter of March 26, 2010, FDA denied a 2003 Citizen Petition from CTFA (now PCPC) and The Soap and Detergent Association which had requested FDA to include antiviral indications, labeling, and test methods in the Tentative Final Monograph ("TFM") …

    • Rulings Issued in Two Unrelated Lawsuits Challenging FDA’s Authority Under Section 361 of the PHS ActApril 12th, 2010

      By Jennifer B. Davis – (1) Regenerative Sciences, Inc. v. FDA.  On March 26, 2010, Chief Judge Wiley Y. Daniel of the United States District Court for the District of Colorado dismissed on “ripeness” grounds a February 22, 2009 action brought by Colorado-based Regenerative Sciences, Inc. …

    • PLAIRs – What are They and What are FDA’s Current Policies?April 11th, 2010

      By Kurt R. Karst –    Since 2008, FDA’s annual guidance document agendas (here, here, and here) have noted FDA’s plans to issue guidance on the Agency’s so-called Pre-Launch Activities Importation Request (“PLAIR”) program.  Although FDA officials have discussed PLAIRs in presentations, the Agency has not …

    • OIG Calls for Increased FDA Food Inspections and Expanded PenaltiesApril 8th, 2010

      By Ricardo Carvajal – The Office of Inspector General ("OIG") of the U.S. Department of Health and Human Services released a report that finds fault with FDA’s inspection activities for food facilities and recommends several changes, including an expansion of FDA’s statutory authority.  OIG reviewed FDA's food …