• where experts go to learn about FDA
  • Enforcement

    • FDA Compliance Directors and Others Predict Where the FDA Spotlight Will ShineOctober 13th, 2009

      By Douglas B. Farquhar – At the FDA Enforcement and Litigation Conference sponsored by the Food and Drug Law Institute ("FDLI"), the Compliance Directors of three of FDA's Centers, representatives of other components of the Food and Drug Administration, and a Justice Department official today forecast …

    • InterMune CEO Convicted of Wire Fraud and Acquitted of FDC Act ChargeSeptember 30th, 2009

      By Jeff Wasserstein – We previously blogged on the effort by W. Scott Harkonen, the former CEO of InterMune, to dismiss an indictment for misbranding and fraud.  That effort was unsuccessful, and Mr. Harkonen was convicted after trial of one count of wire fraud.  He …

    • Will We See More Strict Liability Prosecutions?September 27th, 2009

      The latest FDLI Update article by Hyman, Phelps & McNamara, P.C.’s Jamie K. Wolszon and John R. Fleder explores the so-called “strict liability” criminal prosecution doctrine in FDA cases that largely derives from the 1975 U.S. Supreme Court case of United States v. Park.  FDA believes …

    • First Circuit Affirms Judge Saris’s AWP DecisionSeptember 24th, 2009

      By Douglas B. Farquhar –      In a 98-page decision filed on September 23rd, the United States Court of Appeals for the First Circuit affirmed the judgment of Boston federal court Judge Patti Saris awarding certain “Medigap” insurance companies, patients and third-party payors $13 million from …

    • Kevin Trudeau Finally Gets a Partial Victory against the FTCSeptember 11th, 2009

      By Cassandra A. Soltis – Regrow your hair.  Cure cancer.  Obtain a photographic memory.  These are just some of the claims that Kevin Trudeau, infomercial marketer extraordinaire, has made for various products over the years.  The Federal Trade Commission (“FTC”) is all-too-familiar with Mr. Trudeau …

    • Pfizer Reaches Record Settlement with Feds; Yes, That Is $2.3 Billion with a ‘B’September 2nd, 2009

      By Douglas B. Farquhar – Pharmaceutical manufacturer Pfizer has agreed to the largest drug marketing settlement yet – $2.3 billion (yes, that is “billion” with a “b”) to resolve claims originally brought by six whistleblowers that the firm illegally marketed four drugs – according to …

    • Court Orders $70 Million in Consumer Redress In Case Against Supplement MakersAugust 31st, 2009

      By JP Ellison & Ricardo Carvajal – A Massachusetts district court has ordered marketers of calcium and herbal  supplements touted as effective in preventing, treating, or curing diseases such as cancer, heart disease, and diabetes to pay $70 million in consumer redress.  The court’s order dated …

    • Court Denies FTC Motion to Hold Lane Labs in ContemptAugust 20th, 2009

      By Susan J. Matthees– The United States District Court for New Jersey recently denied a motion by the Federal Trade Commission (“FTC”) to hold Lane Labs-USA, Inc. (“Lane Labs”), Andrew Lane, and William Lane in contempt for allegedly violating a consent decree.  Lane Labs entered into …

    • Recent First Circuit Decision Discussing the False Claims Act’s “Many Moving Parts” Serves As a Reminder of the Statute’s ComplexityAugust 18th, 2009

      By JP Ellison – With the seemingly endless flow of news reports announcing yet another unsealed False Claims Act (“FCA”) case, and the regular announcement of FCA settlements for what would have only a few years ago been unheard of amounts, it is easy to …

    • Judge Upholds FTC Action in False Cancer Cures CaseAugust 13th, 2009

      By Susan J. Matthees – The Federal Trade Commission (“FTC”) recently announced that an Administration Law Judge (“ALJ”) upheld FTC’s charges against a company, Daniel Chapter One, and its officer, James Feijo, for making claims that its shark cartilage and herbal supplements prevent, treat, and …

    • Warning: Don’t Delay Submission of Your 483 ResponseAugust 12th, 2009

      By Carmelina G. Allis – The FDA has issued a Federal Register notice announcing a program that establishes a timeframe for the submission and agency review of responses to Form FDA-483s before the agency’s issuance of Warning Letters.  This announcement is in line with our …

    • New FDA Commish Brandishes Big Stick, Offers CarrotAugust 6th, 2009

      By Douglas B. Farquhar – In an August 6, 2009 speech at an event sponsored by the Food and Drug Law Institute, Margaret A. Hamburg, M.D., the new FDA Commissioner, promised to ratchet up enforcement by speeding up issuance of Warning Letters, reducing the amount of time that …

    • Two Synthes Inc. Execs Enter Guilty PleasJuly 22nd, 2009

      By Carmelina G. Allis – We previously reported that Synthes, Inc., Norian Corporation, and four of Synthes’s executives had been charged by the United States government for allegedly violating several provisions of Titles 18 and 21 of the United States Code.  The defendants allegedly conducted clinical …

    • United States v. Farinella: Vindicated on Appeal – It Does HappenJuly 21st, 2009

      Hyman, Phelps & McNamara’s John R. Fleder has written an article in the July/August 2009 edition of the Food and Drug Law Institute’s Update Magazine.  The article is entitled: “Vindicated on Appeal – It Does Happen.”  The article discusses a recent ruling in United States …

    • FDA Shows That It’s Serious About Food Allergen GMPsJuly 15th, 2009

      By Ricardo Carvajal –       In a complaint filed on July 1, the government is asking a federal district court to enjoin certain manufacturers of protein powder mixes and dietary supplements from further marketing of products alleged to be adulterated under FDC Act section 402(a)(4) due to the …