• where experts go to learn about FDA
    • Court Rejects FDA’s Interpretation of “Affiliate” in PDUFA User Fee Case As Contrary To Plain LanguageDecember 14th, 2009

      By Nisha P. Shah & Michelle L. Butler – We recently blogged about an action commenced by Winston Laboratories, Inc. (“Winston”) against FDA, which denied a small business waiver for a new drug application (“NDA”) user fee under the Prescription Drug User Fee Act.  See …

    • Court Dismisses Lawsuit over FDA’s Ban of Flavored Rolling PapersDecember 13th, 2009

      By Ricardo Carvajal – FDA has prevailed on summary judgment in a lawsuit brought by BBK Tobacco & Foods, LLP ("BBK") which sought a declaration that separately sold flavored rolling papers are not tobacco products subject to regulation under the FDCA.  Previously, FDA issued a draft …

    • FDA Publishes Guidance on Liquid Dietary Supplements and Beverages and Issues Warning LettersDecember 10th, 2009

      By Susan J. Matthees & A. Wes Siegner – Last week FDA published a new guidance document titled “Guidance for Industry:  Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and other Conventional Foods.”  The guidance document includes a …

    • Myriad Amendments to Senate Health Care Reform Bill Aimed at Generic DrugsDecember 10th, 2009

      By Kurt R. Karst –       Although much discussion has been devoted over the past few days to Sen. Byron Dorgan’s (D-ND) proposed amendment (SA 2793) to the Senate Health Care Reform Bill that would let U.S. pharmacies and drug wholesalers import FDA-approved drugs from certain …

    • GAO Finds Continued Need for FDA Drug Postmarket Safety Oversight Improvement; Seeks Timeline for Transfer of Certain Protocol Reviews from OND to OSEDecember 10th, 2009

      By Jamie K. Wolszon – The U.S. Government Accountability Office (“GAO”) released a report earlier this week finding that FDA’s postmarket drug safety decision-making and oversight, while improved since a prior investigation a few years ago, continues to have gaps.  The GAO recommended that FDA …

    • PTO Rules on the Availability of Multiple Interim Patent Term ExtensionsDecember 9th, 2009

      By Kurt R. Karst –       A recent decision from the Patent and Trademark Office (“PTO”) in which the Office granted an interim Patent Term Extension (“PTE”) for U.S. Patent No. 5,407,914 but denied interim extensions for U.S. Patent Nos. 5,260,273 and 5,789,381 covering the drug product …

    • What FDA’s Action on Caffeinated Alcoholic Beverages Could Mean for GRASDecember 7th, 2009

      By Ricardo Carvajal – When FDA sent letters to manufacturers of caffeinated alcoholic beverages asking them to furnish evidence supporting a conclusion that the use of caffeine in an alcoholic beverage is generally recognized as safe (GRAS) or prior sanctioned, the agency allowed 30 days …

    • Court of Appeals Affirms Dismissal of Off-Label Marketing CaseDecember 7th, 2009

      By John R. Fleder – On December 4, 2009, the United States Court of Appeals for the Eleventh Circuit in Atlanta issued a 24-page Opinion in James Hopper v. Solvay Pharmaceuticals, Inc., No. 08-15810.  The Court affirmed the District Court’s dismissal of a False Claims Act …

    • DoD Loses a Battle but Wins the War on TRICARE Retail RefundsDecember 6th, 2009

      By Alan Kirschenbaum − We previously reported on a March 2009 Department of Defense (DoD) regulation establishing a prescription drug “refund” program to implement section 703 of the National Defense Authorization Act of 2008 (NDAA 08).  That section provides that prescriptions filled on or after January …

    • Court Issues Opinion in Red Flags Rule Lawyers Case That May Have Broader Applicability to Other BusinessesDecember 4th, 2009

      By William T. Koustas – We previously reported that the United States District Court for the District of Columbia ruled in favor of the American Bar Association and prevented the Federal Trade Commission ("FTC") from enforcing its Red Flags Rule (“the Rule”) on attorneys.  On …

    • FDA Proposes Timetable for Review of Modified Risk Tobacco ProductsDecember 3rd, 2009

      By Ricardo Carvajal – FDA has issued a draft guidance that proposes a “preliminary” timetable for the agency’s review of applications for approval of modified risk tobacco products (MRTP’s).  FDCA section 911(a) prohibits the introduction of an MRTP into interstate commerce unless FDA has issued …

    • WLF Supports Allergan’s Challenge to FDA’s Policies on Off-Label SpeechDecember 2nd, 2009

      By Carrie S. Martin –       On November 19, the Washington Legal Foundation (“WLF”), along with three other organizations, filed an amicus curiae brief in support of Allergan, Inc.’s First Amendment challenge to FDA’s ban on “truthful, accurate and nonmisleading speech” proactively disseminated to health care …

    • You Like Us, You Really Like Us!December 1st, 2009

      Thanks to our faithful readers, we made the list for the Third Annual ABA Journal Blawg 100.  One of our readers, an FDA official, said that “there is no one within the agency that does what this blog provides.”  We are humbled by this honor and hope …

    • Settlement in False Claims Act Suit is no bar to suing the ConsultantDecember 1st, 2009

      By Jeffrey N. Wasserstein – We missed this interesting decision in the run-up to Thanksgiving.  Now that we’ve recovered from our tryptophan-induced sleepiness, we found this case to be of particular interest.  We previously blogged on the Cell Therapeutics Inc. (“CTI”) case.  To sum up …