• where experts go to learn about FDA
    • FDA Advisory Committee Gives a “Thumbs-Up” to PROVENGE Cancer VaccineMarch 30th, 2007

      Yesterday, FDA’s Cellular, Tissue and Gene Therapies Advisory Committee voted in favor of Dendreon Corp.’s PROVENGE (sipuleucel-T), an autologous active cellular immunotherapy intended to treat men with asymptomatic metastatic androgen independent prostate cancer.  The committee unanimously voted (17-0) that PROVENGE is reasonably safe for the intended …

    • FDA Issues Draft Final Guidance Document on Fresh-Cut Fruits and Vegetables HazardsMarch 30th, 2007

      In FDA’s “Guide to Minimize Microbial Food Safety Hazards of Fresh-Cut Fruits and Vegetables,” FDA states that Americans are eating more fresh produce, to the point that fresh-cut products are the produce industry’s “fastest growing segment.”  Fresh-cut food processors are now faced with the task …

    • Amlodipine Besylate Exclusivity Issues – the FDA FrontMarch 28th, 2007

      The Federal Circuit’s March 22, 2007 decision invalidating Pfizer’s patent on NORVASC (amlodipine besylate), and Mylan’s commercial launch of its generic version approved under ANDA #76-418 later that day triggering the company’s 180-day exclusivity period has set off a flurry of activity, both in the …

    • Deficit Reduction Act of 2005 False Claims Act Education Requirements Are Not Applicable to Pharmaceutical ManufacturersMarch 28th, 2007

      The Deficit Reduction Act of 2005 (“DRA”) provided that any entity that receives or makes annual payments under a Medicaid State plan of at least $5,000,000 must, as a condition of receiving such payments, establish written policies for employees, contractors, and agents that provide detailed …

    • Senate Appropriations Committee Votes to Increase Rebates for Brand Name Products under the Medicaid Drug Rebate ProgramMarch 26th, 2007

      On March 22, 2007, the Senate Appropriations Committee approved S. 965, a bill making emergency appropriations primarily for the wars in Iraq and Afghanistan.  During the Committee’s consideration of the bill, it adopted an amendment offered by Senator Dick Durbin (D-IL) regarding the Medicaid Program.  …

    • 180-Day Exclusivity Forfeiture – A Zen MomentMarch 26th, 2007

      As the backlog of pre-Medicare Modernization Act (“MMA”) ANDAs is cleared and disputes over 180-day exclusivity under the old statutory regime become a vestige of the past, new post-MMA disputes over 180-day exclusivity will certainly take their place, particularly as they concern forfeiture.  Indeed, within …

    • FDA Law Blog in the News . . .March 23rd, 2007

      Although we launched this blog only two weeks ago, word is spreading fast that FDA Law Blog is a valuable source of information on timely and often overlooked issues affecting FDA-regulated industries.  Today, FDA Week, an industry publication from Inside Washington Publishers, ran an article …

    • WLF Weighs in on FDA Draft Guidances on Laboratory TestsMarch 23rd, 2007

      The Washington Legal Foundation (WLF), a public-interest law and policy center, has challenged FDA’s authority to regulate laboratory developed tests (LDTs), as well as FDA’s proposed method of changing its regulations governing analyte specific reagents (ASRs), which are components of LDTs.  LDTs are commonly referred …

    • FDA Issues Draft Guidance on New Advisory Committees Membership ProceduresMarch 21st, 2007

      Earlier today, FDA announced the availability of a draft guidance document “that would implement a more stringent approach for considering potential conflicts of interest for its advisory committee members and for recommending eligibility for meeting participation.”  The new guidance document, once finalized, will replace a …

    • Petition Seeks FDA’s “Forced Switch” of ALLEGRA and ZYRTEC to OTC StatusMarch 20th, 2007

      On March 12, 2007, Greenberg Traurig submitted a citizen petition to FDA to switch four prescription antihistamine and antihistamine-decongestant drugs from prescription to OTC status.  The four drugs are ALLEGRA (fexofenidine HCl), ALLEGRA D (fexofenidine HCl; pseudoephedrine HCl), ZYRTEC (cetirizine HCl), and ZYRTEC D (cetirizine …

    • Medicare Revokes Payment for ARANESPMarch 19th, 2007

      Reacting to a February 2007 FDA safety alert on the off-label use of erythropoietic stimulating agents (ESAs), Noridian Administrative Services (Noridian), a Medicare Administrative Contractor for 13 states in the west and midwest, announced that, effective March 5, 2007, Medicare will deny payment for the …

    • Data Quality Act Case May have Broader Implications on FDAMarch 16th, 2007

      In a case that may have wider implications for the data on which FDA bases its decisions, a medical marijuana rights group, Americans for Safe Access (ASA), has sued HHS and FDA for violating the requirements under the Data Quality Act, 44 U.S.C. § 3516 …

    • Abigail Alliance v. von EschenbachMarch 15th, 2007

      On March 1, 2007, the District of Columbia Circuit Court of Appeals heard an oral argument in Abigail Alliance v. von Eschenbach.  Previously, a divided court of appeals had ruled that where there are no other FDA-approved treatment options, a terminally ill patient’s access to …

    • FDA’s Proposed PDUFA IV Recommendations Would Eliminate the 505(b)(2) Application User Fee ExceptionMarch 14th, 2007

      FDA’s highly anticipated PDUFA IV proposal, if enacted by Congress, would eliminate any possibility that a 505(b)(2) application might not be an application subject to PDUFA user fees.  Among various technical changes included in the Agency’s PDUFA IV proposal, FDA recommends that Congress “[s]implify the …

    • FDA’s Response to a Petition Does Not Constitute Final Agency Action When the Petitioner Requests FDA’s ReconsiderationMarch 13th, 2007

      In July 2004, the Coalition for Mercury-Free Drugs (the Coalition) filed a citizen petition with FDA requesting that the agency prohibit the use of thimerosal and other mercury compounds in vaccines and drugs.  In August 2006, the Coalition went to court claiming that FDA had …