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    • FDA Takes Several Steps to Strengthen the Advisory Committee Process, Including Adopting Simultaneous VotingNovember 16th, 2007

      Late last week, FDA announced several steps intended to strengthen the advisory committee process.  The announced improvements are part of a broader FDA effort to address recommendations made by the Institute of Medicine in its September 2006 report, titled "The Future of Drug Safety: Promoting …

    • Rep. DeLauro Requests that FDA Cease Activities to Create the Reagan-Udall FoundationNovember 5th, 2007

      Title VI of the recently-enacted FDA Amendments Act (“FDAAA”) amended the FDC Act to establish a non-profit corporation whose purpose is to advance FDA’s Critical Path Initiative to “modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety.”  (The …

    • HHS OIG Announces FY 2008 Work Plan; 9 New FDA Studies Identified, Including Clinical Trial Oversight and Off-Label PromotionOctober 30th, 2007

      The Department of Health and Human Services’ (“DHHS”) Office of Inspector General (“OIG”) recently announced its Fiscal Year 2008 Work Plan.  The OIG Work Plan, issued annually, sets forth various projects to be addressed during the coming fiscal year by the Office of Counsel to …

    • HPM Issues Detailed FDAAA Summary and AnalysisOctober 11th, 2007

      Earlier today, Hyman, Phelps & McNamara, P.C. issued its detailed summary and analysis of the recently-enacted FDA Amendments Act (“FDAAA”).  A copy of the summary and analysis is available here.  FDAAA reauthorizes several user fee and pediatric-related laws, and includes a host of new provisions, …

    • Senate Passes Omnibus FDA Reform LegislationSeptember 20th, 2007

      Late today, the U.S. Senate passed FDA reform legislation by unanimous consent.  The Senate vote follows the House’s action yesterday when it passed H.R. 3580, the FDA Amendments Act of 2007.  Earlier in the day there was some concern that the Senate vote on the …

    • An Agreement Has Been Reached – House and Senate Staff Negotiators Release “Staff Agreement” on Omnibus FDA Reform Legislation; a Vote is Expected SoonSeptember 19th, 2007

      House and Senate staff have reportedly reached an agreement on omnibus FDA reform legislation that would, among several other things, reauthorize the Prescription Drug User Fee Act (“PDUFA”) through fiscal year 2012.  Earlier today, a “staff agreement” (427 pages) and summary of the legislation was …

    • FDA Issues Final ASR Guidance Document – Ambiguities RemainSeptember 16th, 2007

      FDA announced on September 14, 2007 the release of a final guidance document pertaining to analyte specific reagents (“ASRs”), titled “Guidance for Industry and FDA Staff – Commercially Distributed Analyte Specific Reagents (ASRs):  Frequently Asked Questions” (“the ASR Guidance”).  A draft version of this guidance …

    • Managing Residual Risk – Words from the WiseAugust 22nd, 2007

      Hyman, Phelps & McNamara, P.C.’s Brian J. Donato cautioned companies about the dangers of “residual risk” while speaking at a recent conference on risk management sponsored by AdvaMed.  Medical Device & Diagnostic Industry reported on the speech in an August 2007 article.  Residual risk, which …

    • FDA Issues Second Draft Version of IVDMIA GuidanceJuly 25th, 2007

      FDA has released a new draft guidance for In Vitro Diagnostic Multivariate Index Assays (“IVDMIAs”).  The first version, which was released on September 7, 2006, attracted many critical comments.  The new draft seeks to address some (but not all) of those concerns. Creating a new …

    • Supreme Court to Hear Case Involving Scope of the Preemption Provision of the Medical Device AmendmentsJuly 8th, 2007

      On June 25, 2007, the Supreme Court agreed to hear Riegel v. Medtronic, Inc., which concerns whether the FDC Act preempts state tort claims regarding medical devices that entered the market pursuant to the Premarket Approval (“PMA”) process.  In 1996, the Supreme Court held in …

    • FDA Postponement of 2008 Annual Registration for All Registered Medical Device EstablishmentsJune 29th, 2007

      The FDA announced it is postponing the annual registration of medical device establishments for 2008. The agency said this is a temporary action and it expects to resume annual registrations in October or November 2007.  Establishments that are already registered for 2007 are valid until …

    • 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, …

    • 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 …

    • 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 …

    • 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 …