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In This Issue  Product Safety  Product Approvals  Opportunities for comment and/or recently published guidances:  Announcements  Upcoming meetings  Resources	Volume 1 | Number 6  | May 18, 2011 Product Safety FDA Drug Safety Communication: Connection problems involving certain needleless pre-filled glass syringes containing adenosine and amiodarone FDA is alerting the healthcare community about syringe connection problems when certain needleless glass syringes containing the cardiac drugs adenosine and amiodarone are used with particular types of intravenous (IV) access systems. More Information FDA, FTC act to remove fraudulent STD products from the market FDA and the Federal Trade Commission (FTC) announced a joint effort to remove products from the market that make unproven claims to treat, cure, and prevent sexually transmitted diseases (STDs). Among the products targeted are Medavir, Herpaflor, Viruxo, C-Cure, and Never An Outbreak. More information Bristol-Myers Squibb Initiates a Nationwide Voluntary Recall of Coumadin® (Warfarin Sodium) Crystalline 5 mg Tablets, Lot Number 9H49374A Bristol-Myers Squibb initiated a voluntary recall of one lot of 1,000-count bottles of Coumadin® (warfarin sodium) Crystalline 5 mg tablets. Bottles of 1,000 tablets are distributed to pharmacies for further dispensing to patients in prescription quantities. The lot number affected in the U.S. is 9H49374A with an expiry date of September 30, 2012. The recall is a precautionary measure based on the company’s testing of tablets from a returned bottle. A single tablet was found to be higher in potency than expected. More information Defibtech Announces a Voluntary Recall of DDU-100 series AEDs Defibtech, LLC is initiating a worldwide voluntary recall of certain DDU-100 series semi-automatic external defibrillators (AEDs) sold under the Lifeline AED and ReviveR AED brand names, including 65,885 AEDs distributed in the United States. This recall affects only DDU-100 Series AEDs shipped with 2.004 software or earlier. This corrective action addresses two possible conditions, which in rare cases may cause an affected AED to cancel shock during the charging process and not provide therapy which may result in failure to resuscitate the patient. Both conditions are not detectable by the periodic self test. More information For more product safety information, please visit our MedWatch website.   Product Approvals FDA approves Victrelis for Hepatitis C On May 13, 2011, FDA approved Victrelis (boceprevir) the first direct acting antiviral to treat certain adults with chronic hepatitis C. Victrelis is used for patients who still have some liver function, and who either have not been previously treated with drug therapy for their hepatitis C or who have failed such treatment. Victrelis is approved for use in combination with peginterferon alfa and ribavirin. More information FDA clears first test to quickly diagnose and distinguish MRSA and MSSA FDA cleared the first test for Staphylococcus aureus (S.aureus) infections that is able to quickly identify whether the bacteria are methicillin resistant (MRSA) or methicillin susceptible (MSSA). More information FDA expands approved use for carotid stent FDA approved an expanded indication that will allow a new group of patients at risk of stroke due to clogged neck arteries to be treated with the RX Acculink carotid stent. More information FDA approves new treatment for rare type of pancreatic cancer FDA approved Afinitor (everolimus) to treat patients with progressive neuroendocrine tumors located in the pancreas (PNET) that cannot be removed by surgery or that have spread to other parts of the body (metastatic). More information FDA approves new treatment for Type 2 diabetes FDA approved Tradjenta (linagliptin) tablets, used with diet and exercise, to improve blood glucose control in adults with Type 2 diabetes. More information FDA approves Zytiga for late-state prostate cancer FDA approved Zytiga (abiraterone acetate) in combination with prednisone (a steroid) to treat patients with late-stage (metastatic) castration-resistant prostate cancer who have received prior docetaxel (chemotherapy). More information For information on drug approvals or to view drug labeling, please visit Drugs@FDA.   Opportunities for comment and/or recently published guidances: FDA requests input on development of user fee program for biosimilar and interchangeable biological products FDA is requesting input from stakeholders and the public relating to the development of a user fee program for biosimilar and interchangeable biological product (351(k)) applications. More information Examination of Online Direct-to-Consumer Prescription Drug Promotion This notice solicits comments on a series of studies, Examination of Online Direct-to-Consumer Prescription Drug Promotion. These studies are designed to test different ways of presenting benefit and risk information in online direct-to-consumer (DTC) prescription drug Web sites. Comments due June 27, 2011. More information Generic Drug User Fee; Public Meeting; Request for Comments/Notice of Public Meeting FDA is announcing a public meeting to provide a public update and to gather additional stakeholder input on the development of a generic drug user fee program. Meeting will take place at the White Oak Campus on May 10, 2011. Comments due June 10, 2011. More information Draft Guidance for Industry and FDA Staff: Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling; Availability FDA is announcing the availability of the draft guidance document entitled ‘‘Draft Guidance for Industry and FDA Staff: Processing/ Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.’’ The recommendations in this guidance are intended to improve the safety and effectiveness of devices with processing or reprocessing labeling. This draft guidance is not final; nor is it in effect at this time. Comments due by August 1, 2011. More information Periodic Review of Existing Regulations; Retrospective Review Under Executive Order. 13563 In accordance with Executive Order 13563, ‘‘Improving Regulation and Regulatory Review,’’ FDA is conducting a review of its existing regulations to determine, in part, whether they can be made more effective in light of current public health needs and to take advantage of and support advances in innovation. Comments due June 27, 2011. More information Draft Guidance for Industry: Testing for Salmonella Species in Human Foods and Direct-Human-Contact Animal Foods The purpose of this guidance is to address testing procedures for Salmonella species (Salmonella spp.) in human foods and direct-human-contact animal foods, and the interpretation of test results, when the presence of Salmonella spp. in the food may render the food injurious to human health. More information User Fee Waivers, Reductions, and Refunds for Drug and Biological Products This guidance provides recommendations to applicants regarding requests for waivers, refunds, 18 and reductions of user fees assessed under sections 735 and 736 of the Federal Food, Drug, and 19 Cosmetic Act (the Act) for drugs, including biological drug products. This guidance is a revision 20 of the draft guidance entitled Draft Interim Guidance Document for Waivers of and Reductions 21 in User Fees (1993 interim guidance), issued July 16, 1993. More information Announcements FDA issues final guidance for liquid OTC drug products with dispensing devices FDA released its final guidance to firms that manufacture, market, or distribute over-the-counter (OTC) liquid drug products packaged with cups, droppers, syringes, and spoons to measure and dispense the doses of medication. More information FDA issues first new rules under Food Safety Modernization Act FDA announced two new regulations that will help ensure the safety and security of foods in the United States. The rules are the first to be issued by the FDA under the new authorities granted the agency by the FDA Food Safety Modernization Act (FSMA), signed into law by President Obama in January. Both rules will take effect July 3, 2011. More information FDA Looks to improve design and cleaning instructions for reusable medical devices FDA announced steps to help reduce the risk of exposure to improperly reprocessed devices that can lead to the transmission of disease. More information Upcoming meetings FDA advisory committee meetings are free and open to the public. No prior registration is required to attend. Interested persons may present data, information, or views, orally at the meeting, or in writing, on issues pending before the committee. Please contact the "contact person" listed for each meeting for more information about how to submit comment, testimony or other information. ____________ Allergenic Products Advisory Committee Meeting DATE:  May 12, 2011 TIME:  8:00 a.m. to 3:30 p.m. LOCATION:  Doubletree Hotel,  8120 Wisconsin Avenue, Bethesda, MD  20814 CONTACT:  Gail Dapolito or Jane Brown Phone: 301-827-0314, E-mail: gail.dapolito@fda.hhs.gov; sheryl.clark@fda.hhs.gov The committee will receive updates and have discussion on the following topics:  (1) Structure and Activities of the Laboratory of Immunobiochemistry, Division of Bacterial, Parasitic, and Allergenic Products, Center for Biologics Evaluation and Research, FDA; (2) enzyme-linked immunosorbent assay replacement of radial immunodiffusion assays for potency determinations of cat and ragweed pollen allergen extracts by the Laboratory; (3) statistical considerations for the design and interpretation of phase III clinical trials of allergenic products; (4) environmental exposure chambers for phase III studies of allergenic products, and (5) International Organization for Standardization 17025 accreditation of the Laboratory. Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting DATE:  May 12, 2011 TIME:  8:00 a.m. to 6:00 p.m. LOCATION:  Hilton Washington DC North/Gaithersburg, Salons A, B, C, and D, 620 Perry Pkwy., Gaithersburg, MD 20877 CONTACT:  Margaret McCabe-Janicki, Phone: 301-796-7029 The committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Augment Bone Graft, sponsored by Biomimetic Therapeutics, Inc.  Pediatric Advisory Committee Meeting DATE: May 16, 2011 TIME: 8:00 a.m. to 3:00 p.m. LOCATION: Hilton Washington DC/Silver Spring, The Ballrooms, 8727 Colesville Rd., Silver Spring, MD  CONTACT: Walter Ellenberg, Ph.D., Phone: 301–796-0885, E-mail: walter.ellenberg@fda.hhs.gov The Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (Public Law 107-109) and the Pediatric Research Equity Act (Public Law 110-85) for Bepreve, Besivance, Cetraxal, Patanase Spray, Astepro Spray, Crestor, Welchol, Intuniv, Lexapro, Actonel, Hiberix, and Valcyte. The committee will also receive further followup on Topical Calcineurin Inhibitors: Elidel and Protopic. The Pediatric Advisory Committee will hear and discuss the recommendation of the Pediatric Ethics Subcommittee from its meeting on May 11, 2011, regarding the Institutional Review Board process for clinical investigations that involve both an FDA regulated product and research involving children as subjects that is conducted or supported by HHS. Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee Meeting DATE: May 17-18, 2011 TIME: Day 1: 8:00 a.m. to 5:00 p.m. Day 2: 8:00 a.m. to 12:00 noon LOCATION: Hilton Washington DC/Silver Spring, The Ballrooms, 8727 Colesville Rd., Silver Spring, MD CONTACT: Diem-Kieu Ngo, Pharm.D., BCPS, Phone: 301-796-9001, E-mail: diem.ngo@fda.hhs.gov On May 17 and 18, 2011, the committees will review pertinent pharmacokinetic, safety and efficacy data, and discuss whether new dosing information for oral over-the-counter (OTC) drug products containing acetaminophen should be added to the label for children less than 2 years of age. In addition, the committees will consider adding a weight-based dosing regimen to the existing age-based dosing regimen for children 2 to 12 years of age. Dosing for children 12 years of age and older will not be discussed. Lastly, the committees will discuss ways that administration by caregivers can be improved so that medication errors can be minimized. Science Board Advisory Committee; Notice of Meeting DATE: May 20, 2011 TIME: 9:00 a.m. to 4:00 p.m. LOCATION: FDA White Oak Campus, Building 31, The Great Room (Room 1503) White Oak Conference Center, 10903 New Hampshire Avenue, Silver Spring, Maryland CONTACT: Martha Mosner, 301-796-4627 The Science Board provides advice primarily to the Commissioner of Food and Drugs and other appropriate officials on specific complex and technical issues, as well as emerging issues within the scientific community in industry and academia. Cellular, Tissue and Gene Therapies Advisory Committee Meeting DATE: May 31, 2011 TIME: 2:30 p.m. to 6:15 p.m. LOCATION: National Institutes of Health Campus, 29 Lincoln Drive, Building 29B, Conference Rooms A and B, Bethesda, MD 20892 CONTACT: Gail Dapolito or Sheryl Clark , 301-827-0314, E-mail: gail.dapolito@fda.hhs.gov; sheryl.clark@fda.hhs.gov On May 31 from 2:30 p.m. to approximately 6:15 p.m., the Committee will meet by teleconference. In open session, the committee will hear brief overviews of research programs in the Laboratory of Biochemistry, Division of Therapeutic Proteins, Center for Drug Evaluation and Research; and the Laboratory of Cell Biology, the Laboratory of Molecular and Developmental Immunology, the Laboratory of Molecular Oncology, Division of Monoclonal Antibodies, Center for Drug Evaluation and Research, FDA. From approximately 5:15 p.m. to 6:15 p.m., the meeting will be closed to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c) (6)). The committee will discuss a report of intramural research programs and make recommendations regarding personnel staffing decisions. Reprocessing of Reusable Medical Devices; Public Workshop DATE: June 8 and June 9, 2011 TIME: 8:30 a.m. to 5:30 p.m. LOCATION: FDA White Oak Campus, Building 31, The Great Room (Room 1503) White Oak Conference Center, 10903 New Hampshire Avenue, Silver Spring, Maryland CONTACT: Carol Krueger, 301-796-3241, E-mail: carol.krueger@fda.hhs.gov FDA is announcing a public workshop entitled: ‘‘Reprocessing of Reusable Medical Devices Workshop.’’ The purpose of the workshop is to discuss factors affecting the reprocessing of reusable medical devices and FDA’s plans to address the identified issues. Workshop dates are June 8-9, 2011. Proposal to Withdraw Approval for the Breast Cancer Indication for Bevacizumab (Avastin); Hearing DATE: June 28 and June 29 TIME: 8 a.m. to 5 p.m. LOCATION: FDA White Oak Campus, Building 31, The Great Room (Room 1503) White Oak Conference Center, 10903 New Hampshire Avenue, Silver Spring, Maryland The Food and Drug Administration (FDA) is granting a hearing to Genentech, Inc. (Genentech), on the Center for Drug Evaluation and Research’s (CDER’s) proposal to withdraw approval of the breast cancer indication for bevacizumab (Avastin). Genentech is the sponsor for Avastin. Genentech and CDER are the parties to the hearing. The issues to be discussed and resolved at the hearing relate directly to the statutory and regulatory standard for FDA to withdraw accelerated approval of the metastatic breast cancer (MBC or breast cancer) indication for Avastin. Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting DATE: June 29, 2011 TIME: 8:00 a.m. to 6:00 p.m. LOCATION: Holiday Inn, Ballroom, 2 Montgomery Village Ave., Gaithersburg, MD CONTACT: Shanika Craig, 301-796-6639 The committee will discuss and make recommendations regarding the possible reclassification of molecular diagnostics for the rapid detection of Mycobacterium tuberculosis complex and the detection of genetic mutations which confer antibiotic resistance in M. tuberculosis complex. Discussion would include the appropriate information and acceptable performance characteristics that would be required to assess the safety and effectiveness of rapid diagnostic tests for M. tuberculosis complex, and whether these can be sufficiently specified to support possible reclassification. Cellular, Tissue and Gene Therapies Advisory Committee Meeting Announcement DATE: June 29, 2011 TIME: 8:00 a.m. to 5:00 p.m. LOCATION: Crowne Plaza Hotel, 8777 Georgia Avenue, Silver Spring, MD 20910 CONTACT: Gail Dapolito or Sheryl Clark, 301-827-0314, E-mail: gail.dapolito@fda.hhs.gov; sheryl.clark@fda.hhs.gov The Committee will discuss cellular and gene therapy products for the treatment of retinal disorders. Topics to be considered include the following: (1) Efficacy endpoints in pediatric and adult populations, (2) potential safety issues related to repeat administration or second eye administration, and (3) evaluation of product delivery into target site.     Please visit FDA’s Advisory Committee page to obtain advisory committee meeting agendas, briefing materials, and meeting rosters prior to the meetings.  You may also visit this page after meetings occur to obtain transcripts, presentations, and voting results.  For additional information on other agency meetings please visit Meetings, Conferences, & Workshops. Resources MedWatch Safety Alerts for Human Medical Products Your FDA gateway for finding clinically important safety information and reporting serious problems with human medical products. Device Use Safety Tips Medical Device Safety Tips highlight what can go wrong if labeling is overlooked or not followed, and provide advice on how to mitigate risks. FDA Patient Safety News FDA Patient Safety News is a televised series that features information on new drugs, biologics and medical devices, on FDA safety notifications and product recalls that, while geared for health care providers, may be interesting and informative to patients. FDA Basics Each month, different Centers and Offices at FDA will host an online session where the public can ask questions to senior FDA officials about a specific topic or just listen in to learn more about FDA.