FDA Updates for Health Professionals

October 5, 2016

UPDATES FOR HEALTH PROFESSIONALS Office of Health and Constituent Affairs ANNOUNCEMENTS OPPORTUNITIES FOR COMMENT / GUIDANCES PRODUCT APPROVALS & CLEARANCES PRODUCT SAFETY UPCOMING MEETINGS RESOURCES ANNOUNCEMENTS FDA warns against the use of homeopathic teething tablets and gels FDA is warning consumers that homeopathic teething tablets and gels may pose a risk to infants and children. The FDA recommends that consumers stop using these products and dispose of any in their possession. Homeopathic teething tablets and gels are distributed by CVS, Hyland’s, and possibly others, and are sold in retail stores and online. Consumers should seek medical care immediately if their child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using homeopathic teething tablets or gels. More information New Drug Info Rounds Video: Extortion Scams  Since 2008, hundreds of people who have purchased prescription drugs over the Internet or via telephone have unknowingly exposed themselves to extortion by individuals posing as FDA and DEA agents. In this short video, FDA pharmacists discuss how to handle and report an extortion call from a fake FDA agent. More information Making Sure ‘Healthy’ Means What It Says on Food Packages With final rules on the Nutrition Facts label published, consumers soon will see an updated label on food packages that makes the calories and serving sizes of products easier to see and that gives them additional nutrition information, such as added sugars, vitamin D, and potassium. The marketplace is teeming with rows and rows of foods – some new and some not; some healthier than others. Even for the well informed, choosing what to buy is challenging, especially if you want to choose a healthy diet for you and your families. More information FDA’s Clinical Investigator Training Helps Support the Drug Development Process Though many people do not know it, FDA does much more to facilitate drug approval than evaluate new drug applications. We are also actively involved in drug development well before the application stage. One important way we do this is by training scientists who conduct the clinical trials for drugs in development. This helps ensure that the drug studies conducted by investigators meet the applicable regulatory requirements and that the applications submitted meet regulatory standards.More information Using Symbols to Convey Information in Medical Device Labeling In June, FDA issued the Use of Symbols in Labeling final rule, which describes the circumstances in which manufacturers can use a stand-alone symbol in device labeling without any adjacent explanatory text. For example, if certain requirements are met under the final rule, manufacturers of sterile syringes could opt to use the symbol for “do not reuse” on a syringe package without adding the actual words “do not reuse” to the package. More information CDER Drug Safety Priorities Report: Initiatives and Innovation 2015-2016 This report describes critical programs that help ensure the safety of drug products, as well as key safety milestones achieved over 2015 and to date in 2016. With millions of Americans taking more medicines than at any time in history, an unanticipated drug safety problem can rapidly escalate to become a major public health threat, requiring multifaceted safety efforts across a range of scientific skills and assets. In the face of such challenges, CDER’s scientific and administrative teamwork enables rapid and balanced regulatory and public health decision making. In communicating CDER’s commitment to drug safety oversight, this report goes beyond previously issued safety-related reports to offer a broader picture, notably highlighting critical advantages gained through a range of multidisciplinary collaborations and partnerships. More information precisionFDA’s Next Challenge? Conduct an App-a-Thon! FDA is increasingly harnessing the power of supercomputers, the creative and collaborative culture of the scientific community, and novel approaches to technology to help achieve advances in diagnostics, therapeutics, and analytics that will ultimately benefit patients. More information FDA Requesting Additional Nominations for Patient Representatives on its First Patient Engagement Advisory Committee The FDA is requesting additional nominations for patient representatives to serve as voting members on its Patient Engagement Advisory Committee (PEAC). This committee will consist of patients and their care-partners (active partner or advocate in a patient’s care and health care decisions). PEAC members will serve as a resource to the FDA in patient experience, needs, and the activities of a patient community. PEAC members also advise the Commissioner and the Agency on ways to incorporate the patient perspective on FDA decisions that may affect them. The FDA is seeking diverse nominees to include members of multiple racial, ethnic and gender groups, individuals with and without disabilities, and encourages nominations of appropriately qualified candidates from these groups. More information OPPORTUNITIES FOR COMMENT / GUIDANCES Product-Specific Recommendations for Generic Drug Development FDA has published 67 product-specific recommendations (34 new and 33 revised) describing the Agency’s current thinking and expectations on how to develop generic drug products that are therapeutically equivalent to specific reference-listed drugs. FDA always seeks feedback and considers all comments to the docket before it begins work on the final versions of BE guidances. More information Guidance for Industry: Use of the Term “Healthy” in the Labeling of Human Food Products The purpose of this guidance is to advise manufacturers who wish to use the implied nutrient content claim “healthy” to label their food products as provided by our regulations. More information Draft Guidance - Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods FDA has extended the comment periods for the Draft Guidance entitled, “Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods” that appeared in the Federal Register of June 2, 2016. In the notice, we requested comments on developing the sodium targets and for implementation of the guidance document. We are taking this action in response to requests to extend the two comment periods to allow interested persons additional time to submit comments. More information PRODUCT APPROVALS & CLEARANCES FDA approves first automated insulin delivery device for type 1 diabetes FDA approved Medtronic’s MiniMed 670G hybrid closed looped system, the first FDA-approved device that is intended to automatically monitor glucose (sugar) and provide appropriate basal insulin doses in people 14 years of age and older with type 1 diabetes. More information FDA approves Amjevita, a biosimilar to Humira FDA approved Amjevita (adalimumab-atto) as a biosimilar to Humira (adalimumab) for multiple inflammatory diseases. The FDA’s approval of Amjevita is based on review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Amjevita is biosimilar to Humira. More information FDA approves expanded indications for Ilaris for three rare diseases FDA approved three new indications for Ilaris (canakinumab). The new indications are for rare and serious auto-inflammatory diseases in adult and pediatric patients: Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS); Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD); and Familial Mediterranean Fever (FMF). All three syndromes are hereditary diseases that are characterized by periodic attacks of fever and inflammation, as well as severe muscle pain. There are no previously approved therapies for TRAPS or HIDS/MKD.  More information For more information on drug approvals or to view prescribing information and patient information, please visit Drugs at FDA orDailyMed PRODUCT SAFETY Direct-Acting Antivirals for Hepatitis C: Drug Safety Communication - Risk of Hepatitis B Reactivating The FDA is warning about the risk of hepatitis B virus (HBV) becoming an active infection again in any patient who has a current or previous infection with HBV and is treated with certain direct-acting antiviral (DAA) medicines for hepatitis C virus. In a few cases, HBV reactivation in patients treated with DAA medicines resulted in serious liver problems or death. HBV reactivation usually occurred within 4-8 weeks. More information Homeopathic Teething Tablets and Gels: FDA Warning - Risk to Infants and Children The FDA is warning consumers that homeopathic teething tablets and gels may pose a risk to infants and children. The FDA is analyzing adverse events reported to the agency regarding homeopathic teething tablets and gels, including seizures in infants and children who were given these products, since a 2010 safety alert about homeopathic teething tablets. The FDA is currently investigating this issue, including testing product samples. More information Sterile Products by Wells Pharmacy Network: Recall - Concern for Lack of Sterility Assurance Wells Pharmacy Network is voluntarily recalling all sterile human and veterinary products prepared between February 22, 2016 and September 14, 2016, and that remain within expiry due to FDA concern over a lack of sterility assurance.  More information Small Battery Drive and Small Battery Drive II Adaptor and Light Adaptor by DePuy Synthes: Class I Recall - Possible Explosion Risk DePuy Synthes is recalling the Adaptor and Light Adaptor for their SBD and SBD II due to a potential for the adaptors to produce extreme internal pressure, which may cause the device to explode. The use of affected products may cause serious adverse health consequences, including death.  More information 50mm 0.2 Micron Filters by Baxter: Recall - Potential for Missing Filter Support Membrane, Particulate Matter Baxter International Inc. announced today it is voluntarily recalling all unexpired lots of 50mm 0.2 micron filters (product code H93835, expiration 6/27/2016 – 6/27/2019) due to the potential for a missing filter support membrane and for potential presence of particulate matter. These issues are associated with a component manufactured by an external supplier, and were identified prior to patient involvement as a result of complaints from customers at compounding facilities. More information Need Safety Information? For more important safety information on human drugs, medical devices, dietary supplements and more, or to report a problem with a medical product, please visit MedWatch. To receive MedWatch Safety Alerts by emailsubscribe here. 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. Other types of meetings listed may require prior registration and fees.  Click on "more information" for details about each meeting.  Please visit FDA’s Advisory Committee webpage for more information. Please visit Meetings, Conferences, & Workshops for more information on other agency meetings. DDI Webinar Series: FDA’s Bad Ad Program and other Innovative FDA Collaborations (Oct 6) FDA’s Division of Drug Information in the Center for Drug Evaluation and Research (CDER) is presenting a series of continuing education webinars targeting the needs of all healthcare professionals and future clinicians. More information Vaccines and Related Biological Products Advisory Committee Meeting (Oct 13) The committee will meet in open session to discuss and make recommendations on the selection of strains to be included in an influenza virus vaccine for the 2017 southern hemisphere influenza season. Committee members will participate via teleconference. More information Bone, Reproductive, and Urologic Drugs Advisory Committee Meeting (Oct 19) The committee will discuss the efficacy and safety of new drug application (NDA) 201656 (desmopressin), 0.75 mcg/0.1 mL and 1.5 mcg/0.1 mL nasal spray, submitted by Serenity Pharmaceuticals, LLC, for the proposed treatment of adult onset nocturia. More information Biosimilar User Fee Act Public Meeting (Oct 20) The purpose of the meeting is to hear the public's views on the proposed recommendations for the reauthorization of BsUFA II. The following information is provided to help potential meeting participants better understand the history and evolution of the BsUFA program and the proposed BsUFA II recommendations. More information Allergenic Products Advisory Committee Meeting (Oct 27) The committee will hear updates of research programs in the Laboratory of Immunobiochemistry of the Division of Bacterial, Parasitic and Allergenic Products (DBPAP), Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. More information Public Workshop - Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers (Oct 27-28) The topics to be discussed are the current regulatory environment for these activities, the definitions of the various terms FDA proposed in our prior Federal Register notice on this subject, and whether these activities should appropriately be regulated by FDA or a non-governmental organization.  More information General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products Public Meeting (Oct 31 - Nov 1) In the notice of availability for the draft guidance General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products (81 FR 16186, 16187), FDA announced its intent to hold a public meeting to discuss further the evaluation of abuse deterrence of generic opioid drug products and related issues, as appropriate. FDA will be holding this public meeting on October 31 and November 1, 2016 near the FDA campus in Silver Spring, MD.  More information National Center for Toxicological Research Science Advisory Board Meeting (Nov 1-2) On November 1, 2016, the SAB Chair will welcome the participants, and the NCTR Director will provide a Center-wide update on scientific initiatives and accomplishments during the past year. The SAB will be presented with an overview of the Division of Bioinformatics and Biostatistics Subcommittee and the Subcommittee Site Visit Report and a response to this review.  On November 2, 2016, the Center for Biologics and Evaluation and Research, Center for Drug Evaluation and Research, Center for Devices and Radiological Health, Office of Food and Veterinary Medicine, Center for Tobacco Products, and the Center for Veterinary Medicine will each briefly discuss their center-specific research strategic needs and potential areas of collaboration. More information Antimicrobial Drugs Advisory Committee Meeting (Nov 4) The committee will discuss new drug applications 209006 and 209007, solithromycin capsules and solithromycin for injection, sponsored by Cempra Pharmaceuticals, Inc., respectively for the proposed indication of treatment of community-acquired bacterial pneumonia (CABP). More information Risk Communication Advisory Committee Meeting (Nov 7) The committee will discuss and make recommendations on FDA's draft Strategic Plan for Risk Communication and Health Literacy. The purpose of the Strategic Plan for Risk Communication and Health Literacy is to clarify how the Agency can communicate the benefits and risks of FDA-regulated products to target audiences more effectively, and so promote better informed decision making. The committee will also hear presentations on some of FDA's external communications and how these communications relate to the draft Strategic Plan for Risk Communication and Health Literacy. More information Microbiology Devices Panel of the Medical Devices Advisory Committee Meeting (Nov 9-10) On November 9, the committee will discuss and make recommendations regarding the reclassification of quantitative Cytomegalovirus (CMV) viral load devices from class III (Premarket approval) to class II (510(k)). On November 10, the committee will discuss and make recommendations to FDA regarding how FDA might handle a future premarket notification (510(k)) submission for a Procalcitonin (PCT) test. More information Blood Products Advisory Committee Meeting (Nov 17-18) On the morning of November 17, 2016, the Committee will meet in open session to discuss strategies to manage iron deficiency associated with blood donation. The Committee will also discuss proposed procedures for assuring donor safety for collections of blood from female donors with hemoglobin values of 12.0-12.4g/dL or a hematocrit value between 36 and 38. In the afternoon, the Committee will meet in open session to discuss adverse reactions related to blood donation in teenage (16 to 18 years) donors, and the effectiveness of several mitigation measures. On November 18, 2016, the Committee will meet in open session to hear an informational session on Zika virus and blood safety in the United States. Following the informational session, the Committee will hear presentations on the following topics: (1) The Transfusion Transmissible Infections Monitoring System; (2) a summary of the FDA workshop on new methods to predict the immunogenicity of therapeutic coagulation proteins; and (3) a summary of the FDA workshop on preclinical evaluation of red blood cells for transfusion.More information RESOURCES For more important safety information on human drug and devices or to report a problem to FDA, please visit MedWatch Comunicaciones de la FDA sobre la seguridad de los medicamentos en español Descargo de responsabilidad: La FDA reconoce la necesidad de proporcionar información sobre seguridad importante en idiomas distintos al inglés. Hacemos lo mejor posible  para proporcionar  versiones en español precisas y oportunas de nuestras Comunicaciones de Seguridad de Medicamentos. Sin embargo, en caso que existiera discrepancias entre las versiones en ingles y en español, la información contenida en la versión en inglés es la que se considera como versión oficial. Si tiene alguna pregunta, por favor contáctese con Division of Drug Information endruginfo@fda.hhs.gov. Comunicaciones de la FDA MedWatchLearn - Practice Reporting to FDA! This web-based learning tool teaches students, health professionals, and consumers how to complete the forms necessary to report problems to FDA.More information  FDA Expert Commentary and Interview Series on Medscape As part of the continuing collaboration between FDA and Medscape, a series of interviews and commentaries are available to communicate important safety information to clinicians. Featuring FDA experts, these original commentaries cover a wide range of topics related to FDA's multi-faceted mission of protecting and promoting the public health by ensuring the safety and quality of medical products such as drugs, foods, and medical devices More information Cardiovascular and Endocrine Liaison Program The Cardiovascular and Endocrine Liaison Program serves as a liaison between the FDA and the cardiovascular and endocrine health professional and patient communities. Discover how you or your organization can collaborate with FDA. More information Medical Product Safety Network (Medsun) Medsun improves FDA's understanding of problems with the use of medical devices so that the FDA, healthcare facilities, clinicians, and manufacturers can better address safety concerns.  The Medsun newsletter provides monthly updates about timely medical device issues that may impact patient safety.  More information 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. More information FDA Voice FDA voice is the official blog from FDA's senior leadership and staff.More information