FDA Updates For Health Professionals

May 31, 2017 UPDATES FOR HEALTH PROFESSIONALS Office of Health and Constituent Affairs ANNOUNCEMENTS OPPORTUNITIES FOR COMMENT / GUIDANCES PRODUCT APPROVALS & CLEARANCES PRODUCT SAFETY UPCOMING MEETINGS RESOURCES ANNOUNCEMENTS A Year Later, FDA Is Better and Stronger in Protecting Consumers from Unsafe Foods Almost a year ago, we heard concerns that FDA was not doing enough to ensure that companies promptly and effectively initiate recalls of potentially dangerous food products in those rare instances in which a firm is not responding appropriately. FDA has always been committed to protecting the U.S. food supply, which is among the safest in the world, but we recognized the need to strengthen certain compliance and enforcement strategies in cases made more complex by factors that include the nature of the product, the scope of available evidence, and the company's response. At the heart of this change was the creation of SCORE, which stands for Strategic Coordinated Oversight of Recall Execution. More information FDA Video History Series: Radiating Shoe Sales Since the discovery of X-rays in the late 19th century, the technology has enhanced health care in a variety of ways. Like many cutting-edge scientific developments, however, it also has inspired uses of uncertain therapeutic value. That was the case with the shoe-fitting fluoroscope, the subject of the latest episode of FDA's history video series. Marketed as a scientific method for optimizing shoe fit, the fluoroscope appeared in shoe stores nationwide from the 1920s to the 1960s. But the machines not only didn't do what they promised, they also exposed children, their parents, and store clerks to unhealthy doses of radiation. More information FDA Commissioner Asks Staff for 'More Forceful Steps' to Stem the Opioid Crisis As Commissioner, my highest initial priority is to take immediate steps to reduce the scope of the epidemic of opioid addiction. I believe the FDA continues to have an important role to play in addressing this crisis, particularly when it comes to reducing the number of new cases of addiction. I believe it is within the scope of FDA's regulatory tools – and our societal obligations – to take whatever steps we can, under our existing legal authorities, to ensure that exposure to opioids is occurring under only appropriate clinical circumstances, and for appropriate patients. More information Modernizing the Way Drugs Are Made: A Transition to Continuous Manufacturing For more than 50 years, pharmaceuticals have been produced using a method known as "batch manufacturing," a multi-step, lengthy process that involves the use of ungainly, large-scale equipment. However, recent advances in manufacturing technology have prompted the pharmaceutical industry to consider moving away from batch manufacturing to a faster, more efficient process known as continuous manufacturing. The FDA is taking proactive steps to facilitate the drug industry's implementation of emerging technologies, including continuous manufacturing, to improve product quality and address many of the underlying causes of drug shortages and recalls. 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. In this recent interview, Gerald Dal Pan, MD, MHS, Director, Office of Surveillance and Epidemiology at CDER discusses two recent studies which have raised potential concerns about the safety of newly approved drugs; FDA's safety monitoring process; and what are changes needed. More information Drug Information Soundcast in Clinical Oncology (D.I.S.C.O.) FDA Drug Information Soundcast in Clinical Oncology (DISCO) is a new FDA podcast series that provides information about new product approvals, emerging safety information for cancer treatments, and other current topics in cancer drug development. The series features five podcasts, as well as transcripts. More information FSMA Collaborative Training Forum: 'Educate Before and While We Regulate' "We will educate before and while we regulate" has been a mantra for FDA as the rules that implement the FDA Food Safety Modernization Act (FSMA) have taken shape. Making sure that food producers understand the new requirements and have the knowledge they need to meet them is key to the success of this effort to prevent illnesses caused by domestic and imported foods. However, FDA recognized early on that one size won't fit all when it comes to training and that a variety of training options and delivery formats would be necessary to meet needs shaped by product, region, size, and other factors.  More information OPPORTUNITIES FOR COMMENT / GUIDANCES Request for comment by July 10, 2017: FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioids FDA is announcing the availability of draft revisions to the "FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics" (Blueprint). The Blueprint is part of the FDA-approved risk evaluation and mitigation strategy (REMS) for extended release (ER) and long-acting (LA) opioid analgesic medications (ER/LA Opioid Analgesics REMS). FDA is seeking comment on the draft revisions to the Blueprint and has added sections of draft revised Blueprint to the background materials for the public workshop that was held on May 9-10, 2017. Although the draft revisions to the Blueprint will not be a discussion topic at the workshop, FDA expects the draft revisions to provide important context for discussions during the workshop. More information Request for comment by July 10, 2017: Training for Opioid Analgesic Prescribers - Exploring the Path Forward As part of the work by the Federal Government to address the epidemic of prescription and illicit opioid abuse, the FDA is announcing a public workshop to obtain input on issues and challenges associated with Federal efforts to support training on pain management and the safe prescribing, dispensing, and patient use of opioids (safe use of opioids) for health care providers. As discussed in this document, the workshop has three main goals. First, participants will be asked to discuss the role that health care provider training plays, within the broader context of ongoing activities, to improve pain management and the safe use of opioids. Second, participants will be asked to comment on how best to provide health care providers, who prescribe or are directly involved in the management or support of patients with pain, appropriate training in pain management and the safe use of opioids. Finally, participants will be asked about the issues and challenges associated with possible changes to Federal efforts to educate health care providers on pain management and the safe use of opioids. More information PRODUCT APPROVALS & CLEARANCES FDA approves first cancer treatment for any solid tumor with a specific genetic feature FDA granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker). This is the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated. Keytruda (pembrolizumab) is indicated for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors that have been identified as having a biomarker referred to as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). This indication covers patients with solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options and patients with colorectal cancer that has progressed following treatment with certain chemotherapy drugs. More information FDA approves first generic Strattera for the treatment of ADHD FDA approved the first generic versions of Strattera (atomoxetine) to treat attention-deficit/hyperactivity disorder (ADHD) in pediatric and adult patients. Apotex Inc., Teva Pharmaceuticals USA Inc., Aurobindo Pharma Limited and Glenmark Pharmaceuticals Limited today gained approval to market atomoxetine in multiple strengths. In the clinical trials for atomoxetine in children and adolescents, the most common side effects reported were upset stomach, decreased appetite, nausea or vomiting, dizziness, tiredness, and mood swings. In the clinical trials in adults, the most common side effects reported were constipation, dry mouth, nausea, decreased appetite, dizziness, sexual side effects, and problems passing urine. More information FDA approves first drug to specifically treat giant cell arteritis FDA expanded the approved use of subcutaneous Actemra (tocilizumab) to treat adults with giant cell arteritis. This new indication provides the first FDA-approved therapy, specific to this type of vasculitis. Giant cell arteritis is a form of vasculitis, a group of disorders that results in inflammation of blood vessels. This inflammation causes the arteries to narrow or become irregular, impeding adequate blood flow. In giant cell arteritis, the vessels most involved are those of the head, especially the temporal arteries (located on each side of the head). More information FDA expands approved use of Kalydeco to treat additional mutations of cystic fibrosis FDA expanded the approved use of Kalydeco (ivacaftor) for treating cystic fibrosis. The approval triples the number of rare gene mutations that the drug can now treat, expanding the indication from the treatment of 10 mutations, to 33. The agency based its decision, in part, on the results of laboratory testing, which it used in conjunction with evidence from earlier human clinical trials. The approach provides a pathway for adding additional, rare mutations of the disease, based on laboratory data. More information For more information on drug approvals or to view prescribing information and patient information, please visit Drugs at FDA or DailyMed PRODUCT SAFETY MedWatch, The FDA Safety Information and Adverse Event Reporting Program For 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 email subscribe here. Class I Recall: SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulators by Zimmer Biomet - Potential for Harmful Chemicals Zimmer Biomet is recalling the SpF PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulators due to higher than allowed levels of potential harmful chemicals, which may be toxic to tissues and organs (cytotoxicity) and that were found during the company's routine monitoring procedure. The use of an affected product may cause serious adverse health consequences, including but not limited to chronic infections, long-term hospitalization due to additional surgical procedures, paralysis, and death. More information Recall: Mibela 24 Fe Chewable Tablets by Lupin Pharmaceuticals Inc. - Out of Sequence Tablets and Missing Expiry/Lot Information Lupin Pharmaceuticals Inc. announced a recall of Mibelas 24 Fe (Norethindrone Acetate and Ethinyl Estradiol 1 mg/0.02 mg chewable and ferrous fumarate 75 mg) Tablets at the consumer level. A confirmed market complaint indicated a packaging error, where the blister was rotated 180 degrees within the wallet, reversing the weekly tablet orientation and making the lot number and expiration date no longer visible. The first four days of therapy would have had four non-hormonal placebo tablets as opposed to the active tablets. As a result of this packaging error, oral contraceptive tablets that are taken out of sequence may place the user at  risk for contraceptive failure and unintended pregnancy.  More information Recall: Brilinta (ticagrelor) 90 mg tablets, 8-count Physician Sample Bottles - Lot # JB5047 - Report of Another Medicine in One Bottle AstraZeneca is notifying physicians and consumers that it is voluntarily recalling one lot of professional (physician) sample bottles containing eight tablets of Brilinta (ticagrelor) 90mg tablets as a precautionary measure. This voluntary recall follows a report that a professional sample bottle containing eight tablets of Brilinta 90mg also contained another medicine called Zurampic (lesinurad) 200 mg tablets which is also manufactured by AstraZeneca. Unintentional dosing with Zurampic has the potential to lead to adverse renal effects including acute renal failure which is more common when Zurampic is given alone as it should be used in combination with a xanthine oxidase inhibitor. Missed doses of Brilinta increases the risk of heart attack and stroke. More information Recall: Organic Herbal Supply Supplement Products - Undeclared Drug Ingredients Organic Herbal Supply, Inc. is conducting a voluntary nationwide recall of all lots of Uproar, Cummor, Zrect, Monkey Business, Xrect, Rectalis, Tornado, Zdaily, BigNHard, Enhancerol Natural Male Enhancement capsules. FDA analysis has found the products to contain Tadalafil, a FDA-approved drug used as treatment for male Erectile Dysfunction (ED). The presence of tadalafil in these male enhancement products renders it an unapproved drug for which safety and efficacy have not been established. Organic Herbal Supply is also recalling Zrect for Women and LabidaMAX. FDA analysis has found these products contain Flibanserin, an FDA-approved prescription drug for Hypoactive Sexual Desire Disorder (HSDD) in women. More information Recall: Caverflo Natural Herbal Coffee - Presence of Undeclared Active Pharmaceutical Ingredients  Caverflo.com is voluntarily recalling all lots of Caverflo Natural Herbal Coffee, 25 grams to the consumer level. FDA laboratory analysis confirmed the presence of Sildenafil and Tadalafil which are the active ingredients in two FDA-approved prescription drugs used for the treatment of erectile dysfunction (ED). Caverflo.com has received a report of an individual death after use of the coffee. Caverflo Natural Herbal Coffee may also contain undeclared milk. 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. 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: Ongoing Role of FDA in Medication Error Prevention (Jun 6) FDA's Division of Drug Information in the Center for Drug Evaluation and Research (CDER) is excited to present a series of educational webinars targeting the needs of all health care professionals and students, including physicians, physician assistants, nurses, pharmacists, and pharmacy technicians. On June 6, 2017 at 1pm (EDT), CDER's Office of Communication, Division of Drug Information (DDI) will host a webinar titled: Ongoing Role of FDA in Medication Error Prevention. This free webinar will provide information on the Division of Medication Error Prevention and Analysis (DMEPA)'s role in preventing and addressing medication errors. Regulatory action taken to address recent medication error reports will be explored, as well as the role of pharmacists in identifying, preventing and mitigating medication errors. More information CDER Small Business and Industry Assistance Webinar - Risk Evaluation and Mitigation Strategies (REMS): A Deeper Dive (Jun 15) The Center for Drug Evaluation and Research and Small Business and Industry Assistance (CDER SBIA), invites you to our FREE webinar series. These events focus on a specific topic and provide an opportunity for small business and industry entities to learn more about the FDA and basic drug regulation. This extended webinar format, with Q&A sessions, is intended to provide a deeper look at REMS, focusing on two topics: REMS - Purpose, Process, and Challenges; and REMS in Structured Product Labeling Format: An Introduction. More information Safe Use Symposium: A Focus on Reducing Preventable Harm from Drugs in the Outpatient Setting (Jun 15) FDA's Center for Drug Evaluation and Research, Professional Affairs and Stakeholder Engagement Staff (PASES), is hosting a one day public symposium entitled "Safe Use Symposium: A Focus on Reducing Preventable Harm from Drugs in the Outpatient Setting." The purpose of this symposium is to discuss sources of preventable harm from drugs in the outpatient setting, and to stimulate the exchange of ideas among thought leaders on interventions to reduce preventable harms and how these interventions can be studied. More information Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (Jun 20) The committee will discuss a supplemental new drug application for VICTOZA (liraglutide) injection (sNDA 022341), sponsored by Novo Nordisk, for the proposed additional indication of: As an adjunct to standard treatment of cardiovascular risk factors to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and high cardiovascular risk. More information 2017 PDA/FDA Biosimilars Conference (Jun 26 -27) The 2017 PDA/FDA Biosimilars Conference will bring together industry experts and regulators to discuss the latest advancements and strategies required to successfully bring biosimilars to market. In response to the industry's need for current and reliable information on this rapidly growing area of pharmaceutical manufacturing, the Program Planning Committee has developed an agenda that brings together industry experts and regulators to review successful development strategies for biosimilars. More information RESOURCES For more important safety information on human drug and devices or to report a problem to FDA, please visit MedWatch, The FDA Safety Information and Adverse Event Reporting Program 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 en druginfo@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. 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