FDA Patient Network Newsletter - August 30, 2017

This bi-weekly newsletter from the Food and Drug Administration (FDA) Office of Health and Constituent Affair is intended to inform patients and patient advocates of FDA-related information on new product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings, proposed regulatory guidances and opportunity to comment, and other information of interest. Subscribe or update your subscriber preferences. Statement from FDA Commissioner Scott Gottlieb, M.D. on the FDA's new policy steps and enforcement efforts to ensure proper oversight of stem cell therapies and regenerative medicine One of the most promising new fields of science and medicine is the area of cell therapies and their use in regenerative medicine. These new technologies, most of which are in early stages of development, hold significant promise for transformative and potentially curative treatments for some of humanity's most troubling and intractable maladies. Recent advances in our basic knowledge of the pathways involved in tissue damage and regeneration have combined with remarkable progress in adult stem cell biology to put us at a genuine inflection point in the history of medicine. The prospect of clinical tissue repair strategies is a tangible reality. This promise is reinforced by the strong commitment of the investment and scientific communities in exploring the potential applications across a wide range of vexing diseases and conditions, such as cancer, Parkinson's disease, and diabetes, among many others. However, with all of the medical potential, also comes novelty and uncertainty as this field matures. There are a small number of unscrupulous actors who have seized on the clinical promise of regenerative medicine, while exploiting the uncertainty, in order to make deceptive, and sometimes corrupt, assurances to patients based on unproven and, in some cases, dangerously dubious products. These dishonest actors exploit the sincere reports of the significant clinical potential of properly developed products as a way of deceiving patients and preying on the optimism of patients facing bad illnesses. This puts the entire field at risk. Products that are reliably and carefully developed will be harder to advance if bad actors are able to make hollow claims and market unsafe science. In such an environment a select few, often motivated by greed without regard to responsible patient care, are able to promote unproven, clearly illegal, and often expensive treatments that offer little hope, and, even worse, may pose significant risks to the health and safety of vulnerable patients. These so-called treatments run afoul of the FDA's legal and regulatory framework governing this new field. Full statement and more information Recall: Ninjacof and Ninjacof A - Potential Burkholderia Cepacia Contamination Centurion Labs is voluntarily recalling, as a precautionary measure, 1 lot of Ninjacof (Lot# 200N1601) and 1 lot of Ninjacof A (Lot# 201NA1601) manufactured by Vilvet (Dania Beach, FL) and distributed by Centurion Labs to the retail level due to potential contamination with Burkholderia cepacia. Centurion was notified by the FDA regarding the potential contamination as they discovered this product may have been manufactured in a Pharmatech, FDA registered facility, in Davie, FL. that was found to have a product that contained B. cepacia. Use of a product that may contain B. cepacia, could result in infections in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis. Some of these infections may be serious or even life threatening in the at-risk patient population. More information Comunicaciones de la FDA sobre la seguridad de los medicamentos en español Descargo de responsabilidad: La FDA reconoce la necesidad de proporcionar información importante sobre seguridad de los medicamentos 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 inglés y la de 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 FDA knows the major public health consequences that can result from drug shortages. These shortages occur for many reasons including manufacturing and quality problems, delays and discontinuations. When issues are discovered, FDA works closely with the company to address risks involved to prevent harm to patients. FDA also considers the impact a shortage would have on patient care and access and works with the company to restore supplies while also ensuring safety for patients. More information Drug Shortages Voluntarily Reported by Manufacturers During the Past 2 Weeks: Sodium Phosphate Injection Drug Discontinuation Voluntarily Reported by Manufacturers During the Past 2 Weeks: Barium Sulfate (E-Z-CAT DRY) for Oral Suspension Barium Sulfate (E-Z-CAT DRY) Powder for Suspension Buspirone HCl Tablets Cholofrafin Meglumine (Iodipamide Meglumine) Injection Epirubicin Hydrochloride Injection (Impax Laboratories) Glyburide Tablets Glyburide Metformin Tablets Iodixanol (Visipaque) Injection Midodrine HCl Tablets Nadolol and Bendroflumethiazide Tablets Information about blood and biologic shortages, resolved shortages, and discontinuations La FDA reconoce las consecuencias significativas para la salud pública que pueden resultar de la escasez de medicamentos y hace un gran esfuerzo dentro de sus facultades  legales para abordar y prevenir la escasez de medicamentos. La escasez se produce por muchas razones, incluyendo problemas de fabricación y calidad, retrasos y discontinuación del producto. Cuando los problemas son descubiertos por la empresa o el público y reportados a la FDA o se descubren por inspecciones de la FDA, la FDA trabaja en estrecha colaboración con la empresa para hacer frente a los riesgos involucrados y evitar daños a los pacientes. La FDA también considera el impacto que una escasez tendría en la atención médica del paciente y al acceso del producto y trabaja con la empresa para restablecer el suministro al tiempo que garantiza la seguridad de los pacientes. Más información FDA approval brings first gene therapy to the United States FDA has issued a historic action today making the first gene therapy available in the United States, ushering in a new approach to the treatment of cancer and other serious and life-threatening diseases. The FDA approved Kymriah (tisagenlecleucel) for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL). "We're entering a new frontier in medical innovation with the ability to reprogram a patient's own cells to attack a deadly cancer," said FDA Commissioner Scott Gottlieb, M.D. "New technologies such as gene and cell therapies hold out the potential to transform medicine and create an inflection point in our ability to treat and even cure many intractable illnesses. At the FDA, we're committed to helping expedite the development and review of groundbreaking treatments that have the potential to be life-saving." Kymriah (tisagenlecleucel), a cell-based gene therapy, is approved in the United States for the treatment of patients up to 25 years of age with B-cell precursor ALL that is refractory or in second or later relapse. Kymriah is a genetically-modified autologous T-cell immunotherapy. Each dose of Kymriah is a customized treatment created using an individual patient's own T-cells, a type of white blood cell known as a lymphocyte. The patient's T-cells are collected and sent to a manufacturing center where they are genetically modified to include a new gene that contains a specific protein (a chimeric antigen receptor or CAR) that directs the T-cells to target and kill leukemia cells that have a specific antigen (CD19) on the surface. Once the cells are modified, they are infused back into the patient to kill the cancer cells. More information FDA approves inotuzumab ozogamicin for relapsed or refractory B-cell precursor ALL FDA has approved inotuzumab ozogamicin (BESPONSA, Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).The approval was based on data from INO-VATE ALL (NCT01564784), a randomized (1:1), open label, international, multicenter study in 326 patients with Philadelphia chromosome-negative or Philadelphia chromosome-positive relapsed or refractory B-cell precursor ALL. Patients were required to have ≥5% bone marrow blasts and to have received one or two previous induction chemotherapy regimens for ALL. Patients with Philadelphia chromosome positive B cell precursor ALL were required to have disease that failed treatment with at least one tyrosine kinase inhibitor and standard chemotherapy. More information FDA approves olaparib tablets for maintenance treatment in ovarian cancer FDA has granted regular approval to olaparib tablets (Lynparza, AstraZeneca) for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy. With the addition of the new indication, a tablet formulation of olaparib is introduced. FDA approved olaparib capsules in 2014 for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. FDA also approved olaparib tablets for this indication. Olaparib tablets and capsules are not interchangeable. Olaparib capsules are being phased out of the U.S. market and will be available only through the Lynparza Specialty Pharmacy Network. More information FDA approves new treatment for adults with relapsed or refractory acute lymphoblastic leukemia FDA has approved Besponsa (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). "For adult patients with B-cell ALL whose cancer has not responded to initial treatment or has returned after treatment, life expectancy is typically low," said Richard Pazdur, M.D., director of the FDA's Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. "These patients have few treatments available and today's approval provides a new, targeted treatment option." B-cell precursor ALL is a rapidly progressing type of cancer in which the bone marrow makes too many B-cell lymphocytes, an immature type of white blood cell. The National Cancer Institute estimates that approximately 5,970 people in the United States will be diagnosed with ALL this year and approximately 1,440 will die from the disease. More information FDA provides new tools for the development and proper evaluation of tests for detecting Zika virus infection As an additional measure in the fight against Zika virus, FDA has announced that it has made available a panel of human plasma samples to aid in the regulatory evaluation of serological tests to detect recent Zika virus infection. "At the onset of the Zika virus outbreak, when little was known about the disease or how to diagnose it, the FDA worked quickly with manufacturers to encourage the development of diagnostic tests and ensure they were available using its Emergency Use Authorization authorities," said FDA Commissioner Scott Gottlieb, M.D. "By providing manufacturers of these tests with standardized patient samples to use in properly validating these diagnostics, we will be able to better assess how well their tests perform. This is part of our effort to ultimately bring these tests through the FDA's formal review process to better ensure their reliability, and to enable broader access to Zika diagnostic testing." More information FDA approves first U.S. treatment for Chagas disease FDA has granted accelerated approval to benznidazole for use in children ages 2 to 12 years old with Chagas disease. It is the first treatment approved in the United States for the treatment of Chagas disease. Chagas disease, or American trypanosomiasis, is a parasitic infection caused by Trypanosoma cruzi and can be transmitted through different routes, including contact with the feces of a certain insect, blood transfusions, or from a mother to her child during pregnancy. After years of infection, the disease can cause serious heart illness, and it also can affect swallowing and digestion. While Chagas disease primarily affects people living in rural parts of Latin America, recent estimates are that there may be approximately 300,000 persons in the United States with Chagas disease. More information FDA approves new antibacterial drug FDA has approved Vabomere for adults with complicated urinary tract infections (cUTI), including a type of kidney infection, pyelonephritis, caused by specific bacteria. Vabomere is a drug containing meropenem, an antibacterial, and vaborbactam, which inhibits certain types of resistance mechanisms used by bacteria. "The FDA is committed to making new safe and effective antibacterial drugs available," said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research. "This approval provides an additional treatment option for patients with cUTI, a type of serious bacterial infection." More information For information on drug approvals or to view prescribing information and patient information, please visit Drugs@FDA or DailyMed.   View FDA's Comments on Current Draft Guidance page, for a list of current draft guidances and other topics of interest for patients and caregivers. Opportunities to Comment - September Opportunities to Comment - October Opportunities to Comment - November Working to Improve Information on Medication Use during Pregnancy, by Pamela Scott, Ph.D., Deputy Director and Director of Research and Development, FDA Office of Women's Health When women are pregnant they take care to eat right and refrain from smoking and drinking alcoholic beverages. But what to do about prescription drugs is a more complicated topic. There are very few prescription medications that have been specifically approved for use during pregnancy. And yet, doctors in clinical practice must prescribe needed medicines to pregnant women to treat a variety of illnesses and conditions such as diabetes, high blood pressure or even something as simple as a dental infection. Indeed, about half of the 6.3 million women who are pregnant every year take at least one medication, and prescription use is on the rise, up by more than 60 percent from 1976 through 2008. More information is clearly needed. To read the rest of this post, see FDA Voice, August 21, 2017. FDARA: Making a Difference for Industry and Patients, by Peter Marks, M.D., Ph.D., Director of FDA's Center for Biologics Evaluation and Research; Jeffrey Shuren, M.D., J.D., Director of FDA's Center for Devices and Radiological Health; and Janet Woodcock, M.D., Director of FDA's Center for Drug Evaluation and Research For decades, user fees paid by the medical products industry have provided critical resources needed to conduct product reviews in a timely fashion and to help ensure the safety and effectiveness of medical products that American patients depend upon. Since passage of the first medical product user fee act in 1992, the user fee laws and corresponding performance goals and program enhancements have helped evolve the drug and device review process in the United States allowing patients access to new and innovative treatments as quickly as possible without compromising the Agency's high standards. As directors of FDA's three medical product centers, we want to applaud the U.S. Congress for passing the FDA Reauthorization Act of 2017 (FDARA), which President Trump signed into law on Friday. To read the rest of this post, see FDA Voice, August, 21, 2017. Food and Water Safety During Power Outages and Floods Emergencies can happen, especially with extreme weather conditions. When they do, the best strategy is to already have a plan in place. This includes knowing the proper food safety precautions to take before, during, and after a power outage — and being prepared to safely handle food and water in the event that flooding occurs. See Safety During Floods and Prepare Yourself Before Power Emergencies. In this section you will find a comprehensive list of all the meetings that the FDA is involved with. The meetings may include advisory committee meetings, public workshops and public conferences that are seeking to hear from patients and caregivers. Most FDA meetings are free to the public and do not require the public to register.  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. Calendar of FDA Sponsored Public Meetings - September Calendar of FDA Sponsored Public Meetings - October  View FDA's Patient Network Calendar of Public Meetings page for a complete list of meetings and workshops. For additional information on other agency meetings please visit Meetings, Conferences, & Workshops. Healthy Breakfasts for Kids: It's All About Balance A healthy breakfast is a must for kids.Skip it and your kids will be playing nutritional catch-up for the rest of the day, says Carole L. Adler, M.A., R.D., a dietitian at the Food and Drug Administration (FDA). When kids skip breakfast, they don't get what they need to be at their best, says Adler. "Growing bodies and developing brains need regular, healthy meals," she says. According to the Academy of Nutrition and Dietetics, studies show that school children who eat breakfast perform better in the classroom. See "Seven Breakfast Tips" and Video More Consumer Updates For previously published Consumer Update articles that are timely and easy-to-read and cover all FDA activities and regulated products. More information En Español La información en esta página es para el público en general, y para profesionales y educadores de salud. Esta información puede ser distribuida y publicada sin previa autorización. En Español Building a Customized Plan to Help Ensure Food Safety Every day we evaluate potential hazards in our lives, and take steps to avoid them. We wear our seatbelts. We baby-proof our homes when we have young children. We use passwords to protect secure information online. You might say that when we know hazards exist we put preventive controls in place to protect ourselves. Preventive controls – steps taken to reduce or eliminate risk – also are at the heart of the rules mandated by the FDA Food Safety Modernization Act (FSMA). They ask the food industry to approach potential hazards in much the same way that we do in our personal life: identify them and take action to prevent them from harming us. In September 2015, FDA finalized the Preventive Controls for Human Food rule, which requires owners and operators of food facilities to develop a food safety plan that identifies hazards and puts preventive controls in place to minimize or prevent those hazards. But where should owners and operators start? If they haven't had issues in their facilities before, what should they be looking for? How do they compile their information about hazards and controls in a systematic way? Answers and more The Safety Reporting Portal The Safety Reporting Portal (SRP) streamlines the process of reporting product issues to the Food and Drug Administration and the National Institutes of Health. Whatever your role, (manufacturer, health care professional, researcher, public health official, or concerned citizen), when you submit a safety report through this Portal, you make a vital contribution to the safety of America's food supply, medicines, and other products that touch us all. More information Center for Food Safety and Applied Nutrition The Center for Food Safety and Applied Nutrition, known as CFSAN, carries out the mission of FDA. The Center provides services to consumers, domestic and foreign industry and other outside groups regarding field programs; agency administrative tasks; scientific analysis and support; and policy, planning and handling of critical issues related to food and cosmetics. More information Food Facts for You The Center for Food Safety and Applied Nutrition, known as CFSAN, issues food facts for consumers to keep you and your family safe. More information Ticks and Lyme Disease: Symptoms, Treatment, and Prevention Tick-borne diseases such as Lyme disease are on the rise. Cases in the United States increased from about 12,000 annually in 1995 to nearly 40,000 in 2015, according to the Centers for Disease Control and Prevention (CDC). Experts believe the real number of infections is likely closer to 300,000. FDA regulates products that are used to help diagnose and treat this complex disease in humans. There are no licensed vaccines in the United States to aid in the prevention of Lyme disease in people. More information Animal Health Literacy Animal Health Literacy means timely information for the benefit of all animals and their humans. With continuous communication and outreach, the Center for Veterinary Medicine (CVM) strives to enhance the public trust, promote safe and effective use of the animal health products we regulate, and share our scientific endeavors. CVM provides reliable, science-based information to promote animal and human health. More information and Publicaciones en Español del FDA  Animal and Veterinary Updates Animal and veterinary updates provide information to keep your pets healthy and safe. More information How to Report a Pet Food Complaint You can report complaints about a pet food product electronically through the Safety Reporting Portal or you can call your state's FDA Consumer Complaint Coordinators. Please provide as much information as possible in your complaint, such as exact name of product, type of container, lot number, UPC codes, how the food was stored, and purchase date and exact location where purchased. If possible, please save the original packaging until the pet food has been consumed. The packaging contains IMPORTANT information often needed to identify the variety of pet food, the manufacturing plant, and the production date. More information FDA releases age calculator app for tobacco retailers Takings steps to protect youth from the harms of tobacco, the FDA recently released a voluntary smartphone application, "FDA Age Calculator," on the Google Play and iTunes app stores designed to help tobacco retailers comply with age restriction laws. Retailers will now be able to use their personal smartphones to help determine if a purchaser is old enough under federal law to buy tobacco products. Find out more about FDA's efforts to prevent tobacco use among youth. FDA to expand public education campaign to address youth e-cigarette use The FDA announced plans to expand its "The Real Cost" public education campaign to include messaging to teens about the dangers of using e-cigarettes and other electronic nicotine devices (ENDS) this fall, while developing a full-scale campaign to launch in 2018. This effort is a part of the agency's new comprehensive plan for tobacco and nicotine regulation, as well as ongoing efforts to educate youth about, and protect them from, the dangers associated with using all tobacco products. It is the first time the FDA will be utilizing public health education to specifically target youth use of e-cigarettes or other ENDS. Comments invited as FDA reviews "modified risk" tobacco product applications The public can now comment on modified risk tobacco product (MRTP) applications submitted by Philip Morris Products S.A., for its IQOS system and three types of Marlboro Heatstick products. By law, tobacco products may not be marketed as being less harmful or presenting lower risk of tobacco-related disease without a written order from FDA, and there are no authorized MRTPs currently on the market in the United States. You can view related Philip Morris Products S.A. documents as they become publicly available, and comment through Dec. 12. Missed the last issue of CTPConnect? The Center also publishes a regular periodical known as CTPConnect, a plainspoken digest with the latest stories from the Center. Sign up today to receive the next issue of CTPConnect and other important updates from CTP directly to your inbox. Bad reaction to a cosmetic? FDA needs to know What do you do if you have a reaction after using a cosmetic product? First, stop using the product and contact your healthcare provider. Next, please report it to FDA. Here's why that next step is so important: Cosmetic products aren't required by law to have FDA approval before they go on the market. Companies that market cosmetics have a legal responsibility to ensure product safety, but FDA can only take action if the product is shown to be unsafe after the product is on the market. And, because the law doesn't require cosmetic companies to share customer complaints or other safety information with FDA, voluntary reports from consumers and healthcare providers are one of the best ways for FDA to learn about any problems. Cosmetics include a range of products people use every day, such as moisturizers, makeup, shampoos and conditioners, face and body washes, deodorants, nail care products, hair dyes and relaxers, and tattoos. More information Recalls and Alerts To see safety alerts and  recent recalls related to cosmetics and other products regulated by FDA. More information What to watch for, how to report You can report an allergic reaction, a rash, redness, burn, hair loss, headache, infection, illness, or any other unexpected reaction, whether or not it required medical treatment. You can also report a bad smell, color change, or other sign of contamination. You can choose the way you'd prefer to report: Call an FDA Consumer Complaint Coordinator if you want to speak directly to a person about your problem. Complete an electronic Voluntary MedWatch form online. Complete a paper Voluntary MedWatch form that you can mail to FDA. More information Information about Expanded Access Expanded access, sometimes called "compassionate use," is the use outside of a clinical trial of an investigational medical product (i.e., one that has not been approved by FDA). FDA is committed to increasing awareness of and knowledge about its expanded access programs and the procedures for obtaining access to human investigational drugs (including biologics) and medical devices. More information Learn about what your physician should do before submitting a request for individual patient expanded access use of an investigational medical product, who may be eligible for expanded access, associated costs, FDA contacts and more. Information for Patients Learn about your responsibilities under the expanded access pathway, how to submit a request for expanded access for an individual patient (including for emergency use), which forms to use, FDA contacts and more. Information for Physicians FDA Patient Network The FDA Patient Network contains a series of webpages, webinars and presentations on topics related to patient engagement, FDA regulations, understanding medical product (Drugs, Biologics, and Devices) approval and medical product safety updates, Take me to the FDA Patient Network , Follow us on twitter or take me to FDA Webinars. 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 Educational Videos FDA Food Safety and Modernization Act: An FDA Primer The Rulemaking Process: An FDA Primer What is Regulatory Science Taking Acetaminophen Safely healthfinder.gov Welcome to healthfinder.gov, a government Web site where you will find information and tools to help you and those you care about stay healthy. More information /más información FDA Email Updates Sign up for one of the FDA disease specific e-mail list that delivers updates, including product approvals, safety warnings, notices of upcoming meetings, and notices on proposed regulatory guidances. Diabetes Cardiovascular Disease HIV Hepatitis B and C You may wish to sign up for other email updates from the FDA - see other email updates. Subscriber Services: Manage Preferences  |  Unsubscribe  |  Help with this service Stay Connected: This email was sent to bsamad2007.adnan@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 1-888-INFO-FDA (1-888-463-6332)