miércoles, 7 de marzo de 2018

FDA Updates for Health Professionals

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FDA Updates for Health Professionals


FDA activities related to the ongoing post-market review of Essure and FDA’s commitment to keep women informed - Statement from FDA Commissioner Scott Gottlieb, M.D.
Last month I had the opportunity to meet with consumers who have been affected by the medical device Essure to listen and learn about their concerns. This device is used as a method of permanent birth control. The product’s manufacturer, Bayer, estimates that more than 750,000 women worldwide have received the device implant since it was first approved by global regulatory authorities. Some of the women I spoke to went on to develop significant medical problems that they ascribe to their use of the product. As a physician, I know that patients are uniquely positioned to provide feedback to the FDA about their experiences with currently available medical products, and I appreciated the thoughtful discussion. Ensuring the safety and effectiveness of medical products is paramount to the FDA and a core part of our consumer protection role. The FDA takes concerns about Essure very seriously. I would like to outline the steps we’ve taken, to date, regarding this product, and the additional steps that are underway.

Brain Implant for Some Blind People Shows Benefits of FDA’s Breakthrough Device Program
Second Sight Medical Products Inc.’s Orion Cortical Visual Prosthesis System recently qualified for the FDA’s voluntary Breakthrough program. The Orion is a brain implant for patients with blindness caused by damage to the optic nerve. With the designation, Second Sight qualified for interactive and timely communication with FDA, even before the Sylmar, Calif., company embarked on a clinical trial to study the device in patients. These early interactions resulted in the development of a flexible study design, review team support, and senior management engagement, all of which may allow a sponsor to evaluate complex, innovative technologies more efficiently.

FDA alerts health care professionals and patients not to use compounded drugs from Cantrell Drug Company; agency seeks action to stop production and distribution
FDA alerted health care professionals and patients not to use drug products produced by Cantrell Drug Company of Little Rock, Arkansas, including opioid products and other drugs intended for sterile injection, that were produced by the company and distributed nationwide. The agency is concerned about serious deficiencies in Cantrell’s compounding operations, including its processes to ensure quality and sterility assurance that put patient safety at risk. Administration of contaminated or otherwise poor quality drug products can result in serious and life-threatening injury or death.

FDA’s ongoing efforts to help improve effectiveness of influenza vaccines
The current influenza season has been especially difficult, causing widespread illness that has affected all fifty states and resulted in a record number of hospitalizations. While healthcare professionals continue to combat this year’s flu – which may continue to affect Americans into April – we’re already partnering with other public health agencies to conduct essential work to produce next season’s influenza vaccines. As part of this process, we’re striving to better understand why we saw reduced effectiveness of this year’s influenza vaccines against one strain of influenza A, called H3N2. It was this strain that caused much of the influenza-related illness this flu season. Moreover, this year is not the first time we have seen vaccines be less effective against this particular strain of influenza, H3N2.

FDA oversees destruction and recall of kratom products; and reiterates its concerns on risks associated with this opioid
FDA announced the voluntary destruction and recall of a large volume of kratom-containing dietary supplements manufactured and distributed nationwide under the brand names Botany Bay, Enhance Your Life and Divinity by Divinity Products Distribution of Grain Valley, Missouri. In cooperation with the FDA, the company has also agreed to stop selling all products containing kratom. Based on the scientific evidence of the serious risks associated with the use of kratom, in the interest of public health, the FDA encourages all companies currently involved in the sale of products containing kratom intended for human consumption to take similar steps to take their products off the market and submit any necessary evidence, as appropriate, to the FDA to evaluate them based on the applicable regulatory pathway. 




FDA approves first tests to screen for tickborne parasite in whole blood and plasma to protect the U.S. blood supply
FDA approved the Imugen Babesia microti Arrayed Fluorescent Immunoassay (AFIA), for the detection of antibodies to Babesia microti (B. microti) in human plasma samples, and the Imugen Babesia microti Nucleic Acid Test (NAT), for the detection of B. microti DNA in human whole blood samples. These tests are intended to be used as donor screening tests on samples from individual human donors, including volunteer donors of whole blood and blood components, as well as living organ and tissue donors.

FDA expands approval of replacement heart valve, smallest mechanical valve size approved in the world
FDA expanded the approval of a heart valve to include a size small enough to be used in newborn pediatric patients to treat heart defects. Specifically, the agency approved the Masters Series Mechanical Heart Valve with Hemodynamic Plus (HP) Sewing Cuff to include the 15-mm valve size, making it the smallest mechanical heart valve approved in the world.

FDA approves new HIV treatment for patients who have limited treatment options
FDA approved Trogarzo (ibalizumab-uiyk), a new type of antiretroviral medication for adult patients living with HIV who have tried multiple HIV medications in the past (heavily treatment-experienced) and whose HIV infections cannot be successfully treated with other currently available therapies (multidrug resistant HIV, or MDR HIV).Trogarzo is administered intravenously once every 14 days by a trained medical professional and used in combination with other antiretroviral medications.

FDA authorizes, with special controls, direct-to-consumer test that reports three mutations in the BRCA breast cancer genes 
FDA authorized the Personal Genome Service Genetic Health Risk (GHR) Report for BRCA1/BRCA2 (Selected Variants). It is the first direct-to-consumer (DTC) test to report on three specific BRCA1/BRCA2 breast cancer gene mutations that are most common in people of Ashkenazi (Eastern European) Jewish descent. These three mutations, however, are not the most common BRCA1/BRCA2 mutations in the general population. The test analyzes DNA collected from a self-collected saliva sample, and the report describes if a woman is at increased risk of developing breast and ovarian cancer, and if a man is at increased risk of developing breast cancer or may be at increased risk of developing prostate cancer. The test only detects three out of more than 1,000 known BRCA mutations. This means a negative result does not rule out the possibility that an individual carries other BRCA mutations that increase cancer risk.

For more information on drug approvals or to view prescribing information and patient information, please visit Drugs at FDA or DailyMed


Methylprednisolone Sodium Succinate for Injection 40mg, 125mg, and 1g by Sagent Pharmaceuticals: Recall - High Out of Specification Impurity Results 
An elevated impurity has the potential to decrease effectiveness of the product in patients.

Hydromorphone HCL Injection USP by Hospira: Recall - Potential For Empty Or Cracked Glass Vials
Use of or exposure to cracked units may be associated with adverse events such as sharps injury to healthcare professionals.

Compounded Drug Products from Cantrell Drug Company: FDA Warning - Serious Deficiencies in Quality and Sterility Assurance
Administration of contaminated or otherwise poor quality drug products can result in serious and life-threatening injury or death.

Bella Diet Capsules by Bella All Natural: Recall - Presence of Sibutramine
Sibutramine and its active metabolites substantially increase blood pressure and/or pulse rate in some patients and may present significant health risks including heart attack, arrhythmia, and stroke.

Cardiac Resynchronization Therapy with Defibrillation (CRT-Ds) and Implantable Cardiovert-Defibrillators (ICDs) by Medtronic: Class I Recall - Manufacturing Error Preventing Electrical Shock Delivery
Delay or inability to deliver a shock to a patient in cardiac arrest or pace a patient’s heart whose heartbeat is too slow could result in serious injury and/or death.

Labetalol Hydrochloride Injection by Hospira: Recall - Potential For Cracked Glass At Rim Surface Of Vials
Cracked vials may result in a lack of sterility assurance. Use of or exposure to a non-sterile product may be associated with adverse events such as fever, chills, sepsis or invasive systemic infections in patients.

Clarithromycin (Biaxin): Drug Safety Communication - Potential Increased Risk of Heart Problems or Death in Patients With Heart Disease 
Prescribers advised to consider using other antibiotics in patients with heart disease.

For important safety information on human drugs, medical devices, dietary supplements and more, or to report an adverse event or problem with a medical product, please visit MedWatch, The FDA Safety Information and Adverse Event Reporting Program.



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.


Gastrointestinal Drugs Advisory Committee Meeting (Mar 8)
The committee will discuss supplemental new drug application (sNDA) 203214, supplement 18, XELJANZ (tofacitinib) 5 mg and 10 mg tablets, submitted by Pfizer Inc., proposed for the treatment of adult patients with moderately to severely active ulcerative colitis who have demonstrated an inadequate response, loss of response or intolerance to corticosteroids, azathioprine, 6-mercaptopurine or tumor necrosis factor (TNF) inhibitor therapy.

FDA’s MedWatch Adverse Event Reporting Program – Opportunities to Collaborate (Mar 13)
This webinar will provide an overview of the Office of Health and Constituent Affairs, identify opportunities to collaborate and advance FDA public health messages and promote public involvement with FDA, describe the FDA MedWatch program, demonstrate how to report adverse events to MedWatch and how to obtain safety information.

Oncology Center of Excellence Listening Session; Public Meeting (Mar 15)
The purpose of the public meeting and the docket for comments is for stakeholders to provide recommendations to the Agency regarding FDA's OCE. Specifically, the Agency solicits comments regarding what stakeholders desire of the OCE in terms of structure, function, regulatory purview, and activity.

Webinar - Duodenoscope Sampling and Culturing (Mar 22)
On February 26, 2018, the U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC) and American Society for Microbiology (ASM), along with other endoscope culturing experts announced the availability of voluntary, standardized protocols that were developed for duodenoscope surveillance sampling and culturing. Hospitals and health care facilities that utilize duodenoscopes can, in addition to meticulously following manufacturer reprocessing instructions, take these additional steps to further reduce the risk of infection and increase the safety of these medical devices. These protocols are an update to the Interim Duodenoscope Surveillance Protocol released by CDC in March 2015. On March 22, 2018, the FDA, CDC, ASM and other endoscope culturing experts will review the voluntary duodenoscope surveillance sampling and culturing protocols, which can be leveraged by facilities to help monitor the quality of their reprocessing procedures. During the webinar, participants will also have an opportunity to ask questions about these voluntary protocols. No registration is required to participate in the webinar.

Pediatric Advisory Committee and Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement (Mar 22)
Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) will meet to discuss the major objectives of a phase 3 drug development program indicated for the treatment of children with achondroplasia (ACH) submitted by BioMarin Pharmaceutical Inc.

Pediatric Advisory Committee Meeting (Mar 23)
Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003. The Pediatric Advisory Committee will meet to discuss the following products: Center for Drug Evaluation and Research: BANZEL, INTUNIV, LEXAPRO
Center for Devices and Radiological Health: FLOURISH (HDE), ACTIVA (HDE), LIPOSORBER (HDE), IMPELLA RP SYSTEM (HDE) 


US FDA and Health Canada: Joint Regional Consultation on the ICH (Apr 6)
FDA and Health Canada will cohost a regional public meeting entitled ‘‘United States Food and Drug Administration and Health Canada Joint Regional Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)’’ to provide information and receive comments on the current activities of ICH as well as the upcoming meetings in Kobe, Japan scheduled for June 4 through 7, 2018. The topics for discussion include the current ICH guideline topics under development that will be discussed at the forthcoming ICH Assembly Meeting in Kobe – see agenda for list of discussion topics. The purpose of this public meeting is to solicit public input prior to the next ICH Assembly meeting and expert working group meetings in Kobe.

CDER Small Business and Industry Assistance Regulatory Education for Industry (REdI): Generic Drugs Forum (Apr 11 -12)
FDA led Regulatory Education for Industry (REdI): Generic Drugs Forum 2018. Join over 1000 participants from across the globe as we gather together in this opportunity to interact with FDA subject matter experts involved in the Generic Drug Review Program. Obtain up-to-date information on program progress and current initiatives.

2018 AAPS Workshop on Drug Transporters in ADME: From the Bench to the Bedside (Apr 16-18)
The 2018 AAPS Transporter Workshop will be the ninth workshop developed to present the next generation of transporters and transport mechanisms that may contribute to absorption, distribution, metabolism and excretion (ADME ) properties of drugs in disease states that should be considered in drug discovery and development. This state-of-the-art workshop will present contributions of heteromeric transporters (ABCG5/G8, ABCD2, OSTα/β) to biliary excretion of cholesterol and disease states, as well as examining intracellular mechanisms of lysosomal sequestration, large molecule transport (antibody, siRNA, antisense RNA) and the current state-of-the-art in transporter imaging, 3D culture models, and in silico approaches to predicting transporter substrate and inhibitor activity.

Peripheral and Central Nervous System Drugs Advisory Committee Meeting (Apr 19)
The committee will discuss new drug application (NDA) 210365, cannabidiol oral solution, sponsored by GW Pharmaceuticals, for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older.

FDA/OCE Public Meeting on Relevant Molecular Targets in Pediatric Cancers: Applicability to Therapeutic Investigation FDARA 2017 (Apr 20)
The FDA Oncology Center of Excellence will hold a public meeting to review and discuss a provisional list of molecular targets to which drugs are being developed for adult cancer indications but which may also be relevant to the growth and/or progression of a cancer which occurs predominantly in children thereby providing a possible rationale for early pediatric evaluation. This meeting is intended for multi-stakeholder participation and input to the Food and Drug Administration as it responds to its FDARA mandate to develop, post on the FDA website, and update regularly such a list to guide sponsors as to which molecular mechanism of action-specific targeted cancer drugs might be considered for early evaluation in children.

12th Annual FDA/DIA Biostatistics Industry and Regulator Forum 2018 (Apr 23-25)
This meeting is intended to be an open forum for the timely discussion of topics of mutual interest to statisticians and clinical trialists who develop new drugs and biologics. A primary focus for this meeting will be to establish an on-going dialogue between industry and regulatory agencies regarding the role of statisticians in implementing the goals and commitments outlined in the sixth authorization of the Prescription Drug User Fee Act.



For more important safety information on human drug and devices or to report a problem to FDA, please visitMedWatch, The FDA Safety Information and Adverse Event Reporting Program

Opportunities for Comment
The FederalRegister.gov website was developed to make it easier for citizens and communities to understand the regulatory process and to participate in Government decision-making. The Office of the Federal Register of the National Archives and Records Administration and the U.S. Government Publishing Office jointly administer the FederalRegister.gov website. 

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.

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.

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.

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.

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.

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.

FDA Voice
FDA voice is the official blog from FDA's senior leadership and staff.

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