UPDATES FOR HEALTH PROFESSIONALS

Office of Health and Constituent Affairs

ANNOUNCEMENTS

FDA requests removal of Opana ER for risks related to abuse

FDA requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks. This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse. More information

#IAmHHS: Fighting Misleading Prescription Drug Ad Claims

These days, you can hardly turn a magazine page, watch a TV show or sit in the lobby of your doctor’s office without seeing advertising and promotions for prescription drugs. They’re everywhere you go. And they tend to be impressive and reassuring. But are they accurate? Mike Sauers from FDA's Office of Prescription Drug Promotion explains. More information

FDA is taking new steps to help assess opioid drugs with abuse-deterrent properties - Statement from FDA Commissioner Scott Gottlieb, M.D.

Last month, I asked my colleagues at the FDA to identify what additional and more forceful steps the FDA can take, on top of the vigorous work the agency is already doing, to address the crisis of opioid addiction. Everyone at the FDA is committed to focusing on all aspects of the epidemic. The new policy steps that we announced included the formation of a steering committee to examine additional regulatory and policy actions that we can take to combat this crisis. This steering committee will place particular emphasis on evaluating efforts we can take to reduce the number of new cases of addiction. More information

FDA Intends to Extend Compliance Dates for Nutrition Facts Label Final Rules

In May 2016, the U.S. Food and Drug Administration finalized the Nutrition Facts and Supplement Facts Label and Serving Size final rules and set the compliance date for July 26, 2018, with an additional year to comply for manufacturers with annual food sales of less than $10 million. After those rules were finalized, industry and consumer groups provided the FDA with feedback regarding the compliance dates. After careful consideration, the FDA determined that additional time would provide manufacturers covered by the rule with necessary guidance from FDA, and would help them be able to complete and print updated nutrition facts panels for their products before they are expected to be in compliance.

As a result, the FDA intends to extend the compliance dates to provide the additional time for implementation. The framework for the extension will be guided by the desire to give industry more time and decrease costs, balanced with the importance of minimizing the transition period during which consumers will see both the old and the new versions of the label in the marketplace. The FDA will provide details of the extension through a Federal Register Notice at a later time. 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 expands use of Sapien 3 artificial heart valve for high-risk patients

FDA approved approved an expanded indication for the Sapien 3 Transcatheter Heart Valve (THV) for patients with symptomatic heart disease due to failure of a previously placed bioprosthetic aortic or mitral valve whose risk of death or severe complications from repeat surgery is high or greater. 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.

Eliquis (apixaban) 5 mg tablets: Recall One Lot- Bottle labeled as Eliquis 5 mg was found to contain Eliquis 2.5 mg tablets

Bristol-Myers Squibb Company is voluntarily recalling one lot (#HN0063) of Eliquis 5 mg tablets to the consumer level. This lot was distributed nationwide in the U.S. to wholesalers and retail pharmacies in February 2017. Bristol-Myers Squibb is taking this precautionary measure based on a customer complaint that a bottle labeled as Eliquis 5 mg was found to contain Eliquis 2.5 mg tablets. More information

LeadCare Testing Systems (with Blood Obtained from a Vein) by Magellan Diagnostics: FDA Safety Communication - Risk of Inaccurate Results

UPDATED 06/06/2017: Class I Recall expanded to include two additional testing systems; LeadCare and LeadCare II Blood Lead Testing Systems (all serial and lot numbers).

The U.S. Food and Drug Administration and Centers for Disease Control and Prevention are warning Americans that certain lead tests manufactured by Magellan Diagnostics may provide inaccurate results for some children and adults in the United States. Falsely lower test results may lead to improper patient management and treatment for lead exposure or poisoning. More information

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

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.

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

Data and Methods for Evaluating the Impact of Opioid Formulations with Properties Designed to Deter Abuse in the Postmarket Setting: A Scientific Discussion of Present and Future Capabilities (Jul 10-11)

The purpose of the public workshop is to host a scientific discussion with expert panel members and interested stakeholders about the challenges in using the currently available data and methods for assessing the impact of opioid formulations with abuse-deterrent properties on opioid misuse, abuse, addiction, overdose, and death in the postmarket setting. The goal of this meeting is to discuss ways to improve the analysis and interpretation of existing data, as well as to discuss opportunities and challenges for collecting and/or linking additional data to improve national surveillance and research capabilities in this area. More information

Oncologic Drugs Advisory Committee Meeting (Jul 11-12-13)

On July 11, the committee will discuss biologics license application (BLA) 761060, MYLOTARG (gemtuzumab ozogamicin) for intravenous use, submitted by Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. The proposed indication (use) for this product is in combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of adult patients with previously untreated, de novo acute myeloid leukemia (AML).

On July 12, the committee will discuss biologics license application (BLA) 125646 for tisagenlecleucel-T suspension for intravenous use. The application was submitted by Novartis Pharmaceuticals Corp. The proposed indication (use) for this product is for the treatment of pediatric and young adult patients 3 to 25 years of age with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL).

On July 13, during the morning session, the committee will discuss biologics license application (BLA) 761028 for ABP 215, a proposed biosimilar to Genentech/Roche’s AVASTIN (bevacizumab), submitted by Amgen Inc. During the afternoon session, the committee will discuss biologics license application (BLA) 761074 for MYL-1401O, a proposed biosimilar to Genentech Inc.’s HERCEPTIN (trastuzumab), submitted by Mylan GmbH. More information

Vaccines and Related Biological Products Advisory Committee (Jul 28)

On July 28, 2017, the Vaccines and Related Biological Products Committee (VRBPAC) will meet in an open session to discuss and make recommendations on the safety and efficacy of a Hepatitis B Vaccine manufactured by Dynavax. More information

RESOURCES

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