As part of our ongoing efforts to keep you informed about FDA, the Office of Health and Constituent Affairs wants to make you aware of recent safety alerts, announcements, opportunities to comment on policy issues, product approvals, upcoming meetings, and resources. We have included a list of the topics with a brief summary and links to detailed information on the FDA Web site.

November 19, 2014

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Just Culture and MedWatch: Safety, Quality, and Transparency Webinar Join the American Nurses Association and the FDA for a complimentary webinar with continuing education credit. Errors in healthcare can result in blame, shame, loss of reputation, and disciplinary action for health care providers, not to mention harm to patients. Therefore, errors are often under-reported.  More information

PRODUCT SAFETY

FDA ChangesTherapeutic Equivalence of Two Generic Versions of Concerta Based on an analysis of data, FDA has concerns about whether or not two approved generic versions of Concerta tablets (methylphenidate hydrochloride extended-release tablets), used to treat attention-deficit hyperactivity disorder in adults and children, are therapeutically equivalent to the brand-name drug. The two approved generic versions of Concerta are manufactured by Mallinckrodt Pharmaceuticals and Kudco Ireland Ltd. More information

October 2014 Safety Labeling Changes

Health professionals from the Office of Health and Constituent Affairs compiled FDA safety information from the month of October including 37 products with revisions to prescribing information. More information

Long-term Antiplatelet Therapy: Safety Announcement - Preliminary Trial Data Shows Benefits But a Higher Risk of Non-Cardiovascular Death

FDA is evaluating preliminary data from a clinical trial showing that treatment for 30 months with dual antiplatelet blood-thinning therapy decreased the risk of heart attacks and clot formation in stents, but there was an increased overall risk of death compared to 12 months of treatment. More information 

Gel-E Donut and Squishon 2 Products by Children’s Medical Ventures: Recall - Potential Mold Contamination

The Gel-E Donut gel pillow and Squishon 2 gel cushions are intended to help support an infant’s head or body in a hospital environment. The products are intended to be used in Neonatal Intensive Care Units (NICU), Pediatric Intensive Care Units (PICU), and neonatal care centers. More information

Nellcor Puritan Bennett, 980 Ventilator System: Class I Recall - Software Issue May Stop Ventilator

The ventilator provides constant breathing support for adults, children, and premature babies that weigh at least 10.6 ounces. The ventilator is used in hospitals or during patient transport.  More information

GemStar Power Supply, 3VDC for GemStar Infusion Pumps by Hospira: Class I Recall - Power Supply May Not Deliver Enough Electricity

If the power supply fails, planned infusion therapy may be delayed if a backup power supply is not used. More information

ABC Dophilus Powder by Solgar, Inc: Recall - Risk of Infection

The product was found to contain Rhizopus oryzae, which may cause health problems to consumers, particularly premature infants/infants, children, and those with weakened immune systems. More information

Mayhem: Public Notification - Undeclared Drug Ingredients

FDA is advising consumers not to purchase or use Mayhem, a product labeled as a dietary supplement that is promoted to increase appetite and muscle growth, because it contains an undeclared corticosteroid and antihistamine. More information

Need Safety Information? For more important safety information on human drugs, medical devices, dietary supplements and more, please visit MedWatch. To receive MedWatch Safety Alerts by emailsubscribe here. Problem With a Medical Product?  Tell FDA about problems with human drugs, medical devices and more using the MedWatch Online Voluntary Reporting Form

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

PRODUCT APPROVALS & CLEARANCES

There were no new FDA approvals since our last newsletter posted on November 5th. 

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

OPPORTUNITIES FOR COMMENT / GUIDANCES

Rare Pediatric Disease Priority Review Vouchers, Draft Guidance for Industry This program is intended to encourage development of new drug and biological products for prevention and treatment of certain rare pediatric diseases. More information

Prescription Drug Marketing Act of 1987; Administrative Procedures, Policies, and Requirements

This notice solicits comments on the information collection in the regulations on the Prescription Drug Marketing Act of 1987; Administrative Procedures, Policies, and Requirements. More information

Spousal Influence on Consumer Understanding of and Response to Direct-To-Consumer Prescription Drug Advertisements

This study will examine differences between consumers viewing prescription drug ads with a spouse or partner versus alone through empirical research. More information

Impact of Ad Exposure Frequency on Perception and Mental Processing of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Ads

This project will examine the effects of variation in ad exposure frequency on perception and mental processing of risk and benefit information in direct-to-consumer (DTC) prescription drug ads. More information

Comment Request: Experimental Studies on Consumer Perceptions of Modified Risk Tobacco Products

The term “modified risk tobacco product” means any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products. More information

Proposed Criteria for “First Generic” Submissions for Purposes of Abbreviated New Drug Application Review Prioritization Under the Generic Drug User Fee Amendments

Establishing clear criteria for this review prioritization category will allow FDA to appropriately prioritize ANDA submissions and track them in a manner consistent with the review prioritization commitments FDA made under GDUFA. Clear criteria for this category will also lead to less industry confusion and more consistent identification of “first generic” submissions. More information

ANNOUNCEMENTS

FDA's Hamburg on Balancing the Risks, Benefits for 310M Patients Eric Topol, Editor-in-Chief of Medscape, interviews Dr Margaret Hamburg, commissioner of the FDA as part of their series on the most interesting people in medicine. More information

Drug Quality: Postmarket Sampling and Testing

FDA's requirements for approval of new and generic drugs and biologics are among the highest standards across the globe. Prior to FDA approval, the manufacturer must prove the product is safe, effective, and high quality. More information

Mind the Gap: Strengthening Relations with the European Medicines Agency

EMA is an important partner for the FDA: It coordinates a network of 4,500 European scientists and evaluates and supervises human and animal medicines for more than 500 million people in 31 countries. More information

FDA Addresses a Critical Public Health Need – Prevention of Serogroup B Meningococcal Disease

Over the last year and a half, there have been numerous reports about outbreaks of bacterial meningitis on several college campuses. Invasive meningococcal disease is a life-threatening illness caused by the bacterium Neisseria meningitidis that infects the bloodstream (sepsis) and the lining that surrounds the brain and spinal cord (meningitis). N. meningitidis is a leading cause of bacterial meningitis, which can have devastating consequences.  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.

Anesthetic and Analgesic Drug Products Advisory Committee (November 24-25)

The committee will discuss the risk of serious neurologic adverse reactions associated with epidural steroid injections (ESI) administered to reduce inflammation for pain management. The committee will also consider the efficacy of ESI and the overall risk benefit balance of injecting steroids in the epidural space to treat pain. These considerations will assist the Agency in our discussions of possible regulatory options, including but not limited to changes to the product labeling. More information

Blood Products Advisory Committee (December 2-3)

The Committee will meet in open session to hear scientific data related to reconsideration of the current blood donor deferral policy for men who have had sex with another man (MSM) even one time since 1977.  In the afternoon, an informational presentation will be made regarding the emergence of chikungunya virus infections in the Western Hemisphere and potential implications for blood transfusion safety.  The Committee will also hear an informational presentation on the first survey of the Rapid Donor Surveillance (RapidDOS) project on Middle Eastern Respiratory Syndrome coronavirus (MERS-CoV). More information

Anti-Infective Drugs Advisory Committee (December 4)

The committee will discuss issues related to clinical development programs and clinical trial designs for antibacterial products for the treatment of patients with serious bacterial infections for which there are limited or no therapeutic options. More information

Electronic Cigarettes and the Public Health - Public Workshop (December 10-11)

The workshop will include presentations and panel discussions about the current state of the science, and will focus on product science, packaging, constituent labeling, and environmental impacts. FDA intends to follow this workshop with two additional electronic cigarette workshops, with one on individual health effects and one on population health effects. More information

Pediatric Oncologic Subcommittee of the Oncologic Drugs Advisory Committee (December 11)

Information will be presented to gauge investigator interest in exploring potential pediatric development plans for three products in various stages of development for adult cancer indications. More information

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee (December 12)

The committee will discuss, make recommendations, and vote on information regarding the premarket approval application for the Superion InterSpinous Spacer device sponsored by Vertiflex Incorporated.More information

Food Advisory Committee Meeting (December 16-17)

The committee will discuss science issues surrounding susceptible life stages or populations and the circumstances under which FDA might decide to conduct a separate risk assessment for these populations. Also, FDA is requesting advice from the Food Advisory Committee on how to integrate concern for susceptible populations into its risk assessment procedures and methodologies including under what conditions a separate risk assessment should be conducted. More information

RESOURCES

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.