FDA Updates for Health Professionals -- August 01, 2012

U.S. Food and Drug Administration
Office of Special Health Issues
10903 New Hampshire Avenue
Silver Spring, Maryland 20993

Dear Colleague,
As part of our ongoing efforts to keep you informed about FDA issues, we want to make you are 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 issues, a brief summary of each issue, and links to detailed information on the FDA Web site.

PRODUCT SAFETY: 

Arrow International, Inc. Multi-Lumen Venous Catheterization Set with Blue FlexTip ARROWg+ard Catheter: Class I Recall – Contains Unlabeled Drug Ingredient (Jul 30)
The device’s labeling erroneously states that the product “contains no medication,” however, the device contains chlorhexidine and silver sulfadiazine.
X-ROCK 3 Day Pill For Men and Z-ROCK: Recall – Undeclared Drug Ingredient (Jul 24)
Finished product of X-ROCK 3 Day Pill for Men and Z-ROCK was tested and found to contain sildenafil and hydroxythiohomosildenafil.
Ampyra (dalfampridine): Drug Safety Communication - Seizure Risk for Multiple Sclerosis Patients (Jul 23)
FDA is updating health care professionals and the public about the risk of seizures in patients with multiple sclerosis who are starting Ampyra (dalfampridine).
--Spanish version: Comunicado de la FDA sobre la seguridad de los medicamentos: Riesgo de convulsiones en pacientes con esclerosis múltiple que toman Ampyra (dalfampridine)
CareFusion EnVe Ventilators: Class I Recall - Leak In Patient Breathing Circuit or System (Jul 20)
A leak may occur in the patient breathing circuit or the system, resulting in the ventilator not holding the set Positive End Expiratory Pressure (PEEP) value either intermittently or continuously.
For more product safety information, please visit our MedWatch website at http://www.fda.gov/medwatch


PRODUCT APPROVALS:

FDA approves Tudorza Pressair to treat chronic obstructive pulmonary disease (Jul 23)
FDA approved Tudorza Pressair (aclidinium bromide) for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.
FDA approves Afinitor for advanced breast cancer (Jul 20)
FDA approved Afinitor (everolimus) for use in combination with Aromasin (exemestane) to treat certain postmenopausal women with advanced hormone-receptor positive, HER2-negative breast cancer.
FDA approves Kyprolis for some patients with multiple myeloma (Jul 20)
FDA approved Kyprolis (carfilzomib) to treat patients with multiple myeloma who have received at least two prior therapies, including treatment with Velcade (bortezomib) and an immunomodulatory therapy.
For information on drug approvals, please visit Drugs@FDA    


OPPORTUNITIES FOR COMMENT AND/OR RECENTLY PUBLISHED GUIDANCES:
Draft Guidance for Industry and Food and Drug Administration Staff - Safety Considerations for 510(k) Submissions to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral ApplicationsThis guidance provides recommendations to manufacturers, FDA reviewers, and other entities involved in submitting or reviewing premarket notification submission [510(k)] for devices that contain small-bore connectors designed for enteral feeding.
Proposed Rule: Unique Device Identification System (UDI) FDA is proposing to establish a unique device identification system to implement the requirement added to the Federal Food, Drug, and Cosmetic Act by section 226 of the Food and Drug Administration Amendments Act of 2007.
Request for Comments: Assessment Program for the Enhanced Review Transparency and Communication for New Molecular Entity New Drug Applications and Original Biologics License Applications in Prescription Drug User Fee Act VFDA is announcing an opportunity for public comment on the statement of work for an assessment of the Program for Enhanced Review Transparency and Communication for New Molecular Entity (NME) New Drug Applications (NDAs) and Original Biologics License Applications (BLAs) (the Program). Submit electronic or written comments by August 6, 2012.
Draft Guidance for Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use — Labeling for Products That Contain Acetaminophen This draft guidance provides drug manufacturers alternative liver warning labeling to minimize potential consumer confusion and to ensure appropriate dosing of over-the-counter acetaminophen-containing products. Submit either electronic or written comments on the draft guidance by September 4, 2012.
Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence RecommendationsFDA is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. Submit either electronic or written comments on the draft and revised draft product-specific BE recommendations listed in this notice by August 13, 2012.
Reclassification from schedule 3 to 2, of combination hydrocodone productsOctober 29-30, 2012 Drug Safety and Risk Management (DsaRM) Advisory Committee Meeting will discuss the reclassification from schedule 3 to 2, of combination hydrocodone products. The Committee will discuss the potential for abuse of drugs containing hydrocodone either combined with other analgesics or as an antitussive.  FDA opened docket number FDA-2012-N-0548. Submit comments by November 6, 2012.
Draft Guidance for Industry and Food and Drug Administration Staff - Pediatric Information for X-ray Imaging Device Premarket NotificationsThe Agency intends for this guidance to minimize uncertainty during the premarket review process of 510(k)s for x-ray imaging devices for pediatric use, to encourage the inclusion of pediatric indications for use for x-ray imaging device premarket notifications, and to provide recommendations on information to support such indications. Submit either electronic or written comments by September 7, 2012.

ANNOUNCEMENTS: 

Tubing and Luer Misconnections: Preventing Dangerous Medical Errors (Jul 26)
This website explains how misconnections occur, provides real-life examples of misconnections, and offers tips and additional resources4 for preventing them.
FDA: More than 150 antiretroviral drugs available through PEPFAR for worldwide HIV/AIDS relief (Jul 23)
FDA Commissioner Margaret A. Hamburg announced the agency has approved or tentatively approved a total of 152 antiretroviral drugs in association with the President’s Emergency Plan for AIDS Relief (PEPFAR) to treat those infected with HIV/AIDS in countries that lack the tools needed to fight the AIDS epidemic.
Consumer Updates: Timely and easy-to-read articles covering all FDA activities and regulated products
- Improving Access to HIV/AIDS Drugs Abroad


UPCOMING MEETINGS: 

Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting (Aug 8)
The committee will discuss the uses and limitations of in vitro dissolution testing and propose future direction for evaluation including possible research and the committee will receive an update on the FDA’s draft guidances for industry on biosimilar products.
Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting (Aug 9)
The committee will discuss FDA's draft guidance on tablet scoring and the Nanotechnology Risk Management Working Group activities.
Gastrointestinal Drugs Advisory Committee Meeting (Aug 28)
Abbott's Humira, for reducing signs and symptoms, and achieving clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy.
Anti-Infective Drugs Advisory Committee Meeting (Sept 5)
Novartis Pharmaceutical's tobramycin inhalation powder for the management of cystic fibrosis patients infected with the bacterium Pseudomonas aeruginosa.
FDA 2nd Annual Health Professional Organizations Conference (Oct 4)
The aim of the conference is to further the public health mission of the FDA through training, collaboration, and structured discussion between health professional organizations and FDA staff.
Drug Safety and Risk Management Advisory Committee Meeting (Oct 29-30)
Discuss the public health benefits and risks, including the potential for abuse, of drugs containing hydrocodone either combined with other analgesics or as an antitussive.
Please visit FDA’s Advisory Committee page to obtain advisory committee meeting agendas, briefing materials, and meeting rosters prior to the meetings. You may also visit this page after meetings to obtain transcripts, presentations, and voting results. For additional information on other agency meetings please visit Meetings, Conferences, & Workshops.


RESOURCES: 

Continuing Education
Safe Disposal CE - Continuing Education Program for Nurses: August 23, 2012
Mark your calendar for the upcoming continuing education program, “Safe Disposal of Medications and Sharps in the Home Setting”, a joint effort of the American Nurses Association and FDA.
Medscape CME/CE: Your Patient Has an Adverse Reaction to a Drug: How to Report to FDA's MedWatch (Released Jul 9)
How to report safety issues to the FDA and how these reports are used to ensure safe use of drugs and medical products
Medscape CME/CE: Introducing the REMS Program for the Transmucosal Immediate-Release Fentanyl Products (Released Jun 29)
The goal of this activity is to provide education about the risk evaluation and mitigation strategy for the transmucosal immediate-release fentanyl products.
Medscape CME/CE: Risk Evaluation and Mitigation Strategies: An Introduction for Physicians, Nurses, and Pharmacists (Released May 15)
The goal of this activity is to provide education to clinicians and pharmacists about risk evaluation and mitigation strategies.
FDA's Clinical Investigator Training CourseTo help develop a cadre of well-trained investigators, FDA has launched a Clinical Investigator Training Course targeted at medical professionals (experts who sign FDA Form 1572 before participating in an investigation).
Videos
A Short Tutorial on REMS: The FDA Perspective
Featuring Dr. Gerald Dal Pan, Acting Director, FDA Office of Surveillance and Epidemiology in the Center for Drug Evaluation and Research
Other Resources
MedSun Medical Product Safety NetworkThe Medical Product Safety Network (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.
For Health ProfessionalsAdditional information for Health Professionals may be found on FDA’s Health Professional website.
 
FDA VoiceFDA Voice is the official blog from FDA's senior leadership and staff.
- FDA Voice Interviews Michelle Yeboah, Dr.P.H., Director of FDA’s Office of Minority Health



Best regards,
Health Professional Liaison Program
Office of Special Health Issues
Food and Drug Administration