FDA Updates for Health Professionals

December 5, 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 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:

Recall of Life Pulse High-Frequency Ventilator Patient Circuits by Bunnell Inc. (Dec 5)
 The heater wire insulation can melt, causing sparking and smoke close to the humidifier cartridge.  

 

Ondansetron (Zofran) 32 mg, Single Intravenous (IV) Dose Removed Due to Potential For Serious Cardiac Risks (Dec 4)
These drugs are sold pre-mixed in solutions of either dextrose or sodium chloride in plastic containers used to prevent chemotherapy-induced nausea and vomiting. They will no longer be marketed because of the risk of QT interval prolongation, which can lead to Torsades de Pointes, an abnormal, potentially fatal heart rhythm. 

Recall of Mindray A3 and A5 Anesthesia Delivery System Due to Gasket Leak (Nov 30)
The systems are used to administer continuous or intermittent general anesthesia gases and maintain a patient’s breathing during surgery may have a gasket leak which could cause an interruption of or inadequate patient anesthesia and ventilation.

Voluntary Recall of Certain GlideScope GVL Video Laryngoscope Reusable Blades by Verathon Inc. (Nov 29)
The reusable blades, manufactured between December 2010 and August 2011, are prone to developing cracks and/or breaking across the tip of the blade.

Recall of Atorvastatin Calcium Tablets by Ranbaxy Inc. Due to Foreign Substance (Nov 28)
The product is used to lower blood cholesterol and there are 41 affected lots of tablets (10 mg, 20 mg and 40 mg) packaged in plastic bottles with 90 and 500 tablets.

Recall of Isovue (iopamidol injection) Pre-Filled Power Injector Syringes by Bracco Diagnostics Inc. Due to Particulates (Nov 28)
Isovue is indicated for angiography throughout the cardiovascular system, and arterial injection of Isovue (for cerebral angiography) with particulate matter formation could cause stroke.

Please visit our MedWatch website for more information.

 
PRODUCT APPROVALS:

FDA Approves Cometriq To Treat Rare Type Of Thyroid Cancer (Nov 29)
FDA approved Cometriq (cabozantinib) to treat medullary thyroid cancer that has spread to other parts of the body (metastasized).

Please visit Drugs@FDA for more information.



OPPORTUNITIES FOR COMMENT AND/OR RECENTLY PUBLISHED GUIDANCES:

Request for Notification From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representatives and Request for Nominations for Nonvoting Industry Representatives on the Device Good Manufacturing Practice AdvisoryCommittee
All letters of interest and nominations should be submitted in writing by January 3, 2013.

Antiseptic Patient Preoperative Skin Preparation Products; Public Hearing; Request for Comments
FDA will be holding a public hearing to obtain input on how to address microbial contamination of patient preoperative skin preparation drug products.Comments will be accepted until February 12, 2013.
Establishing a List of Qualifying Pathogens That Have the Potential To Pose a Serious Threat to Public Health; Public Hearing; Request for Comments
FDA is seeking input on establishing a list of qualifying pathogens (i.e., those that have the potential to pose a serious threat to public health), as required under the Food and Drug Administration Safety and Innovation Act. Submit comments by December 3, 2012. 
Draft Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE Is Needed
The draft guidance announced in this notice is intended to assist institutional review boards, clinical investigators, and sponsors involved in clinical investigations of FDA-regulated products in fulfilling responsibilities related to reviewing the qualifications of investigators, adequacy of research sites, and the determination of whether an investigational new drug application or investigational device exemption is needed in order to assure the protection of the rights and welfare of human subjects in clinical investigations. Comments due by January 22, 2013. 
Guidance for Industry - FDA and Industry Actions on Premarket Notification 510(k) Submissions: Effect on FDA Review Clock and Goals
The Medical Device User Fee Amendments of 2012 authorizes FDA to collect user fees for the review of certain premarket submissions received on or after October 1, 2012, including premarket notification submissions (510(k)s).
Request for Comments: Clinical Development Programs for Disease-Modifying Agents for Peripheral Neuropathy; Public Workshop
FDA will be holding an open public hearing and workshop to further the understanding of the development of disease-modifying agents for the treatment of painful peripheral neuropathies. Comments for the open public hearing due by February 1, 2013. Written comments due by March 1, 2013.

ANNOUNCEMENTS:
FDA Announces Public-Private Partnership To Develop Regulatory Science That Will Speed Patient Access To New Medical Device Technologies (Nov 3)
The new Medical Device Innovation Consortium (MDIC) is an independent, nonprofit corporation, created by LifeScience Alley (LSA), and will prioritize the regulatory science needs of the medical device community and fund projects.


UPCOMING MEETINGS:

December
Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee Meeting (Dec 4)
The Subcommittee will be discussing issues relating to the development of products for pediatric use and provide guidance to facilitate the formulation of written requests for pediatric studies, if appropriate. The four products under consideration are: (1) Trametinib, application submitted by GlaxoSmithKline, LLC; (2) TH-302, application submitted by Threshold Pharmaceuticals, Inc.; (3) volasertib (BI 6727), application submitted by Boehringer Ingelheim Pharmaceuticals, Inc.; and (4) blinatumomab (MT 103), application submitted by Amgen Inc.
Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting (Dec 5-6)
The Committee will discuss and make recommendations regarding the 515(i) order issued by  FDA on April 9, 2009 for the external counter-pulsating (ECP) devices, intra-aortic balloon and control systems, and nonroller-type cardiopulmonary bypass blood pumps, three of the remaining pre-amendment class III devices.
Anesthetic and Analgesic Drug Products Advisory Committee Meeting (Dec 7)
The Committee will discuss the risks and benefits of proposed trade name Zohydro ER (hydrocodone bitartrate extended-release capsules) for the management of moderate to severe chronic pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
Neurological Devices Panel of the Medical Devices Advisory Committee Meeting (Dec 10)
The Committee will discuss current knowledge about the safety and effectiveness of the CoAxia NeuroFlo Catheter device for the intended use of diverting cardiac output to the cerebral vasculature via partial occlusion of the descending aorta, including in patients with acute ischemic stroke within 14 hours of symptom onset.
Antiseptic Patient Preoperative Skin Preparation Products (Dec 12-13)
FDA is interested in obtaining public comment about certain scientific and product use issues related to patient preoperative skin preparations.
Drug Safety and Risk Management Advisory Committee Meeting (Dec 12-13)
On December 12, the Committee will meet to discuss the various strategies used by the Agency to define and address teratogenic risk, including requiring REMS with ETASU. On December 13, the Committee will discuss two common risk management tools used to minimize the risk of teratogens – contraception and pregnancy testing.
Establishing a List of Qualifying Pathogens That Have the Potential to Pose a Serious Threat to Public Health (Dec 18)
This public hearing is being held to obtain comments from the public to determine the methodology that should be used in developing the list of qualifying pathogens, and to elicit suggestions for adding specific pathogens to the list.
Arthritis Advisory Committee Meeting (Dec 20)
The Committee will discuss rintatolimod injection (proposed trade name AMPLIGEN) submitted by Hemispherx Biopharma, Inc. for the treatment of patients with chronic fatigue syndrome.

January
Pulmonary-Allergy Drugs Advisory Committee Meeting (Jan 29)
The committee will discuss olodaterol metered dose inhaler (proposed trade name Striverdi Respimat) by Boehringer Ingelheim, for the treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. 
Pulmonary-Allergy Drugs Advisory Committee Meeting (Jan 30)
The committee will discuss mannitol inhalation powder (proposed trade name BRONCHITOL), by Pharmaxis, for the treatment of cystic fibrosis (CF) in patients aged 6 years and older.
Please visit FDA’s Advisory Committee for more information. Please visit Meetings, Conferences, & Workshops for additional information on other agency meetings.

CONSUMER UPDATES:
Helping Consumers Reduce Sodium Intake
Most Americans consume way too much sodium, with salt (sodium chloride) being the most common form.
Please visit Consumer Updates for more information.


RESOURCES:

2012 Health Professional Organizations Annual Conference -  Meeting Summary
The summary captures highlights and presentations from the Second Annual Health Professional Organizations Conference on October 4, 2012.

FDA Basics Webinar: A Brief Overview of REMS
This presentation will discuss REMS and how they are used to help ensure that the benefits of certain medicines continue to outweigh their risks.
FDA Voice:
FDA Voice is the official blog from FDA's senior leadership and staff.
A New Law Advances Public Health: New Web Page Tracks Progress
Fighting Antibiotic Resistance
MedSun Medical Product Safety Network
The 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. The MedSun Web page is a newsletter-based website which provides monthly updates about timely medical device issues that may impact patient safety.



Best regards,

Office of Special Health Issues
Food and Drug Administration