FDA Updates for Health Professionals -- May 9, 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: 
Revlimid (lenalidomide): Ongoing Safety Review - Increased Risk of Developing New Malignancies (May 7)
FDA notified the public of an increased risk of second primary malignancies in patients with newly-diagnosed multiple myeloma who received Revlimid.
Victrelis (boceprevir) and Ritonavir-Boosted Human Immunodeficiency Virus (HIV) Protease Inhibitor Drugs: Drug Safety Communication - Drug Interactions (Apr 26)
FDA notified healthcare professionals that the Victrelis drug label has been revised to state that co-administration of Victrelis (boceprevir), a hepatitis C virus protease inhibitor, along with certain ritonavir-boosted human immunodeficiency virus protease inhibitors, is not recommended.
For more product safety information, please visit our MedWatch website at http://www.fda.gov/medwatch


PRODUCT APPROVALS:
FDA permits marketing of a new device for abdominal surgery (May 1)
FDA allowed marketing of the first surgical instrument set that can be assembled and disassembled inside the body during surgery.
FDA approves new orphan drug to treat a form of Gaucher disease (May 1)
FDA approved Elelyso (taliglucerase alfa) for long-term enzyme replacement therapy to treat a form of Gaucher disease, a rare genetic disorder.
FDA approves new antibacterial treatment for plague (Apr 27)
FDA approved Levaquin (levofloxacin) to treat patients with plague, a rare and potentially deadly bacterial infection.
FDA approves Stendra for erectile dysfunction (Apr 27)
FDA approved Stendra (avanafil), a new drug to treat erectile dysfunction.
FDA approves Votrient for advanced soft tissue sarcoma (Apr 26)
FDA approved Votrient (pazopanib) to treat patients with advanced soft tissue sarcoma who have previously received chemotherapy.
FDA approves Afinitor for non-cancerous kidney tumors caused by rare genetic disease (Apr 26)
FDA approved Afinitor (everolimus), the first drug approved specifically to treat non-cancerous kidney tumors not requiring immediate surgery in patients with tuberous sclerosis complex.
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 - 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 on the draft guidance by September 7, 2012.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Revisions to Labeling Requirements for Blood and Blood Components, Including Source PlasmaUnder this rulemaking, FDA is consolidating the regulations related to labeling blood and blood components.  Fax written comments on the collection of information by May 25, 2012.
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Decision Analysis: A Risk-Tolerance Pilot StudyThis notice solicits comments on the survey entitled “Medical Device Decision Analysis: A Risk-Tolerance Pilot Study.”  Submit either electronic or written comments by June 18, 2012.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry, FDA Staff, and Foreign Governments: Fiscal Year 2012 Medical Device User Fee Small Business Qualification and CertificationThis notice solicits comments on Form FDA 3602 and Form FDA 3602A, which will allow domestic and foreign applicants to certify that they qualify as a “small business” and pay certain medical device user fees at reduced rates.  Submit either electronic or written comments by June 18, 2012.
Proposed Collection; Comment Request; Financial Disclosure by Clinical InvestigatorsThis notice solicits comments on information collection on financial disclosure by clinical investigators. Submit either electronic or written comments by May 29, 2012.
Comment Request; Experimental Study of Graphic Cigarette Warning Labels
This notice solicits comments on the Experimental Study of Graphic Cigarette Warning Labels that is being conducted in support of the graphic label provision of the Family Smoking Prevention and Tobacco Control Act.  Submit either electronic or written comments by May 29, 2012.
Comment Request; Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act This notice solicits comments on the collection of information associated with adverse event reporting and recordkeeping for dietary supplements as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act.  Submit either electronic or written comments by May 22, 2012.
Draft Guidance for Industry: Direct-to-Consumer Television Advertisements -- FDAAA DTC Television Ad Pre-Dissemination Review Program 
This draft guidance is intended to assist sponsors of human prescription drug products, including biological drug products, who are subject to the pre-dissemination review of television advertisements provision of the FD&C Act. Submit either electronic or written comments by May 14, 2012.
Draft Guidance for Industry on Limiting the Use of Certain Phthalates as Excipients in Center for Drug Evaluation and Research-Regulated Products 
This draft guidance provides the pharmaceutical industry with CDER's current thinking on the potential human health risks associated with exposure to DBP and DEHP. Submit either electronic or written comments on the draft guidance by May 31, 2012.

ANNOUNCEMENTS: 

FDA proposal aims to help reduce unnecessary radiation exposure for children (May 9)
FDA announced that it is seeking public comment on a proposal encouraging manufacturers to consider the safety of children in the design of new X-ray imaging devices.
FDA Launches New E-Lists for Cardiovascular Disease and Diabetes (May 7)
Sign up to receive FDA updates on safety and regulatory issues related to Cardiovascular Disease and Diabetes, including product approvals, safety warnings, notices of upcoming public meetings, and notices about proposed regulatory guidances.
FDA issues final rule on sterility testing of biological products (May 3)
FDA issued its final rule on sterility testing, amending the requirements for most licensed biological products. The action follows a retrospective review of agency regulations to promote improvement and innovation and is in response to Executive Order 135631 that is designed to improve regulation and regulatory review.
FDA challenges marketing of DMAA products for lack of safety evidence (Apr 27)
FDA issued warning letters to ten manufacturers and distributors of dietary supplements containing dimethylamylamine, more popularly known as DMAA, for marketing products for which evidence of the safety of the product had not been submitted to FDA.
Webinar: Practical Advice for Preventing Surgical Fires--Safety Strategies from the Front Lines (Apr 26)
FDA experts will briefly discuss the ‘Preventing Surgical Fires’ Initiative. Invited hospital staff will share their experiences and protocols used to prevent surgical fires. Surgical Fire prevention recommendations will also be presented.     
Recent Spanish versions of Drug Safety Communications: (Given various time and review constraints, availability of Spanish language versions of Drug Safety Communications will generally follow the English version by about 1-2 weeks.)
- Comunicado de la FDA sobre la seguridad de los medicamentos: Información actualizada sobre la interacción entre el medicamento Victrelis (boceprevir) y ciertos medicamentos reforzados inhibidores de la proteasa del VIH
- Comunicado de la FDA sobre la seguridad de los medicamentos: Nueva advertencia y contraindicación sobre medicamentos para la presión arterial que contienen aliskiren

UPCOMING MEETINGS: 
Endocrinologic and Metabolic Drugs Advisory Committee Meeting (May 10)
Antiviral Drugs Advisory Committee Meeting (May 10)
Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting (May 10-11)
Antiviral Drugs Advisory Committee Meeting (May 11)
Public Hearing on Draft Guidances Relating to the Development of Biosimilar Products (May 11)
Preparation for International Conference on Harmonization Steering Committee and Expert Working Group Meetings in Fukuoka, Japan; Regional Public Meeting (May 14)
Workshop on Natural History Studies of Rare Diseases (May 16-17)
FDA Working with Patients to Explore Benefit/Risk: Opportunities & Challenges (May 18)
Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting (May 24)
Peripheral and Central Nervous System Drugs Advisory Committee Meeting (May 24)
Scientific Workshop on the Assessment of Analgesic Treatment of Chronic Pain (May 30-31)
Regulation of Pharmaceuticals: A Global Perspective (Jun 6-8)
Risk Evaluation and Mitigation Strategy (REMS) Assessments: Social Science Methodologies to Assess Goals Related to Knowledge, Public Workshop (Jun 7)
 
RESOURCES:
 
Articles 

Statins: The Story Behind the Label Changes
Videos

A Short Tutorial on REMS: The FDA PerspectiveFeaturing Dr. Gerald Dal Pan, Acting Director, FDA Office of Surveillance and Epidemiology in the Center for Drug Evaluation and Research
Podcasts
Updated information on drug interactions between Victrelis (boceprevir) and certain boosted HIV protease inhibitor drugs
Safety review update of cancer drug Revlimid (lenalidomide) and risk of developing new types of malignancies
Consumer Updates
Indoor Tanning: The Risks of Ultraviolet Rays
FDA Voice-  the official blog from FDA's senior leadership and staff
Six Month Check-Up: FDA’s Work on Drug Shortages (May 3)



Best regards,

Office of Special Health Issues
Food and Drug Administration