PharmPAC General Meeting Minutes Page 1 of 23 U.S. PUBLIC HEALTH SERVICE Pharmacist Professional Advisory Committee Department of Health and Human Services Minutes of General Meeting FDA White Oak Conference Room 1419 1400 EST on 07 March 2013 __________________________________________________________________________________________________ Call to Order: CDR Michael Crockett ([email protected]), PharmPAC Chair Meeting began at 1403 EST. Roll Call/Attendance: LCDR Rodney Waite II Name Section OPDIV CITY, STATE PRESENT Alternate PRESENT RADM Scott Giberson CPO DCCPR Rockville, MD Yes N/A N/A CDR Michael Crockett Chair BOP Pollock, LA Yes LCDR Tami Rodriguez LCDR Marisol Martinez Chair-Elect DoD Fort Sam Houston, TX Yes CAPT Nita Sood CAPT Aaron Sigler Career Develop. FDA Rockville, MD Yes LCDR Craig Kiester CDR Kavita Dada Administration FDA Silver Spring, MD AWA LCDR Jennifer Shepherd Yes CDR Janelle Derbis Readiness FDA Chicago, IL Yes CDR William Pierce CDR Jefferson Fredy Career Develop. IHS Crownpoint, NM Yes LT Ashley Burns CDR Jinhee Lee Administration SAMHSA Rockville, MD Yes CDR Alina W. Salvatore CDR Aaron Middlekauff Recruitment DHS-CG Washington, D.C. Yes LCDR Jeffrey Eertmoed CDR Timothy Murray Administration IHS Claremore, OK Yes CDR Dean Goroski Yes CDR Juliette Touré Readiness FDA Silver Spring, MD Yes CDR Diem-Kieu Ngo CDR MaryJo Zunic Communications IHS Albuquerque, NM Yes LCDR Maria Apodaca LCDR Troy Bernardo Readiness BOP Butner, NC Yes LT Anna Stevenson Yes LCDR Tiffanie Dunlevy Career Develop. BOP Marianna, FL Yes LT Zachary Woodward LCDR Brittany Keener Recruitment IHS Anchorage, AK AWA LCDR Christina Eldridge Yes LCDR Kara King Recruitment IHS Anchorage, AK Yes CDR Damion Killsback LCDR Khang Ngo Communications IHS Taholah, WA Yes LCDR Chungah Grace Huggett LCDR Selena Ready N/A FDA Silver Spring, MD Yes CDR Mark Miller LCDR Jodi Tricinella Communications IHS Claremore, OK AWOA LCDR Stephanie Arnold CAPT Greg Dill Associate CMS Chicago, IL Yes N/A CDR Fortin Georges Associate NIH Bethesda, MD Yes N/A CDR Carmen Kelly Associate AHRQ Rockville, MD Yes N/A CDR Lori Hall Associate CDC Atlanta, GA No N/A CDR Timothy Bowman Associate IC Houston, Tx Yes N/A LCDR Kenda Jefferson Associate DHS-OS Washington, D.C. Yes N/A LCDR Liatte Krueger Associate-JOAG FDA Parsipanny, NJ Yes N/A CDR Peter Diak Ex-Officio FDA Silver Spring, MD Yes N/A LCDR Rodney Waite Exec. Secretary BOP Milan, MI Yes N/A AWA = Absent With Alternate; AWOA = Absent WithOut Alternate __________________________________________________________________________________________________
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Call to Order: CDR Michael Crockett ([email protected] ...Mar)_General...o CDR Verna Kuka, Professional Development ([email protected]) o Q: Is an IT degree commissionable? A: It
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PharmPAC General Meeting Minutes Page 1 of 23
U.S. PUBLIC HEALTH SERVICE Pharmacist Professional Advisory Committee
Department of Health and Human Services
Minutes of General Meeting FDA White Oak Conference Room 1419
1400 EST on 07 March 2013 __________________________________________________________________________________________________
Call to Order: CDR Michael Crockett ([email protected]), PharmPAC Chair Meeting began at 1403 EST.
Roll Call/Attendance: LCDR Rodney Waite II Name Section OPDIV CITY, STATE PRESENT Alternate PRESENT
RADM Scott Giberson CPO DCCPR Rockville, MD Yes N/A N/A
CDR Michael Crockett Chair BOP Pollock, LA Yes LCDR Tami Rodriguez
LCDR Marisol Martinez Chair-Elect DoD Fort Sam Houston, TX Yes CAPT Nita Sood
CAPT Aaron Sigler Career Develop. FDA Rockville, MD Yes LCDR Craig Kiester
CDR Kavita Dada Administration FDA Silver Spring, MD AWA LCDR Jennifer Shepherd Yes
CDR Janelle Derbis Readiness FDA Chicago, IL Yes CDR William Pierce
CDR Jefferson Fredy Career Develop. IHS Crownpoint, NM Yes LT Ashley Burns
CDR Jinhee Lee Administration SAMHSA Rockville, MD Yes CDR Alina W. Salvatore
CPO Update & CPO Open Forum: RADM Scott Giberson Please read the March 2013 CPO Report.
Key component of the open forum is the Q&A session, can be random! This is a good venue.
Key Commissioned Corps HQ messages will come through the listserv, based on the e-mails put in Direct Access.
New Dental Plan. Now Delta Dental, starting April 1st, may need to ensure dental provider is provider under this plan. Message about this to go through the aforementioned listserv on 08 March 2013.
Trying to increase the value of the Corps by increasing the value of PHS officers through: o New Hire Process: will not be giving applications UNTIL they go through new pre-screening process that
will further elucidate what the PHS entails o Promotion Cycle 2013: will be tighter going forward. The actual date of board will NOT be announced
as is confidential.
JrCOSTEP list finalized and sent to Secretary.
Eunice Chung-Davies ([email protected]) is new Special Assistant for RADM Scott Giberson.
Q: Any further information of Special Pay for BCPS, etc.? A: It is wrapped up in Consolidated Special Pay, so that it is making it take longer, but it will be approved. Advantage of doing it this way is that if any new certifications come out, having this wording will allow these to fall under it and not need re-approval. This does remain a priority.
Q: Any method of tracking how many are on these calls? A: CDR Touré will check into it.
Q: As Direct Access becomes more what we want, the importance of updating it and adding more fields of information will become more important? A: Yes, definitely. Direct Access will be used in the future to scan Corps for appropriate Officer(s) for a given vacant billet.
Q: Any talk of implementing the three promotions and freeze (“3 and Freeze”)? A: Yes, there are a number of criteria over the course of a career that we want to be looking at in the future to ensure we have right people in the beginning, middle, and end of the career spectrum.
Q: Do we have a Reserve Corp? A: Yes, but just for short term appointments (COSTEP, etc.) at this point, not for response component per OMB. Therefore, we do not have a surge capacity.
Q: Do we see true Force Management coming? A: No, but we can “force shape”. This is because we have to control the budget and have to have a set number of slots/F.T.E.s. We can still manage our careers by picking a vacancy to move into. Getting in will be harder and will have to abide by the standards while in.
MAB Presentation by Dr. Abrams – Medical Waivers o There is a need to have people physically ready for deployment for the people of the Nation. o Basic Readiness Requirements reflect this need and to help officers meet this requirement. o Medical Waiver has been running smoothly. Based on manual circular 377
(ccrf.hhs.gov/ccrf/PHS_NO_377.pdf). o There is a misconception that obtaining a waiver will reflect negatively, but historically, this has not
been the case. It behooves an officer to obtain a waiver if he/she cannot meet a Basic Readiness item. o Medical Waiver FAQ from PharmPAC has some good recommendations and mostly reflects manual
circular 377 (ccrf.hhs.gov/ccrf/PHS_NO_377.pdf). o All the policy for this program is from DCCPR. DCCPR oversees the Medical Affairs Branch (MAB). o President’s Challenge is still around for now, but is so informal and not confirmable. Dr. Abrams’
opinion is that if you need a waiver for President’s Challenge then it maybe a Fitness for Duty issue. o Pharmacist’s often have a lot of knee and lower back injuries from standing a lot. o Permanent Waiver vs. Time-Limited (this is how Manual Circular 377 lists them): Permanent Waiver
does not mean it is permanent, but a longer term waiver. ALL WAIVERs have a time limit! o Length of Waiver: to be determined by your personal physician as they have more data on hand o Q: What if I had an immunization as a child but do not have the documentation?
A: Obtain a waiver, or can get a titer. o Q: How do I start the Medical Waiver process?
A: Put in a request stating you need a waiver first by writing, fax, or e-mail (preferred, especially if can scan/attach documentation from provider that is signed by provider and on office letterhead). Data can come from provider in any format the provider can/will send in, but does not need be a long, drawn-out batch of documentation (i.e. do not all the labs, etc.). We want just the minimum to establish the need for the waiver.
o Q: I just became pregnant, do I need a waiver? A: Yes. Request the waiver as normal (see above). Waiver will cover up to 180 days post-partum. A possible Breastfeeding Waiver in pending approval that would cover after the post-partum (from the normal Pregnancy Waiver). However, the possible Breastfeeding Waiver would not negate the need to complete and APFT, but would exempt an officer from deploying.
o MAB completes about 30-40 waivers per month, about 50% for pregnancy. o Q: If I am denied a medical waiver, then what happens?
A: You can appeal. First appeal goes to the Chief of the Medical Affairs Branch (MAB). Second Appeal goes to the Surgeon General. Have 30 days per denial to appeal. Has not been a big issue. Likely will not win appeal, unless have new information that previous request receiver did not see.
o MAB will not really argue with your provider as we feel that he/she has the training and legal responsibility to conduct care properly.
o A: Are there appeals for immunizations? Q: Yes, just need a note from your provider. Do not need a full workup. This would be a long-term waiver that would need to renewed along with your 5 Year Physical.
o Any questions, then feel free to call Dr. Abrams in MAB at 301-427-3261 __________________________________________________________________________________________________
Recruitment Section Update CDR Aaron Middlekauff ([email protected]) LCDR Brittany Keener ([email protected]) LCDR Kara King ([email protected]) Section Web Address: http://www.usphs.gov/corpslinks/pharmacy/sc_recruit.aspx UPOC volunteers are expected to respond to biannual request for contact information and enter the information to
the UPOC website. Any questions, then please contact CDR Middlekauff or LCDR Keener. Some UPOCs will be receiving a Recruitment Ribbon based on previous participation. See clarification text from section as follows:
o UPOC Expectations and Update (housekeeping notes regarding the UPOC Program) – the next UPOC
Biannual Report will be sent out next month. As a reminder, officer volunteers serving as UPOCs are
expected to maintain at least two points of contact with their assigned university(s). There is also an
expectation to respond back to the UPOC biannual reports ensuring that each officer has accomplished
at least one of the two required contacts, that they have logged their recruitment activities on the
PharmPAC Recruitment Tools Website, that the officer is still interested in continuing with the UPOC
program and inquiring if any of their information has changed. This ensures that responsive and
dedicated officers remain engaged and ready respond and serve. Any questions please e-mail CDR
Middlekauff at [email protected] or call 202-372-4126 at your convenience to discuss.
o UPOC Recruitment Service Ribbon – this was submitted for all active UPOCs that demonstrated the
required documentation from Nov 2008 through June 2012. It was submitted by DCCPR and is awaiting
approval at the Awards Board level. I have been assured that this award will be in officer’s OPF’s by the
time the promotion board meets. Unfortunately there is no mechanism to track the status of the award
once it was submitted. As soon as the Recruitment Section has an update or has further information,
we will disseminate to all officers that were submitted for the award.
USPHS Excellence in Public Health Pharmacy Practice Award – Deadline 08 March 2013. See clarification text from
section as follows:
o USPHS Excellence Award - Deadline for nomination submission for the USPHS Excellence in Public Health
Pharmacy Practice Award is March 8, 2013. Late nominations will NOT be accepted. If you have
Career Development Section Update CAPT Aaron Sigler ([email protected]) CDR Jefferson Fredy ([email protected]) LCDR Tiffanie Dunlevy ([email protected]) Section Web Address: http://www.usphs.gov/corpslinks/pharmacy/sc_career.aspx Career Counseling at COA Symposium: no set date yet. We want to match up officers within same agency and
senior with junior officers. More information upcoming via listserv. __________________________________________________________________________________________________
Readiness Section Update CDR Janelle Derbis ([email protected]) CDR Juliette Touré ([email protected]) LCDR Troy Bernardo ([email protected]) Section Web Address: http://www.usphs.gov/corpslinks/pharmacy/sc_readiness.aspx Thanks to Dr. Abrams for presentation on Medical Waivers.
Medical Waiver FAQ o Being finalized and going through approval process. Will be posted to HHS PharmPAC website and the
PharmPAC Google Fusion Website (https://sites.google.com/site/usphspharmacyreadiness/) o APFT is the ONLY reliable, measurable way to assess physical fitness.
New PharmPAC Google Fusion Website (https://sites.google.com/site/usphspharmacyreadiness/) o Has numerous tools to help you, including SmartPhone Apps, Readiness Check Countdown, Dear Jess
Column for personalized assistance, information on the PACE Program. Thanks to LT Jessica Fox for developing this website.
Award nominations still open. Information sent out via listserv on the nature of the awards, etc. Can find on the PharmPAC website at: http://www.usphs.gov/corpslinks/pharmacy/sc_admin_awards.aspx
PAC Chair Update: CDR Michael Crockett ([email protected]) Facebook page: A Place of Honor for U.S. Public Health Service Pharmacy
o LCDR Selena Ready is the PharmPAC point of contact for the APhA Foundation’s “Paver” project. LCDR Ready can be reached via e-mail at [email protected]
o APhA is honoring Federal Pharmacy by installing special pavers in the National Mall. Donations are needed to help us meet the goal of $5,000 to have them installed, so far we have about 20%.
APhA Conference and the Federal Pharmacy Forum were held March 1st – 4th in Los Angeles, CA. Despite lower than usual attendance the meeting was a tremendous success and, PHS was well represented with over 40 officers in attendance. RADM Giberson was honored to receive the APhA Distinguished Federal Pharmacist award.
2014 Category Benchmarks: Precepts two and three were sent to the CPO by PAC by Benchmark Committee. Precepts one and four were sent from the PAC Chairs Committee to the CPO Board for review and finalization. The complete 2014 Benchmarks will be posted soon once finalized.
Specialty Pay: Compensation Policy Advisory Board has sent forth their recommendations. The process is moving along, but maybe a few more months. Specialty pay remains a priority.
National Prevention Strategy: The pharmacy category will be participating in a Combined Communications Committee at the PAC Chairs level to facilitate communicating between categories including newsletters and to jointly promote the NPS.
PAC Chair-Elect Update: LCDR Marisol Martinez ([email protected] ) Please contact PharmPAC when need assistance, we are here to help.
USPHS Symposium is our only PHS-only event. I highly encourage your attendance, even if need to self-fund. Make sure to bring your running shoes as we will be doing an APFT.
OBC: Highly encouraged to attend pinning ceremonies and/or graduations.
Old/New Business: CDR Michael Crockett ([email protected]) LCDR Khang Ngo - USPHS Symposium Information
With the passing of the 13th U.S. Surgeon General, Dr. C. Everett Koop, COF will be honoring and celebrating the life of Dr. Koop with the first Dr. C. Everett Koop Memorial Lecture, to be delivered by the 17th U.S. Surgeon General, Dr. Richard Carmona on May 21st during the Anchor and Caduceus Dinner. Tickets are available when registering for the Symposium. In addition, there will be a panel discussion featuring former U.S. Surgeons General.
Conference event planners have worked with the Renaissance Hotel to make rooms available for those who would like to stay through Memorial Day weekend, in essence, giving you the opportunity to turn your conference trip into a family vacation. A small number of rooms have been added and more are available if needed. We are currently at more than 75% booking. Be sure to use the group code USPUSPA.
Registration rates will go up after March 19th, so register for the conference now at the early bird rate.
Once again this year, the PharmPAC will offer career counseling sessions during the conference. Stay tuned for more information in the coming months.
Calling all pharmacists in the Phoenix area - If you would like to volunteer in planning the pharmacy social event, please email me directly at [email protected].
The meeting was adjourned at 1529 EST. __________________________________________________________________________________________________
Next Meeting Date: 04 April 2013 from 1400 to 1530 EST
White Oak Conference Room Bldg 22
Room 1419
Agenda and call-in information will be distributed prior to the meeting. __________________________________________________________________________________________________
Pharmacy Category Action Items One Time Tasks (Arranged by Due Date)
Due Date Task
Now Review USPHS Symposium Agendas (Click here for Agenda Page link)
1st week of April National Public Health Week
Before May 21-23 Make Arrangements to attend the USPHS Symposium; Pharmacists can earn up to 13 C.E.U.s!
May 21-23 USPHS Symposium in Glendale, Arizona (see “Old/New Business Above” for more information)
Attend the USPHS Symposium
Participate in the Surgeon General’s Run
November 3rd AMSUS Meeting – Seattle, WA – November 3-8, 2013 Theme: "Federal Healthcare Leading the Way: a future of partnerships in excellence." Vision: An educational venue for the full spectrum of military and federal healthcare professionals. Objectives: * Enhance multi-specialty care across all federal healthcare settings * Discuss advances in the delivery of healthcare services * Present innovative models of care management * Improve practice skills of clinicians, surgeons, researchers and administrators * Facilitate inter-organizational and international exchange * Honor our history and traditions * Recognize outstanding performance throughout Federal Medicine Want to Present? Submit your abstract (see AMSUS attachments)
Continuous Tasks
Task (Frequency)
Review CPO Report and complete its Action Items (Monthly)
PharmPAC Perspectives Newsletter Review new issues (Quarterly) Volunteer to submit articles to the Communication Section (Whenever you can!)
PharmPAC Meetings/Minutes Review previous minutes if missed meeting (Monthly) Review Liaison Reports for Agency Specific Information (Monthly) Attend future meeting (first Thursday of the month at 1400 EST)
Annual Physical Fitness Test (APFT) Use APFT Locator to find an event Complete an APFT (Annually – before last APFT expires)
USPHS Awards (Done annually, generally in March) Review Criteria (http://staging.usphs2.cit.nih.gov/corpslinks/pharmacy/sc_admin_awards.aspx) Nominate eligible officer(s), submitting all material as ONE .pdf to the Administration Section
--Respectfully Submitted, ___Rodney C. Waite II_________________/ __04 April 2013 LCDR Rodney Waite II, Executive Secretary Date ___CDR Michael Crockett_____________/____04 April 2013_ CDR Michael Crockett, Chair Date __________________________________/________________ RADM Scott Giberson, CPO Date
BOP Liaison Report • RADM Chris Bina, CDR Kathleen Dotson and Lt Jacklyn Finocchio have deployed to Saipan, Commonwealth of Northern
Mariana Islands. RADM Bina replaced RADM Kendig as Officer In Charge on Jan 20th, 2013 and will remain for the
duration of the mission.
• The BOP has reached 90 Collaborative Practice Agreements (CPA) in place for 54 pharmacists. Interest and
development of CPAs continues to grow each month. Current CPAs include Anticoagulation, Lipids, HIV,
Aminoglycosides, Erythropoetin Stimulating, HCV, Diabetes, Pain Management and Psychotherapy.
• CAPT Mike Dupree, CDR Mike Crockett, LT Michelle Williams, and LT Stephen Rabe represented the BOP at the
recruitment booth at the APHA conference in Las Angeles.
Page 12 of 23
CDC Liaison Report
March, 2013 Updates MMWR: Interim Adjusted Estimates of Seasonal Influenza Vaccine Effectiveness — United States, February 2013 February 22, 2013 / 62(07);119-123 Early influenza activity during the 2012–13 season enabled estimation of the unadjusted effectiveness of the seasonal influenza vaccine. The report presents updated adjusted estimates based on 2,697 children and adults enrolled in the U.S. Influenza Vaccine Effectiveness (Flu VE) Network during December 3, 2012–January 19, 2013.
CDC Science Clips: Volume 5, Issue 7, February 18, 2013 CDC Science Clips is an online bibliographic digest featuring scientific articles and publications that are shared with the public health community each week, to enhance awareness of emerging scientific knowledge. Below, are some CDC-authored publications related to pharmacy practice:
Receipt of systemic corticosteroids during asthma visits to U.S. emergency departments, 2007-2009 Simon AE, Akinbami LJ. J Asthma. 2013 Feb 12.
Aspirin in the secondary prevention of cardiovascular disease Parekh AK, Galloway JM, Hong Y, Wright JS. N Engl J Med. 2013 Jan 17;368(3):204-5.
Community-onset invasive methicillin-resistant Staphylococcus aureus infections following hospital discharge Duffy J, Dumyati G, Bulens S, Namburi S, Gellert A, Fridkin SK, Lessa FC. Am J Infect Control. 2013 Feb 5.
Community-associated Clostridium difficile infection: how real is it? Lessa FC. Anaerobe. 2013 Feb 8.
CDC Health Advisory: New Carbapenem-Resistant Enterobacteriaceae Warrant Additional Action by Healthcare Providers Because of increased reports of Carbapenem-resistant Enterobacteriaceae (CRE), CDC is alerting clinicians about the need for additional prevention steps regarding CRE. CDC continues to recommend that facilities follow the CDC guidance for preventing the spread of CRE in healthcare settings http://www.cdc.gov/hai/organisms/cre/cre-toolkit/index.html.
CDC Public Health Grand Rounds – Reducing the Burden of HPV-associated Cancer and Disease through Vaccination in the US was held on Tuesday, February 19 and the webcast is now archived for viewing. This program is a
designated event for pharmacists to receive 1.0 Contact Hours in pharmacy education. The next Grand Rounds presentation will be on Teen Pregnancy on Tuesday, March 19th at 1pm EST. Future Grand Rounds topics will include: Immunization.
Vital Signs: Child Injury This month’s Vital Signs report explains that even though child injuries are preventable, more than 9,000 children died from injuries
in the US in 2009. Car crashes, suffocation, drowning, poisoning, fires, and falls are some of the most common ways children are hurt
or killed. The number of children dying from injury dropped nearly 30% over the last decade. However, injury is still the number 1
cause of death among children. Read more about what CDC recommends can be done.
Product marketed as dietary supplement contains drug ingredient Sibutramine, and may present a significant risk to
patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. More information
Omontys (peginesatide) Injection by Affymax and Takeda: Recall of All Lots - Serious
Hypersensitivity Reactions (Feb 23, 2013)
Affymax, Inc. and Takeda Pharmaceutical Company Limited along with FDA are informing the public of a voluntary recall of all lots of OMONTYS® (peginesatide) Injection to the user level as a result of new postmarketing reports regarding serious hypersensitivity reactions, including anaphylaxis, which can be life-threatening or fatal. More information
Vistide (Cidofovir Injection) by Gilead: Recall - Presence Of Particulate Matter(Feb 16, 2013)
Gilead Sciences, Inc. is voluntarily recalling lot B120217A of Vistide® (cidofovir injection) to the user level due to the
presence of particulate matter found in some vials of this lot. More information
Safety Labeling Changes: January 2013 (Feb 8, 2013)
The summary view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. More information
Z Pro High Protein Supplement: Recall - Undeclared Soy And Milk (Feb 4, 2013)
R-Kane Products, Inc, Pennsauken, NJ is recalling all outstanding supplies of its Z PRO HIGH PROTEIN SUPPLEMENT, because it contains soy and milk, allergens which are not declared on the labels of individual packets of the product. More information
For more product safety information, please visit our MedWatch website.
PRODUCT APPROVALS AND CLEARANCES:
FDA approves Osphena for postmenopausal women experiencing pain during sex (Feb 26, 2013)
FDA approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause. More information
FDA approves Stivarga for advanced gastrointestinal stromal tumors (Feb 26, 2013)
FDA expanded the approved use of Stivarga (regorafenib) to treat patients with advanced gastrointestinal stromal tumors (GIST) that cannot be surgically removed and no longer respond to other FDA-approved treatments for this disease. More information
FDA approves new treatment for late-stage breast cancer (Feb 22, 2013)
FDA approved Kadcyla (ado-trastuzumab emtansine), a new therapy for patients with HER2-positive, late-stage (metastatic) breast cancer. More information
FDA approves new silicone gel-filled breast implant (Feb 20, 2013)
FDA approved the Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant to increase breast size (augmentation) in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age. More information
FDA approves first retinal implant for adults with rare genetic eye disease(Feb 14, 2013)
FDA approved the Argus II Retinal Prosthesis System, the first implanted device to treat adult patients with advanced retinitis pigmentosa. More information
FDA Approves Pomalyst for Advanced Multiple Myeloma (Feb 8, 2013)
FDA approved Pomalyst (pomalidomide) to treat patients with multiple myeloma whose disease progressed after being treated with other cancer drugs. More information
FDA Approval of Generic Version of Cancer Drug Doxil is Expected to Help Resolve Shortage (Feb
4, 2013)
FDA approved the first generic version of the cancer drug Doxil (doxorubicin hydrochloride liposome injection). Doxil is currently on FDA’s drug shortage list. For products on the shortage list, the FDA’s Office of Generic Drugs is using a priority review system to expedite the review of generic applications to help alleviate shortages. More information
FDA Approves New Drug for the Chronic Management of Some Urea Cycle Disorders (Feb 1, 2013)
FDA approved Ravicti (glycerol phenylbutyrate) for the chronic management of some urea cycle disorders in patients ages 2 years and older. More information
For more information on drug approvals or to view prescribing information and patient information, please visit
Drugs@FDA or DailyMed
RESOURCES:
Drug Shortages
The information provided in this section is provided voluntarily by manufacturers. 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
FDA Voice
FDA voice is the official blog from FDA's senior leadership and staff. More information
Medical Prouct 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
CONSUMER UPDATES:
Consumer Update: Don’t Double Up on Acetaminophen
More than 600 medications, both prescription and over-the-counter (OTC), contain the active ingredient
acetaminophen to help relieve pain and reduce fever. Taken carefully and correctly, these medicines can be safe
and effective. But taking too much acetaminophen can lead to severe liver damage. More information
Consumer Update: At FDA, Pharmacists Answer Your Call
From their offices in Silver Spring, Md., FDA pharmacists answer thousands of calls to 1-888-INFO-FDA each
year. More information
Please visit Consumer Updates for more information.
NIH Liaison Report Monday, 3/4/2013 - Toddler 'functionally cured' of HIV infection, NIH-supported investigators report A two-year-old child born with HIV infection and treated with antiretroviral drugs beginning in the first days of life no longer has detectable levels of virus using conventional testing despite not taking HIV medication for 10 months, according to findings presented today at the Conference on Retroviruses and Opportunistic Infections (CROI) in Atlanta. The case study was presented at the CROI meeting by Deborah Persaud, M.D., associate professor of infectious diseases at the Johns Hopkins Children’s Center in Baltimore, and Katherine Luzuriaga, M.D., professor of pediatrics and molecular medicine at the University of Massachusetts Medical School in Worcester. “This case suggests that providing antiretroviral therapy within the very first few days of life to infants infected with HIV through their mothers via pregnancy or delivery may prevent HIV from establishing a reservoir, or hiding place, in their bodies and, therefore, achieve a cure for those children,” said Dr. Persaud. NIAID and NICHD provided funding that supported the collaborating investigators involved in the analysis of the HIV-infected child through the International Maternal Pediatric Adolescent AIDS Clinical Trials Network’s (IMPAACT) cooperative agreement grant AI066832. http://www.nih.gov/news/health/mar2013/niaid-04.htm Wednesday 1/9/2013 - Getting to the Bottom of Intestinal Inflammation and Cancer One of the dangers of inflammatory bowel disease (IBD) is the risk of developing intestinal cancers, such as colorectal cancer. Results from a study suggest that fingolimod, a drug already approved to treat multiple sclerosis, could decrease or possibly stop the progression of IBD-related cancers. Using a mouse model, researchers showed that increased production of an enzyme causes intestinal cells to produce more molecules that trigger intestinal inflammation and cancer. Giving fingolimod to the mice decreased these activities. The scientists are planning more experiments to understand the link between inflammatory disease and intestinal cancers and to help test the multiple sclerosis drug as a potential new treatment for IBD-related cancers. This work also was supported by NIH’s National Cancer Institute; National Institute of Allergy and Infectious Diseases; National Heart, Lung, and Blood Institute; National Human Genome Research Institute; and National Institute of Neurological Disorders and Stroke. http://www.news.vcu.edu/news/Multiple_Sclerosis_Drug_May_One_Day_Treat_Colorectal_Cancer Wednesday 01/02/2013 - Itchy Wool Sweaters Explained Johns Hopkins researchers have uncovered strong evidence that mice have a specific set of nerve cells that signal itch but not pain, a finding that may settle a decades-long debate about these sensations, and, if confirmed in humans, help in developing treatments for chronic itch, including itch caused by life-saving medications. At the heart of their discovery is a type of sensory nerve cell whose endings receive information from the skin and relay it to other nerves in the spinal cord, which then coordinates a response to the stimulus. Published online Dec. 23 in Nature Neuroscience, a report on the research suggests that even when the itch-specific nerve cells receive stimuli that are normally pain-inducing, the message they send isn’t “That hurts!” but rather “That itches!” This work was supported by grants from the National Institute of Neurological Disorders and Stroke (NS054791, NS047399, NS014624, and NS070814), the National Institute of General Medical Sciences (GM087369) and the Howard Hughes Medical Institute. http://www.hopkinsmedicine.org/news/media/releases/itchy_wool_sweaters_explained