FDAAA serves FDA alumni by providing communications, holding functions, listing opportunities, and much more. Serving those who have served also takes the form of helping those who still are serving, the current staff at FDA.
Feb 26th Lunch and Learn
- Date: February 26, 2015
- Time: 11:30 AM, speaker to begin at noon
- Event Type: Lunch and Learn, Brown Bag (bring your own lunch; drinks and dessert will be provided)
- Speaker: Ed Cox, Director of the Office of Antimicrobial Products in CDER
- Topic: Perspectives on FDA Activities related to Ebola
- Location: FDA White Oak Campus, Building 31, Great Room (enter through Main entrance of Building 1; guards will direct you to the Great Room in Building 31)
- Address: 10903 New Hampshire Avenue, Silver Spring, MD 20993
- Cost: $10
- RSVP: Jayne Ware at Jayne.Ware@Merck.com
FDAAA Praises Hamburg for Her Dedication To FDA's Mission and Looks Forward to Working with Dr. Stephen Ostroff Who Will Serve as Acting Commissioner
This morning, Dr. Margaret Hamburg announced she will be leaving her post as Commissioner at the end of March after serving in this post for over five years.
As a strong supporter of the FDA Alumni Association (FDAAA) we will be sorry to see her move on but, we look forward to her joining us more often in the future in her alumni status. Chairman of the FDAAA Board, Nancy Myers said, "On behalf of the thousands of alumni that have dedicated their careers in support of the mission of the Agency, we praise Dr. Hamburg's dedication and hard work in protecting the health of the US consumer. Her accomplishments have been many and she will be missed."
FDA's Chief Scientist, Dr. Stephen Ostroff will serve as the Acting Commissioner until the position can be filled on a permanent basis. The Alumni Association looks forward to working with Dr. Ostroff in continuing the cooperative relation that exists between the FDA and the Alumni Association.
A Message from the Commissioner
Dear FDA Colleagues:
It has been a privilege to serve as your FDA Commissioner for almost six years. So it is with very mixed emotions that I write today to inform you that I plan to step down as FDA Commissioner at the end of March 2015. As you can imagine, this decision was not easy. My tenure leading this Agency has been the most rewarding of my career, and that is due in no small part to all of you - the dedicated and hard-working people that make up the heart of this Agency. While there is still work ahead (and there always will be), I know that I am leaving the agency well-positioned to fulfill its responsibilities to the American public with great success.
I feel so fortunate to have worked at an organization as remarkable and productive as the FDA. The expertise, dedication and integrity of our people and the unique nature and scope of FDA's role make this Agency truly special. Every day, FDA employees around the world recommit themselves to the Agency's work, to quality science, to facilitating innovation, and to the protection of public health. And because of your dedication and your service, we have been able to achieve so many significant milestones over the past years.
From creating a modernized food safety system that will reduce foodborne illness; advancing biomedical innovation by approving novel medical products in cutting-edge areas; and responding aggressively to the need to secure the safety of a globalized food and medical product supply chain, to taking critical steps to reduce the death and disease caused by tobacco, we have accomplished a tremendous amount in the last six years. We can honestly say that our collective efforts have improved the health, safety and quality of life of the American people.
At the heart of all of these accomplishments is a strong commitment to science as the foundation of our regulatory decision-making and of our integrity as an Agency. And while there are far too many significant actions, events, and initiatives to count, there are some highlights of the past years that I particularly want to mention.
In the foods area, we have taken critical actions that will improve the safety of the food Americans consume for years to come. These include science-based standards developed to create a food safety system focused on preventing foodborne illness before it occurs, rather than responding after the fact. We have taken several significant steps to help Americans make more informed and healthful food choices. These include working to reduce transfats in processed foods; more clearly defining when baked goods, pastas and other foods can be labeled "gluten free;" updating the iconic Nutrition Facts label; and, most recently, finalizing the rules to make calorie information available on chain restaurant menus and vending machines.
We have also made great strides in advancing the safety and effectiveness of medical products. Some of these important steps include new oversight of human drug compounding and provisions to help secure the drug supply chain so that we can better help protect consumers from the dangers of counterfeit, stolen, contaminated, or otherwise harmful drugs. We are continuing to increase the speed and efficiency of medical product reviews. We just had another strong year for novel drug approvals, with most of these drugs being approved on or before their PDUFA goal dates and most being made available to patients in the United States before they were available to patients in Europe and other parts of the world. We launched a powerful new tool to accelerate the development and review of "breakthrough therapies," allowing FDA to expedite development of a drug or biologic to help patients with serious or life-threatening diseases. In fact, almost half of the novel new drugs approved in 2014 received expedited review with a combination of breakthrough designation, priority review and/or fast track status. These included drugs for rare types of cancer, hepatitis C, type-2 diabetes and idiopathic pulmonary fibrosis, as well as a number of groundbreaking vaccines. We have also established a regulatory pathway for biosimilar biological products that will create more options for patients.
On the medical device side, the average number of days it takes for pre-market review of a new medical device has been reduced by about one-third since 2010. The percentage of pre-market approval (PMA) device applications that we approve annually has increased since then, after steadily decreasing each year since 2004. We also published the Unique Device Identification (UDI) final rule that is intended to improve the tracking and safety of medical devices. And we proposed a risk-based framework for laboratory developed tests (LDTs) to help ensure patients and providers have access to safe, accurate and reliable tests, while continuing to promote innovation of diagnostic tests to help guide treatment decisions.
We have ushered in the era of personalized medicine across all of our medical product centers. For example, many cancer drugs are increasingly used with companion diagnostic tests that can help determine whether a patient will respond to the drug based on the genetic characteristics of the patient's tumor. A growing percentage of our recent approvals have involved targeted therapies, offering many patients more effective response profiles and/or reduced likelihood of side effects.
We made significant progress in implementing both the letter and spirit of the Family Smoking Prevention and Tobacco Control Act. Our tobacco compliance and enforcement program has entered into agreements with numerous state and local authorities to enforce the ban on the sale of tobacco products to children and teens; conducted close to 240,000 inspections; written more than 12,100 warning letters to retailers; proposed the extremely important foundational "deeming" rule; and broken new ground for FDA with the launch of the Agency's first public education campaigns to prevent and reduce tobacco use among our nation's youth.
As Commissioner, my goal has been to shape and support an FDA that is well-equipped to meet the challenges posed by scientific innovation, globalization, the increasing breadth and complexity of the products that we regulate, and our new expanding legal authorities. I have worked hard to advocate for FDA and our unique and essential mission, including building new partnerships to support our work. The Agency has received numerous votes of confidence with the bi-partisan enactment of a series of landmark bills extending our authority in the areas of tobacco, food safety and medical products. In addition, we have achieved a dramatic increase in our budget, from some $2.7 billion in FY2009 to almost $4.5 billion in FY2015.
As hard as it is to leave this Agency, I am confident that the leadership team that we have in place will enable FDA to capitalize on, and improve upon, the significant advances we've made over the last few years. Many of these leaders have been with the FDA throughout my tenure, and I am proud to say that we've recently made some wonderful new additions.
And with respect to the agency's senior leadership team, I am pleased that Dr. Stephen Ostroff has agreed to serve as Acting Commissioner when I step down. Since joining the Agency in 2013, and most recently serving as FDA's Chief Scientist, Dr. Ostroff has successfully overseen numerous significant initiatives, while helping to ensure that scientific rigor, excellence and innovation are infused across the Agency. I have every confidence that he will take on this new role with the same energy, dedication and care.
I want to extend my deepest gratitude to each and every one of you for your service and for making FDA an agency that is not only an exciting and rewarding place to work, but also a place of remarkably meaningful achievement and impact on the health and well-being of Americans.
Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
About 100 members of the FDAAA gathered on Tuesday November 18 in downtown Washington to recognize and honor former and current directors of FDA centers. Fourteen center directors attended.
Nancy Myers, FDAAA chairperson, who MCed the event, noted the important role that center directors play at FDA, by providing leadership and direction for programs including product approvals and compliance. Ed Steele, FDAAA president read the following remarks from Commissioner Margaret Hamburg who was unable to attend in person:
I am sorry that I could not attend the tribute to FDA's Center directors past and present, due to my long planned trip to China. However, I want to pass along my personal appreciation for the contribution our Center directors have made and continue to make to our nation's health and well-being. Before becoming FDA's Commissioner, I had a broad, but incomplete appreciation – like that of many Americans – for FDA's role in what is often called out consumer product "safety net." My five-plus years at FDA have given me a much fuller understanding of how remarkable FDA is as an institution that protects all of us every single day. And the range of roles and responsibilities that the Center directors have taken on over the years is nothing short of extraordinary. While the FDA is comprised of thousands of truly dedicated people, it is the Center Directors that provide the critical leadership their employees need to realize those exceptional achievements. You are all singular leaders and my respect for your accomplishments is boundless. You are genuinely awe inspiring. Thank you so much for all you have done year after year and for being – in so many ways – the heart and soul of the Food and Drug Administration.
The gathering was held at FoxKiser, a law firm in downtown DC. Sponsors of the event included FoxKiser, Biogen Idec, Greenleaf Health, Hogan Lovells, Keller & Heckman, King and Spalding, Alston & Byrd, Catalyst Healthcare Consulting and, Biotech Policy Group.
The event is part of a series sponsored by the FDAAA to recognize leaders at the FDA and to provide an opportunity for FDAAA members to gather in an informal setting with friends and former colleagues.
Recent FDAAA Events
- FDAAA Holds End of Year Reception as a "Tribute to Center Directors – Past and Present" (12/2/14)
- September 14 FDAAA Luncheon with FDA CDER Deputy Center Director for Science Operations, Richard A. Moscicki, MD (10/27/14)
- FDAAA Sponsors Session on Clinical Research Enterprise in Africa, Asia, and South American at 50th US DIA Annual Meeting (07/16/14)
- Fifth Annual FDAAA Spring Fling - May 27, 2014 (06/15/14)
- Drs. Florence Houn and Zili Li, co-chairs of FDAAA's International Network received FDA's Distinguished Alumni Award at FDA's June 6th Award Ceremony (06/15/14)
- Update on FDAAA International Network Co-Chair Activities at DIA China, Shanghai China (05/22/14)
- FDAAA International Network Conducts GxP Training at DIA China, Shanghai (05/22/14)
- FDAAA International Network (FDAAA IN) Visits with China FDA Officials (05/22/14)
- The FDAAA's Annual Meeting and Board Meeting (05/05/14)
- Dr. Robert Temple Receives FDAAA's 2014 Harvey W. Wiley Award (05/04/14)
- FDAAA's 2013 Annual Report Released in Advance of April 22, 2014 Annual Meeting (03/20/14)
- FDAAA Luncheon with FDA Associate Commissioner for Regulatory Affairs Melinda Plaisier, February 6, 2014 (02/12/14)
- FDAAA Luncheon with FDA Chief of Staff Lisa Barclay, January 10, 2014 (01/22/14)
- FDAAA Praises Hamburg for Her Dedication To FDA's Mission and Looks Forward to Working with Dr. Stephen Ostroff Who Will Serve as Acting Commissioner (02/05/15)
- FDAAA Announces New Treasurer and Chairs for New Member Recruitment Committee (08/10/14)
- Dr. Beverly Corey, FDA's Senior Regional Advisor for Sub-Saharan Africa has passed away (08/09/14)
- FDAAA joins FDA in recognizing the 100th birthday of one of the Agency's most celebrated alumnus (07/29/14)
- Passing of Ronald (Ron) Ottes (05/22/14)
- Dr. Steven Solomon Appointed As DACRA (04/15/14)
- John Roth, Office of Criminal Investigations Director Leaves FDA, Phil Walsky becomes Acting OCI Director (03/21/14)
- CDRH Holding Memorial Seminar on February 26 (02/18/14)
- FDA Chief Scientist Dr. Jesse Goodman Leaves FDA, Dr. Stephen Ostroff Becomes Acting Chief Scientist (02/12/14)
- Special Advisor to Dr. Hamburg Dr. Murray Lumpkin Retires (02/12/14)
- Associate Commissioner for Foods and Veterinary Medicine, Linda Tollefson to Retire (01/31/14)
- Dr. Hamburg announced the appointment of Howard Sklamberg as Deputy Commissioner for Global Regulatory Operations and Policy, effective January 13, 2014. (01/23/14)
This individual page is maintained by Linda Tukenmez