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On October 4, 2018, over 40 FDA Alumni Association members returned to the Jewel of India in Silver Spring for an informative discussion with Keith Flanagan, the Transition Lead for CDER's Policy Office of New Drugs (OND). As current and former FDA employees resisted multiple trips to the delicious buffet, Keith engaged in a substantive discussion about the OND Regulatory Modernization Program and the proposed structure of the OND Policy Office. We are thankful that Keith could take the time to meet with our members and it was wonderful to see so many familiar faces.
Using DIA China as a Launch Pad: FDAAA Discusses Collaboration Agenda with Chinese National Drug Administration Department of International Cooperation
By: Nancy Myers, Deb Autor, and Jinje Hu
On a windy Tuesday, May 22, an FDA Alumni Association leadership delegation enjoyed a warm meeting with the Chinese equivalent of FDA, previously called CFDA and described at the meeting as the National Drug Administration (NDA) or Chinese National Drug Administration (CNDA). We were all in Beijing for DIA China 2018.
The meeting was intended to advance the friendship between FDAAA and NDA and identify areas of potential collaboration to most effectively advance global public health. The high-level Chinese officials made their interest clear: they see value in engaging FDAAA directly to gain insight into lessons learned and gain forward-leaning insight in several targeted areas. FDAAA expressed its sincere interest in engaging with the Chinese NDA and sharing the experiences in rapidly-developing areas of US FDA regulation as China engages in its transformational regulatory reform efforts.
Chinese NDA Participants included:
- Mr. Yuan Lin, Director General, Department of International Cooperation
- Ms. Jiang Lu, Director of Division of Bilateral Cooperation, Department of International Cooperation
- Mr. Zhang Gaotong, Consultant, Division of Bilateral Cooperation, Department of International Cooperation
- Ms. Liu Yuan, Principal Staff Member, Division of Bilateral Cooperation, Department of International Cooperation
The FDAAA delegation included:
- Deb Autor, FDAAA Board Member and Chair, Nominations Committee
- Jinjie Hu, Chair, FDAAA International Network
- Nancy Bradish Myers, FDAAA Board Chair
Director General Yuan opened the meeting, voicing appreciation for the FDAAA visit and our work. He walked the group through the evolution of his agency over the last few decades from SDA to SFDA to CFDA to the newly established, likely-to-be-called NDA (or possibly CNDA). He shared that the reformed NDA will focus on registration, supervision, and management of drugs, devices, and cosmetics.
Given that it is the prerogative of the National People's Congress to reevaluate the NDA every five years, frequent reforms will likely continue. The biggest difference with this most recent reorganization is that food safety is now shifted to the superior organization, SAMR (State Administration for Market Regulation), which he described as a minister-level agency, the equivalent to the level of our DHHS in the US.
Reform of the agency is now underway; it will occur in two phases, and is intended to strengthen drug regulation and adapt to the rapid development of innovation and the market economy. The ultimate goal for the leadership of China's NDA is to " provide better products for our people and improve efficiency of review and approval and quality of product."
Phase 1 began in August 2015 with the issuing of a directive No. 44, issued by State Council of China; this directive is intended to improve the quality of review and approval and resolve the backlog, in addition to improving the quality of generics, encouraging innovation, and improving transparency of review and approval.
After over two years of reform, NDA can point to what it considers substantial results. The CDE staff totaled less than 200 when Phase 1 began; it is now over 800. The registration application backlog, which was over 22,000 in 2015, is now less than 4,000. Mr. Yung talked about how the speed of review and approval has been increased dramatically. He believes the philosophy of regulators in China has changed and thus has sent a clear signal to industry that the agency is facilitating innovation.
Under Phase 2, which began in August of 2017, the General Office of Central Committee and State Council jointly issued a directive on review and approval and innovation in order to encourage innovation of drugs and devices to better serve public health.
Mr. Yuan pointed out several priorities for reform:
- The first reform focus is to encourage better new drugs and devices - not just domesticly-made products, but also imported ones.
- China is putting in place policies to advance innovation within China and to accelerate the approval of innovative new drugs from outside China to meet unmet medical needs.
- The second priority for China will be to improve the accessibility of medical products. Director General Yuan recognized the value of lower cost drugs and referred to FDA Commissioner Scott Gottlieb recent statements on the need to lower drug prices.
- Though China has a big focus on supporting innovation, he indicated that the country will need to balance access to high priced, innovative drugs with use of high quality and efficacious generics that are the equivalent of brand name drugs.
- He discussed the need and steps China is taking to improve the quality of generic drugs as it works to ensure that generic drugs are the same as RLD.
This reform will likely borrow from key learnings from the US FDA, such as: creation of the Orange book, IND review (in particular, the multi-disciplinary subject expert team review model for clinical trial applications), and establishing patent protection and patent linkage systems.
Part of this reform agenda has been to bring the Chinese system more in-line with international standards. For example, China joined a number of important international organizations like the ICH, ICMRA (International Coalition of Medicines Regulatory Authorities}, and IMDRF (International Medical Device Regulators Forum). The participants in the meeting pointed to the fact that China chaired the IMDRF meeting in Shanghai in March this year.
Recently China also applied to be ICH management committee member, hoping to make an active contribution to ICH while learning from ICH and work to harmonize its standards with those of other countries.
We took the opportunity to highlight FDAAA's recent strategic planning efforts and its vision for assisting regulators globally. We shared examples of innovative, supportive collaborations our volunteer have initiated supporting regulators like our FDA Alumni Advisor Program established initially with FDA's Office of Regulatory Affairs. We congratulated NDA on its vision for a modernized medical product review process which is focused on safety, efficacy and innovation. We also recognized NDA for recently being elected to be a Management Committee member of ICH at the recent June 7th, 2018 ICH Annual meeting in Japan.
During the meeting, NDA and FDAAA agreed that there were a few areas of mutual interest and possible meaningful cooperation that should be considered in terms of sharing expertise and experience. These areas are:
- Gene therapy
- Digital medicines
- Treatment of infectious diseases
- Generics, and
- Combination Products
Our next step, from the FDAAA perspective, will be to ask the FDAAA International Network to meet and propose to the Board an approach for the NDA and to identify the most impactful synergies where we might collaborate with NDA. Although our resources are finite, this is a great opportunity to help leverage our expertise for the benefit of global health. We will be seeking FDAAA volunteers to staff this initiative and share their expertise.
Director General Yuan and his NDA colleagues indicated that they look forward to our feedback and assigned a specific point person with whom we should work.
We ended the meeting agreeing that NDA and FDAAA share the same goal - to protect and promote the public health. We acknowledged the value of vigorously exploring how we might work together to accomplish this important global objective.
On June 12, 2018, the FDA Alumni Association hosted its 9th Annual Spring Fling in the Great Room at FDA Headquarters in White Oak, MD. Over 70 current and former FDA staff attended the event and enjoyed delicious BBQ catered by Red Hot & Blue.
This year's Spring Fling was especially meaningful as the FDAAA honored Jim Benson, a founding member for the Board of FDAAA and former Acting Commissioner, Deputy Commissioner and Director of the Center for Devices and Radiological Health (CDRH). Joe Levitt, Former Chair of FDAAA, presented Jim's wife, Cynthia Benson, with a plaque to commemorate the naming of the scholarship fund for students enrolled in the Temple University School of Pharmacy's Quality Assurance/Regulatory Affairs graduate program in honor of Jim. CDRH's current Director, Dr. Jeff Shuren, also spoke about Jim's service, noting his dedication to CDRH and to FDA, and his commitment to promoting public health.
Dr. Gottlieb informally addressed the group, highlighting FDA's accomplishments during his first year as Commissioner as well as the Agency's top public health priorities. The Commissioner took questions from the group on a range of topics, including plans for the CDER/OND reorganization, the 2019 budget request, how the Agency can help manage the ongoing opioid epidemic, and how technology has allowed the Agency to communicate more effectively to consumers.
We are thankful to everyone who joined the Spring Fling and look forward to continuing the tradition!
FDAAA has decided to name its scholarship fund for students enrolled in the Temple University School of Pharmacy's Quality Assurance/Regulatory Affairs graduate program in honor of Jim Benson, a founding member of the Board of FDAAA and FDA's former Acting/Deputy Commissioner and CDRH Director. Jim recently passed away.
The FDAAA Centennial Scholarship Award was created in 2006 in honor of FDA's centennial. The endowment created the first scholarship in the school's QA/RA program.
At the time, FDAAA said it established the endowment not only to commemorate the 100th anniversary of the Pure Food and Drugs Act but also to encourage academic training in regulatory and quality issues. FDAAA selected Temple after reviewing graduate programs of schools nationwide.
The fund will now be known as the James S. Benson FDAAA/FDA Centennial Scholarship Fund.
In 2006 donations to the fund came from pharmaceutical trade associations, including the PhRMA Foundation, drug firms, and FDAAA members.
Nancy Myers, chair of FDAAA. Urged current members who want to honor Jim Benson to donate to the fund.
"Jim was a highly regarded and admired member of the FDA and FDAAA communities and I can think of no better way to honor him than to name this program in his memory and for current FDAAA members to contribute to his memory, "she said. "The FDAAA Executive Committee believed that adding Jim's name to the Temple award is a fitting recognition of his contributions to the FDA community and to FDAAAA."
Joe Levitt, former chair of FDAAA, said naming of the scholarship fund for Jim was especially appropriate. "Jim was always a champion of education in his many years at the FDA. He began his career in the education division of radiological health. Plus, Jim was a driving force in the creation of the FDAAA/Temple Scholarship Fund by spearheading the fundraising efforts that created the initial endowment of the program."
Jim's wife Cynthia has been invited to attend the June 12 Spring Fling and to accept the honor in Jim's memory. Cynthia is an FDA Alumna, having worked for several decades in CDRH.
Christopher Van Vessem, Assistant Dean For Development and Alumni Relations, Temple University School of Pharmacy, remarked, "I am sorry to hear that Jim passed away. What a fitting gesture to make on Jim's behalf."
Temple University School of Pharmacy is a pioneer in providing advanced academic coursework in quality assurance and regulatory affairs, which refer to the quality practices and regulations governing the pharmaceutical, medical device, biotechnology, healthcare and consumer products, and related industries. The school was the first to create a masterâs program in QA in 1968. In the 1990s, the school created the first academic certificate programs in drug development, clinical trial management, and medical device regulation.
Donations designated for the James S. Benson / FDA Centennial Scholarship Fund may be sent to:
Christopher Van Vessem
Director of Development
School of Pharmacy
3307 North Broad Street
Philadelphia, PA 19140
The Food and Drug Administration Alumni Association (FDAAA), whose members consist of FDA alumni and current employees, has announced its leadership for 2018-2019.
The officers of the Association will be (asterisks mark new positions):
- Chair: Nancy Myers
- President: Ed Steele
- * Vice President: Allen Sayler
- Treasurer: Bryan Coleman
- *Vice Chair: Robert Brackett
- *Secretary: Marie Urban
- General Counsel: Jessica OâConnell
The members of the FDAAA Board will be:
- Deb Autor
- Dennis Baker
- Lisa Barclay
- Robert Brackett
- Cathy Carnevale
- David Chesney
- Anne Marie Finley
- Nancy Myers
- Fredda Shere-Valenti
- Ed Steele
- Marie Urban
- Kathryn Zoon
The leadership was announced at the annual Spring Fling that FDAAA holds annually with the FDA to celebrate the collaboration between FDA and the Association.
Nancy Myers, re-elected as FDAAA chair, said: "The many dedicated leaders of this Association are committed to representing the former and current employees of FDA and to developing joint programs that advance the Agency's mission. We again look forward to an active and productive year."
FDAAA 2017 Annual Report with Activities and Pictures for the past year
On April 20, 2018, over 40 FDA Alumni Association members spent a sunny Friday afternoon engaged in an informative discussion at the Jewel of India in Silver Spring with Dr. Jeffrey Shuren, the Director of the Center for Devices and Radiological Health (CDRH). As current and former employees enjoyed unlimited samosas and a wonderful buffet, Dr. Shuren discussed a wide array of topics, from the recently released Medical Device Safety Action Plan, digital health regulation, and his vision for the Center's new organizational structure. We are thankful that Dr. Shuren could take the time to engage in a substantive dialogue with our members.
For almost a decade FDAAA has sponsored an FDA history educational session for the FDA Fellows, a group of young professionals working at the agency, many of whom will become permanent employees. This year the panel was, from left, FDAAA members Wayne Pines, Nancy Myers, Andrea Chamblee, Brian Harvey and Coleen Klasmeier. Some of the Fellows actually joined FDAAA after the half day session, which also included a lecture from FDA historian Suzanne Junod and a presentation on FDA's budget by Steven Grossman of the Alliance for a Stronger FDA.
On January 19, 2018, a glimmer of spring was in the air as a crowd of over 40 FDA Alumni Association members gathered in the sunny Terrace Dining Room at Mrs. K's Tollhouse restaurant in Silver Spring for an informative lunch with Dr. Peter Marks, the Director of the Center for Biologics Evaluation and Research (CBER). While enjoying a delicious buffet (that finished with amazing cookies), current and former employees from across the Agency enjoyed the informal setting in which Dr. Marks discussed a wide array of topics, from recent FDA approvals of CAR-T cell therapies, innovative new developments in the stem cell arena, and a preview of CBER priorities for 2018. We are grateful that Dr. Marks could take the time to spend with our members. Please stay tuned for future FDAAA events!
FDAAA held its second annual West Coast Networking Event in early January during the 36th Annual J.P. Morgan Healthcare Conference in San Francisco. More than 30 FDA alumni and guests - triple the attendees from the previous year - gathered at the popular Hotel Zetta to reconnect with old colleagues and make new contacts. We look forward to having an equally successful event next year!
Recent FDAAA Events
- FDAAA Fall Luncheon Featuring Keith Flanagan, J.D. (10/4/18)
- China FDA meets with FDAAA (6/20/18)
- Spring Fling 2018 (6/20/18)
- FDAAA Names Temple Scholarship in Memory of Jim Benson (6/13/18)
- FDAAA Announces Officers and Board Members (6/12/18)
- FDAAA Spring Luncheon Featuring Jeffrey Shuren, M.D., J.D. (4/24/18)
- Report from President (3/1/18)
- FDAAA Sponsors FDA Fellows Session (2/10/18)
- West Coast Networking Event (2/1/18)
- FDAAA's Winter Luncheon Featuring Peter Marks, M.D., Ph.D. (1/20/18)
- A Winter Celebration (12/14/17)
- Eastern Shore Informal Gathering (7/23/17)
- FDAAA Meets and Greets Current Employees (6/26/17)
- Another Successful Spring Fling (6/22/17)
- Dr. Scott Gottlieb is New FDA Commissioner (5/12/17)
- Dr. Hamburg Receives FDAAA's Wiley Award (5/11/17)
- FDAAA Briefs FDA Fellows Class on FDA History, Perspective (1/24/17)
- FDAAA Luncheon on West Coast, A Huge Success (1/18/17)
- FDA and FDAAA Refresh MOU after 13 years (12/13/16)
- FDAAA's Hail to the Chief Counsels and Their Deputies a Resounding Success (12/12/16)
- Hail to the Chief Counsels (12/09/16)
- FDAAA Midwest Inaugural Luncheon Held in Chicago (12/09/16)
- In Memorium: Ekopimo Ibia, M.D., M.P.H., MRCPCH, FWACP (Peds), FRCP (06/27/16)
- Spring Fling! (05/23/16)
- FDAAA Honors Three Leaders (05/23/16)
- FDAAA Members Are Updated on Combination Products (04/12/16)
- FDA Alumni Advisor Program a Big Success (03/25/16)
- FDAAA Contributes to WHO Guideline on Good Regulatory Review of Practices (02/20/16)
- FDAAA Conducts Seminar for FDA Fellows (01/09/16)
- Reception for Chiefs of Staff (12/10/15)
- Luncheon November 6, 2015 (11/06/15)
- FDAAA International Network visits with CFDA Officials and BioBAY Entrepreneurs (08/03/15)
- Dr. Florence Houn Receives DIA China Excellence in Service Award (08/03/15)
- FDAAA International Network Expands Footprint at 2015 DIA China Annual Conference in Shanghai China (08/03/15)
- FDAAA International Network hosts an "FDAAA and Friends Night" event in Shanghai (08/03/15)
- FDAAA International Network Featured at 51st Annual DIA Meeting (08/01/15)
- Andrew Bonanno Receives FDA Distinguished Alumni Award (06/29/15)
- Michael Taylor Receives FDAAA Wiley Award (06/28/15)
- FDAAA Launches New Year at Annual Meeting (04/20/15)
- FDAAA Elects New Board Members, Names Officers (04/20/15)
- FDAAA Luncheon with FDA CDER Center Director, Janet Woodcock, MD, April 2, 2015 (04/10/15)
- NEW FDA Alumni Mentor Program to Begin in the Fall! (8/31/17)
- FDA Celebrates 40th Anniversary of Medical Devices Amendments (06/21/16)
- FDA Seeking "Objective" Reviewers for Grant Funding (04/19/16)
- Vacancy Announcements for Key Alumni Association Positions (12/18/15)
- FDA and FDAAA to Collaborate on Pilot Alumni Advisor Program (04/17/15)
- Opportunity: RAPS Seeks Regulatory Experts (03/10/15)
- 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)