Recipient of the Frances O. Kelsey Award for Courage and Excellence in Protecting the Public Health
The FDAAA’s New Website (Still at www.fdaaa.org )
We are so pleased to unveil our new website. Not only is this modernized website more attractive and easier to follow, it has great new features such as members-only access to a growing collection of FDA- related information, a skills inventory, and the ability to chat with other members behind a secure firewall.
This website will take us into a new era when FDAAA does even more to support your ongoing enrichment, connection to each other and to FDA, and your ability to locate resources, colleagues, friends, and experts.
The FDA Alumni Association is the official global network of former and current FDA employees, connecting and supporting alumni, the Agency, and the public health community. Please be active in FDAAA and help us to make a difference. In speaking about FDAAA, then-Commissioner Ned Sharpless recently reminded us of a key quote from Margaret Mead: “Never doubt that a small group of thoughtful, committed citizens can change the world; indeed, it’s the only thing that ever has.”
Members are encouraged to visit the Newsletter - Updates for the latest edition of the Newsletter, July 2020.
Deb Autor, Chair Board of Directors
FDA ALUMNI ASSOCIATION
SAVE THE DATE…for our first FDA Alumni Association VIRTUAL Speaker Series Event!
We are thrilled to have Dr. Luciana Borio (former Director for Medical and Biodefense Preparedness Policy for the White House National Security Council and former Acting Chief Scientist and Assistant Commissioner for Counterterrorism and Emerging Threats at FDA ) as our guest speaker on COVID-19 issues.
This virtual event will be held via Zoom on Wednesday, August 5 at 2:00 pm Eastern.
Please be on the lookout for the official invitation to this event—coming soon!
Lisa Barclay, Chair Activities Committee
FDAAA F. Alan Andersen, PhD Newsletter – Update July, 2020
F. Alan Andersen, PhD FDAAA Past President
Re-Naming the FDAAA Newsletter - Update
Following is a bit about Alan and some of his many contributions to the FDAAA.
F. ALAN ANDERSEN, PhD is a Senior Consultant at the EAS Consulting Group, LLC. Dr. Andersen received his BS from Muhlenberg College and his MS and PhD from Penn State. In 2013, he retired as the Director of the Cosmetic Ingredient Review, where he led that group’s mission to thoroughly review and assess the safety of ingredients used in cosmetics in an open, unbiased, and expert manner. Prior to joining CIR in 1993, Dr. Andersen was Acting Director, Office of Device Evaluation, and Director, Office of Science and Technology, at the Food and Drug Administration’s Center for Devices and Radiological Health. In his 22 years at FDA, he led efforts to deal with such diverse issues as tampons and toxic shock syndrome, sunlamp safety, laser safety and the evaluation of silicone breast implants. He has received the Public Health Service Superior Service Award, the FDA Award of Merit, Employees EEO Recognition Award, and the Sigma Xi Award of Recognition. He has received the FDA’s Distinguished Alumni Award and was made a Penn State Alumni Fellow in 2011. More recently, he received the Food and Drug Law Institute Distinguished Service and Leadership Award and the FDA Alumni Association (FDAAA) Founders Award. He is a charter member of the FDAAA. At the FDAAA, he has served as Chair of the Member Services Committee, Treasurer, Board of Directors member, and President. He currently serves on the Communications Committee.
It is fitting that the association recognize Alan’s contributions by renaming the Newsletter – Updates to recognize his support over many years. Alan’s hard work is a testament to his support of the association and it is a pleasure to honor him this way.
Alan, thank you for all you have done, “Serving Those Who Have Served”. This is a well-deserved recognition.
Deb Autor, Chair BoD, the FDAAA Executive Committee, and Richard Baldwin, Chair Communications Committee
Swan Song
This will be the last FDAAA Update that I will pen, or whatever the correct verb is to encompass all the computer stuff that goes with putting together these newsletters. I have been doing the newsletter for a lot of years now (15+) and it is time for some new blood.
Fredda Shere-Valenti
and Barbara Cassens will take over the job. Fredda brings her long experience with the FDAAA to the table and you could say without fear of contradiction that she knows how to tell it like it is! And, in Barbara Cassens, we will have an associate member working on the information that the FDAAA is providing to its members. As the expression goes, what is not to like?
Fredda Shere-Valenti was in the ORA organization for 25 years. Fredda held various positions supporting in the New York District Office and the New York Regional Laboratory. In ORA HQ Fredda served in the Office of Regional Operations, developing field compliance programs with Centers and assisting the other divisions' activities. In 1987, she transferred to the Division of Field Science, publishing the Laboratory Information Bulletin (LIB), maintaining the latex products database, and developing the microbiological chapter for the Laboratory Procedures Manual. In 1989 Fredda rose to a consumer safety officer in the Division of Import Operations Policy. Fredda transferred in 2002 to CVM and worked with BIMO general programs, eventually retiring from FDA.
Barbara Cassens is the Director for the Office of Partnerships (OP). In her role as the Director of OP, she is responsible for the oversight, strategic planning, collaboration and integration with our federal, state, and local, partners, for manufactured human and animal food safety standards.
Richard Baldwin, Chair of the Communications Committee, will serve as a backup to Fredda and Barbara, should the need arise.
When you have information for the Newsletter – Updates please send them to [email protected] for forwarding to Fredda & Barbara. In the near future we will have a separate [email protected] e-mail, specifically to you to submit send items for the Newsletter.
I want all of you to know that I have appreciated the opportunity to be involved with the FDAAA. I knew the folks working in the CDRH family from the time when I worked there. I got to know others across the rest of the Agency working on peer-review promotions for regulatory scientists and still more when I headed the independent Cosmetic Ingredient Review. But it wasn’t until my FDAAA involvement that I had the chance to get to know and interact with individuals who had spent their careers at FDA working in areas totally foreign to me – and that was and is truly wonderful, IMHO.
I encourage each of you to take advantage of the opportunity for every face-to-face interaction (once social distancing practices are lifted or relaxed…) that FDAAA is able to provide, especially those from parts of FDA with which you were not involved, and keep reading the FDAAA Updates-Newsletter if you cannot be there in person. I will continue to be involved with the Communications Committee and help as I can as the FDAAA continues to move forward. Feel free to send us anything you think newsworthy at [email protected] and we will get it to the membership!
New Members
Associate members
Welcome to new FDAAA associate members Kimberly Bailey, Mark Richard Baldwin, Steven Herbert Chasin, PhD, Jianxiong (George) Chu
Kimberly has been with ORA since 1992 and is currently doing administrative management in Detroit.
Mark has been with CDRH since 1995 and works as an IT specialist. Steven has been at CDRH since 1991 and currently serves as Associate Director for Professional Development in the Office of Regulatory Programs in the Office of Product Evaluation and Quality.
George has been with FDA since 2003 and is a supervisory mathematical statistician in CDRH/Office of Product Evaluation and Quality/Office of Clinical Evidence and Analysis/Division of Clinical Evidence and Analysis 2 (Biostatistics). He serves as Assistant Division Director Biostatistics Team 7.
Alumni members
Welcome to new FDAAA alumni members Tanvir K. Bell, MD, Marsha B. Henderson, Gary G. Lloyd and Jamie C. Wilkins, PharmD.
Tanvir worked as a medical officer in CDER for just over 4 years and she is now at Astra Zeneca serving as Global Clinical Programme Lead, Respiratory and Immunology, Research and Development. Prior to joining FDA, she was spent almost 10 years as an Associate Professor of Medicine at the University of Texas Health Science Center at Houston (UTHealth).
Marsha served as FDA's Assistant Commissioner for Women's Health in the Office of the Commissioner until her retirement in 2019. She has been profiled as a nationally recognized innovative leader and change agent for the health of women and their families.
Gary worked in ORA from 1962 to 1994 in the Newark District as a compliance officer. Just think of the stories he could tell about field work in FDA during those 32 years! Thank you for your service, Gary.
Jamie worked at CDER in the Office of Surveillance and Epidemiology for over 9 years. When she left FDA, she was the Deputy Director in the Division of Risk Management. That Division develops and oversees REMS programs for approved drug and biologic products. She is now Director, Risk Management Products Lead in the Center of Excellence for Risk Management -Worldwide Safety at Pfizer.
Opportunites
1. The Embassy of Denmark is seeking former FDA regulatory experts.
The Danish Embassy, located in Washington, DC, regularly receives requests from companies in Denmark requiring regulatory advice that fall within the scope and authority of the FDA and its centers. In response, the Embassy provides a list of regulatory experts to companies for their own review and decision. The Embassy is currently in the process of updating a list of regulatory experts who have scientific, medical and legal expertise covering drugs (Rx & OTC), biologics, medical devices/digital health, cosmetics, and dietary supplements. Focus in areas such as; emerging technologies, regulatory pathways for development, product registration, and compliance is desired. Regulatory experience in dealing with technologies/products requiring FTC, FCC and EPA coordination is also of interest.
For more information contact Elizabeth Dempsey Becker, Counselor & Senior Commercial Advisor, Danish Embassy at [email protected]
2. EAS Consulting Group
3. USP
The USP has a couple of job opportunities.
- Senior Director, Growth Programs (Excipients, Foods, Dietary Supplements and Herbal Medicines). This is a key leadership position in the Documentary Standards and Compendial Policy Department, responsible for developing and executing the operational strategy for three Program Units with direct responsibility over the development and execution of the scientific strategy for those areas, including documentary standards, new monograph development and revision, monograph modernization, and the USP-NF. See more at http://www.fdaaa.org/currernt_job/fdaaa-20-044.php
- Senior Manager, Personalized Medicines. This position will lead a small team of Scientific Liaisons (SLs) specialized in Personalized Medicines and will report to the Senior Director Healthcare Quality and Safety (HQS). This role serves as the leader in managing the Personalized Medicines efforts of the Compounding Expert Committee and other associated activities. See more at http://www.fdaaa.org/currernt_job/fdaaa-20-043.php
FDA Memories
Remember FOB-8? Here is a link to a story that will bring back memories to lots and lots of FDAers: https://www.aoc.gov/blog/then-now-oneill-house-office-building?fbclid=IwAR0A70ncMMdHQybTAa3- V5k-OsgMb0dLuF00dMLLRcZs0kMD0tm6LCYlFLk
I remember the Commissioner’s Conference Room fondly with that huge map. That is where all of us non-CFSAN folks would rally before going over to HHS or the Hill to do a dog and pony show.
Virtual Learning
As we all strive to cope with working in this so-called “new normal,” it is nice to see that the FDLI has put an emphasis on virtual learning that may be of use.
As FDLI says “Take advantage of FDLI’s Virtual Learning Platform to invest in yourself. Continue your education in convenience by attending live and on-demand educational programs, or make the most of your downtime by reading through resources available in the learning library.”
Check it out at https://www.fdli.org/virtual- learning/?mkt_tok=eyJpIjoiTkRFMk1HVm1abU0zTVdVeSIsInQiOiJRVU1DXC9qOGg1ekN2XC9YZHp4Zlox MVNJcnBiWSswRGpuVkY1Skc3WlJhUkx6Sm9ydWxFaGlHK0hcL3o1cFlMYTl5MzVGeFk0SXFyS3U1TURlbH hvWHhtU1N0WVUzRDFsb3h2a2I4clVlSnp0bGZqZmtHYkZoMm56d0xDMkVxekR6RSJ9
Request for Comments: Office of Women’s Health Strategic Priorities
July 10, 2020
www.fda.gov/womens
Dear Women’s Health Colleagues,
We recognize the unique role FDA plays in protecting and promoting women’s health and the value of input from all our stakeholders. Today I am sharing a way for you to help us ensure that important women’s health topics are carefully considered when establishing the scientific, educational, and outreach priorities of FDA’s
Office of Women’s Health. Please take a moment to submit your comments to the public docket below. Your feedback is critical to our ability to advance the health of women.
Sincerely,
Kaveeta Vasisht, M.D., Pharm.D. Associate Commissioner for Women’s Health Director, Office of Women’s Health
------
FDA Office of Women’s Health is Seeking Your Feedback on Strategic Priorities
To maximize the FDA Office of Women’s Health’s ability to promote, protect, and advance the health of women, we are seeking input on research priorities driven by data gaps and areas of unmet need; topics for education among consumers, health professionals, and other stakeholders; and outreach to women, especially underserved and diverse populations. We are also interested in proposed methods for acting on these priorities, such as collaborations and partnerships.
Therefore, FDA is issuing a Federal Register notice to open Docket No. FDA-2020-N-1391 for the public to submit comments. FDA will take the suggestions and information submitted to the docket into consideration when developing OWH scientific, educational, and outreach priorities.
• Submit either electronic or written comments by September 8, 2020. • Read the Federal Register Notice.
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Celebrations of Life (In memoriam)
1. Laurence “Larry” R. Dusold From: CFSANAllHandsMail
Subject: Passing of Larry Dusold
We are saddened to inform you of the passing of former FDA employee, Laurence R. Dusold on Saturday, May 2, 2020.
Larry's illustrious career spanned 46 years at FDA. He started as a research chemist in the CFSAN Mass Spectrometry Lab in 1971. In 1986, Larry was instrumental in creating the CFSAN Telecommunications and Scientific Computing Support Branch which he led for 20+years. Larry was a visionary whose contributions over the years significantly enhanced and modernized both the Agency’s scientific and IT capabilities. He built CFSAN’s first data center in FB-8 (200 “C” St SW, DC) and first E-mail system. He also saw the future promise of the internet and created the first FDA website when no one else believed it would be useful. Larry served as the lead architect of the CFSAN scientific computing program and established the framework that was expanded when OIMT was created in 2008 and is currently in use across the Agency today. Larry continued his work moving Scientific Computing forward at the Agency level in OIMT. He was the author of over 300 publications on Google Scholar and an internationally recognized expert in the field of Scientific Computing until his retirement in 2016.
CFSAN’s current research community owes a particular debt of gratitude to Larry. Although his persistence and determination in bringing new technologies into the FDA benefited scientists from all Centers, his contributions were integral to the success of CFSAN’s research programs in genomics, proteomics, and computational modeling. Our ability to continue specialized scientific work, data analysis, and monitor laboratory equipment in the current pandemic is in no small part due to Larry’s vision and leadership. Larry was also an early adopter and always ready for a discussion about the technical specifications of the latest model cell phones, laptops, or any other electronic device. He was a pleasure to work with and he will be missed.
Larry was the beloved husband of the late Karen Dusold; He is survived by his daughter Amy Breznak, husband John, and their children Emma and Ian; his daughter Lauren Dusold and her son Brennan Weschler; his daughter Patricia Morgan and her husband Jared; and his daughter Amanda Dusold.
The family is planning a mass to be held at a later date. Messages of condolence may be sent to the Dusold family at 307 Stonewall Road, Catonsville, MD 21228.
The family requests that in-lieu of flowers, donations may be made in Larry's name to the Maryland Food Bank, https://mdfoodbank.org/ .
The FDAAA benefited greatly from the work that Larry had done on our new website design with Richard Baldwin and the Communications Committee. His ability to computer-speak supported the efforts to bring the FDAAA website into the 21st century, so when you navigate through the new web site, remember Larry fondly! If you hit a snag, it was someone else’s fault…
2. Eric Abraham Eli Garber
Dr. Eric Garber, 61, born in New York, NY, passed away on March 24, 2020, following multiple chronic and acute illnesses that never diminished his spirit.
Eric earned his B.S. at City College of New York in 1978, where he studied chemistry and graduated magna cum laude. He went on to earn his Ph.D. at Brandeis University in 1983. Eric did a post-doc at Northwestern University until 1992, where he studied parameters governing the interaction between cytochrome c and cytochrome c oxidase in a wide variety of organisms. Following his post-doctoral training, Eric established an undergraduate program in biochemistry at West Virginia State University, where he taught in the Department of Chemistry until 1999. During this time, Eric met the love of his life, Lynn Rust, at a biochemistry conference, and she joined him in West Virginia in 1995. Lynn moved to North Dakota in 1996, and Eric joined her in 1999 as a Research Biologist at the Red River Valley Agricultural Research Center, USDA-ARS,
Dr. Garber joined the U.S. Food and Drug Administration’s (FDA’s) Center for Food Safety and Applied Nutrition in 2002. Eric was an extraordinary analytical scientist for the FDA. He threw himself into his work like no other, often working late into the night to complete a project. His research focused primarily on the development of methods to detect food allergens and protein toxins, and he oversaw the use of methods by FDA laboratories to analyze samples for the presence of undeclared food allergens. As part of the nation’s food defense program, and in collaboration with Tetracore, he developed a method to detect ricin and abrin toxins in foods, and his methods have been adopted by the Food Emergency Response Network (FERN). Recently, he completed the development and led the collaborative study of a method for the simultaneous multiplex detection of 14 food allergens and gluten. His research led to numerous peer-reviewed publications and research presentations, and the methods he developed are still routinely used by the FDA to safeguard consumers.
Eric strongly believed in the mission of the FDA and always argued for the best possible science to protect public health. Eric strongly felt that he served the American consumer who paid his salary, and he would argue vociferously for them.
Eric had a keen sense of social and professional justice. Eric never judged a person’s character by their appearance or ethnicity, but rather would let people reveal their character through their words and actions. In this way, he developed a diverse network of close and trusted friends that he would engage in wide-ranging and long-winded discussions. He also knew the importance of family and cultivated bonds with his parents, sisters, and sisters’ families, and restored once-lost bonds with his uncle’s family.
Eric is survived by his wife, Lynn Rust; his sisters, Anne Myers (Larry) and Debra Englander, and his nieces and nephews; his aunt, Joyce Garber, cousins and cousins’ families; and wide circle of friends.
In lieu of flowers, memorial donations may be made to The Rourke Museum, Moorhead, MN: https://www.therourke.org or The Fargo Theatre, Fargo, ND: https://fargotheatre.org .
3. Donald Boyd Hare
Don Hare passed away peacefully with loved ones by his side on January 4, 2020 at Transitions LifeCare in Raleigh, North Carolina.
Donald was born on November 17, 1929 in Clairton, Pennsylvania. He and his wife Dorothy raised 6 daughters, and have 21 grandchildren, and 23 great grandchildren.
Don served in the United States Army and in the United States Public Health Service Commission Corps, under the military branch of the Coast Guard, where he advanced to the rank of Captain. He served the community as a Pharmacist for the National Institutes of Health (NIH) and as a Special Assistant to the Director of Generic Drugs for FDA.
Don worked at FDA from 1978-2008 and was widely regarded as the founding father of the generic drug program. Don was a man whose grand physical stature was far surpassed by the generosity of his heart, abundance of knowledge, keen memory, and everyday humility. He will be sorely missed by the countless colleagues and friends who so greatly admired and loved him.
4. Dr. Barbara Ferguson Harland
Dr. Barbara Ferguson Harland Died peacefully in her room at Kensington Park Senior Living in Kensington, Maryland on April 29, 2020, at the age of 95. Barbara was born on April 16, 1925 in Chicago, Illinois. She graduated from Iowa State University in 1946 and completed her doctorate degree in Nutrition from the University of Maryland in 1972. She married Jim, her high school sweetheart in 1948. Barbara was an avid tennis player, and could be seen on the courts at the age of 90. During the course of her career she worked in nutrition research at the Food and Drug Administration and was a tenured professor at Howard University for almost 30 years. Her graduate students greatly appreciated her as their mentor. Until the age of 90, Barbara continued to work in her lab, with the help of graduate students, doing nutrition research on the chemical compound, Phytate.
A Memorial service is not scheduled at this time. An endowed Scholarship Fund has been established at Howard University in honor of Barbara, (Checks) Howard University College of Nursing and Allied Health Sciences, (Note section: Dr. Barbara F. Harland Scholarship for Nutrition), and mailed to: Howard University, P.O. Box 417853, Boston, M.A. 02241-7853. Online credit card gifts to Howard University can be made at: https://giving.howard.edu/givenow">giving.howard.edu/givenow. Please indicate that the gift is in Memory of Dr. Barbara F. Harland and in addition select "Other" and type in College of Nursing and Allied Health Sciences.https://giving.howard.edu/givenow . Please indicate that the gift is in Memory of Dr. Barbara F. Harland and in addition select "Other" and type in College of Nursing and Allied Health Sciences.
5. Donald Kennedy
Former FDA Commissioner and Stanford University President Donald Kennedy died from COVID-19 according to his wife, Robin Kennedy.
Kennedy, 88, who experienced a stroke in 2015, died on Tuesday morning, April 21, at Gordon Manor, a residential care home in Redwood City, where he lived for the past two years.
In an email announcing his death, Robin praised his care at Gordon Manor and addressed his illness.
Photo courtesy Robin Kennedy.
"After a week with no fever, he took a turn for the worst on Saturday night. All measures were taken to ensure he did not suffer. He was peaceful and comfortable during his final days. Many in our family were able to say goodbye to him via FaceTime on Sunday night," she said.
Kennedy was born in New York City on Aug. 18, 1931, and attended Harvard University, where he earned a bachelor's degree (1952), a master's degree (1954) and a doctorate (1956). A neurobiologist, his scholarly research centered on the properties of small nerve cells. He pioneered a new technique of dye injection into single nerve cells so that specialized cell parts — the whole axon, dendrite and cell body of the cell — can be seen in the light of the microscope.
Here’s is my memory from my first briefing of Don Kennedy. I was outlining the proposed provisions of the performance standards for sunlamps under the Radiation Control for Health and Safety Act. I recall thinking that it wasn’t very exciting to talk about timers and goggles… So, and not for the last time with a Commissioner, I went off script and opined that, of course, based on the UV radiation emitted by sun lamps and the associated skin cancer risk, we could just ban sunlamps. Kennedy instantly showed both his grasp of the issue and his sense of humor when he remarked “can’t you at least wait for my California tan to fade before you suggest we ban the sun?” Right then and there it was clear to me that he would be a real asset as Commissioner! I remember that was a good feeling. Alan
6. Maurice Dale Kinslow
Maurice D. Kinslow, 87, of Lakeway, TX passed away January 12, 2020 in the presence of his loving wife Leslye. Maurice was born June 16, 1932 to Marvin and Hazel Kinslow in New Albany, Indiana. He graduated from New Albany High School and Georgetown College in Kentucky and went on to a distinguished career at FDA.
Maurice joined FDA in July 1961 while participating in a management development program for the Department of Health, Education and Welfare. He became a staff assistant in the office of the Commissioner and during that time also participated in a congressional fellowship program for eight months on Capitol Hill. He next became a Director of FDA's Office of Legislative Affairs and served in that position until December 1969, when he became Special Assistant to Commissioner Dr. Charles Edwards. Maurice then became Assistant Commissioner for Program Coordination and served in that position until September, 1971. His final FDA position was as Regional Food and Drug Director at FDA's Atlanta field office.
Maurice is survived by his wife Leslye; children Carol Copenhaver and Scott (Candace) Kinslow of Indianapolis, IN; grandchildren Brian (Channing) Copenhaver, Samantha Copenhaver, Olivia , Joseph, and Nathan Kinslow, all of Indianapolis, IN; and sister Janet Popp of Cincinnati, Ohio. Maurice was preceded in death by parents Marvin and Hazel Kinslow of New Albany, IN, and sons James M. Kinslow and Dale B. Kinslow of Indianapolis, IN.
Memorials may be sent to Lake Travis Community Library, 1938 Lohmans Crossing, Austin, TX 78734 and Music Ministry at the Lake Travis United Methodist Church, 1502 Ranch Rd. 620 N, Austin, TX. 78734.
Maurice remembered –
Maurice and I were both separately trained by Winton Rankin, a former deputy commissioner of FDA in the 60s. I knew Maurice first as my boss and later on as a close personal friend and colleague. Maurice had a major involvement in a lot of noteworthy FDA matters including the passage of the Kefauver Harris Drug Amendments of 1962, and congressional hearings examining FDA‘s involvement with the Consumer Protection and Environmental Health Service and separately criticisms the agency received in a book called “The Chemical Feast” published by an organization backed by Ralph Nader – Phil White
Having worked with Phil after he joined CDRH after the merger of the Bureaus of Radiological Health and Medical Devics, I got to experience Maurice mostly vicariously, although I did meet him a couple of times and the photo above captures his habit of tucking his chin, which seemed such a part of his personality. I do remember how Phil White’s eyes would light up whenever he talked about his friend Maurice! Clearly, they were very close personally and shared a keen sense of the role of FDA in ensuring public health and safety. Alan
7. Milan “Mike” Kubic
Milan Kubic, or Mike as we knew him at FDA, died at age 92 on January 18th at his home in Bethesda. Mike was a Newsweek magazine journalist for 30 years and then worked as a speechwriter for 25 years at FDA. Mike was born in Prague and fled the communist government in what was the Czechosolvakia in 1948. He joined Newweek in in 1958 and was a reporter in Chicago and Washington, then was Newsweek bureau chief in Rio, Beirut, Bonn, Vienna, and Jerusalem. He worked on crafting speeches for FDA Commissioners and others until his retirement from FDA in 2015.
Mike remembered -
I hired Milan "Mike" Kubic upon my return to FDA in 1989 when the FDA speech writing staff was created. Mike had recently retired after a thirty-year career at Newsweek magazine, where he had served as a correspondent in Washington, D.C., before moving on to cover all of South America in the 1960s, and Europe from Bonn when Germany was still divided. He then served for more than a decade as Newsweek's bureau chief in Jerusalem. For more than 25 years, Mike researched and wrote speeches for the Commissioner, Center directors, and other senior FDA officials. He was also a steady presence in the Office of Public Affairs, lending his news judgment and editorial skills to FDA's news releases and in mentoring younger press officers.
Mike was modest, introverted, and almost shy (unusual traits for a reporter), but his life story was fascinating. Born in Prague between the two world wars, he came to the U.S. as a refugee after WW II, served in the U.S. Army, and graduated from the Medill School of Journalism. He told his story in the memoir of his first career, "From Prague to Jerusalem: An Uncommon Journey of a Journalist." It was published in 2016, the year after he retired.
One episode exemplifies the kind of person Mike was. Soon after he joined FDA, I met with Mike at his home office in Bethesda to discuss an upcoming speech. Above his desk hung a framed photograph of Mike with Robert F. Kennedy. They were in canoes on a river. It turns out that Mike knew RFK very well, and the photo showed them on a vacation trip on the Amazon River in Brazil. But Mike would never have told me about this friendship unless I had seen the photo myself. In a town known for name dropping, this was unusual.
Before I hired Mike, I checked his references. One of them, a Newsweek editor in New York, told me I would be lucky if I could hire Mike. He was right! - Larry Bachorik
8. Catherine Lorraine
Catherine Lorraine passed away March 23, 2020, surrounded by her husband of 40 years, Hank Willner, M. D. and sons Jonathan and Daniel. She was 70. She was born on July 24, 1949 in Richmond, Virginia, one of four siblings, to Charles Kemper Lorraine and Shirley Irene Hillstead. She attended Mary Washington College for two years then transferred and graduated from Yale University. She achieved her J.D. from the University of Virginia Law School. Catherine turned her gifts and talents into a career driven by service to others. After a brief stint in the U. S. Department of Education she joined the Food and Drug Administration in 1986 and worked there until two weeks before her death.
There she distinguished herself as a fierce defender of public health in her role as counsel, as leader of the Policy Development Staff in the Office of the Commissioner, and with instrumental contributions to establishing the Agency's jurisdiction over tobacco products and creating the Center responsible for that regulation. She was driven to help others, and was an outstanding manager and mentor, shaping and enriching the careers and lives of many colleagues. With" a presence that ran from fearless to angelic," Catherine led with kindness, humility and compassion, providing warmth and joy to her legions of friends and colleagues. She was a beautiful, eloquent, and graceful lady, who exuded wisdom and perspective.
Here is the announcement from the Commissioner:
Colleagues and friends, I was saddened to learn that a beloved member of the Office of Policy, Legislation and International Affairs’ (OPLIA) team, Catherine Lorraine, passed away recently from a rare cancer. My heart goes out to her family and everyone at FDA who had the privilege of working with Catherine during her more than thirty-five years of service to this Agency. I write to offer my condolences and to honor Catherine’s extraordinary contributions to advancing public health throughout her career.
Catherine joined FDA in 1982, and she served as a fierce and thoughtful advocate for the Agency as a lawyer in the Office of the Chief Counsel, as a founding member of the Center for Tobacco Products, and, most recently, as a Director in OPLIA’s Office of Policy. Among Catherine’s many accomplishments, she was instrumental in developing FDA’s 1996 rule “Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents”—the prescient tobacco product rule that first addressed FDA’s role in regulating cigarettes—which were, and remain, the single leading cause of preventable death and disease in the United States. As an oncologist, I have witnessed the devastating consequences caused by smoking. It is remarkable to consider how Catherine’s work contributed to the series of events that ultimately led to passage of the Family Smoking Prevention and Tobacco Control Act, marking a fundamental victory for public health in America.
In recent years, Catherine was indispensable to advancing key goals, such as implementation of the 21st Century Cures Act and addressing our hiring challenges. But one of Catherine’s most enduring legacies will have been her development of others around her. Catherine possessed a special ability to lead and nurture; to give others the tools and room to grow professionally; to challenge and shape others’ thinking while being supportive and compassionate. We have all benefited tremendously from her decades of mentorship—of developing talent and expertise in others, then sending them off to do great things at FDA and the greater public health community.
Although we aren’t able to gather to celebrate Catherine’s memory right now, I hope you’ll join me in remembering her through our work every day. Together in our current fight to turn the tide on COVID-19, I see daily evidence of the kind of spirit and dedication that embodied Catherine’s service to the Agency. I am proud to lead and work alongside our remarkable OPLIA team to advance the great mission of FDA and to continue Catherine’s legacy.
Warm regards,
Steve
Stephen M. Hahn, M.D. Commissioner of Food and Drugs
9. Alexander "Al" Anthony Ondis
Al Ondis,79 of Owings Mills passed away on Thursday, May 7, 2020. Husband of Olivia (Maiorisi) Ondis for 56 and ½ years! Father of Michael (Kristine) Ondis, Anthony S. Ondis, Karen T. Ondis, Sandra (Mark) Carroll. Brother of Janice Mantia. Loving grandfather of Andrew Ondis, Katherine and Ryan Carroll.
Al was born June 3, 1940 in Providence, RI, the son of the late Alexander and Theresa (Gazerro) Ondis. He worked for 43 years at the Food and Drug Administration.
Al remembered –
Former Baltimore District Director, Tom Hooker, wrote that Covid-19 took Al’s life. Tom noted that Al was a former Supervisory Investigator in Baltimore.
10. Walter Staruszkiewicz, Jr.
Walter was born on January 31, 1939 in Elwood City, PA. He received his BS degree from Geneva College in 1960 and his MS from the University of Hawaii in 1965. He was at FDA, CFSAN for 41 years working in seafood safety. His work provided the scientific basis for international standards for the safe handling of fresh fish and processed seafood.
11. Richard (Dick) Crout, MD
CROUT J. RICHARD CROUT, M.D. Dr. J. Richard ("Dick") Crout passed away on July 9, 2020 after a long battle with bladder cancer. He was the loving husband of Carol K. Crout for 66 years and the proud father of daughter Linda Spevacek of Naples, FL, son Keith of Rockville, MD and son Andrew of Newark, DE, and grandfather to Carl and Dylan Spevacek. Dick was a physician scientist who loved his family, his public service to the nation and the beauty of the planet we live on. Dr. Crout was best known professionally for serving as the Director of the Bureau of Drugs at FDA from 1973-1982. This was a particularly formative period in FDA history just after the thalidomide episode and passage of the New Drug Amendments of 1962. He was a key leader in developing the policies and regulations that govern to this day the regulation of drugs in the U.S. He recruited young physician-scientists, statisticians, pharmacists, and epidemiologists who provided a generation of leadership for future decades. Dick always felt grateful to have had the opportunity to serve at the beginning of an era, triggered by a new and powerful law. Few people have such good luck. The details of drug regulation have evolved through the years, but the science-based foundation built then remains. During his career, Dick was called to testify at some 50 Congressional hearings and had several appearances on 60 Minutes with Mike Wallace. Dick rose to the rank of Rear Admiral and in 1977 was awarded the Distinguished Service Medal of the Public Health Service, its highest honor. Dick also holds an honorary Doctor of Medicine from Uppsala University in Sweden. Dick was born in Portland, Oregon on December 30, 1929. His family later moved to the Midwest where he went to high school in Columbus, Ohio, and then to Oberlin College (g. 1951) and Northwestern University Medical School (g. 1955). During his senior year of medical school he married his sweetheart, Carol Keith of Kalamazoo, MI, thereby rescuing her from a PhD. program in psychology at the Univ. of Michigan. Before going to FDA, Dick was in academic medicine at the University of Texas Southwestern Medical School in Dallas and at the Michigan State College of Human Medicine as head of Clinical Pharmacology. In 1984 Dick joined Boehringer Mannheim Pharmaceuticals Corporation as its Vice President for Medical and Scientific Affairs. He also served on the Board of the U.S. Pharmacopeia and, after his retirement in 1994, on several biotech boards. Carol and Dick sailed on the Chesapeake Bay for 16 years in their Tartan 37 sailboat Ragtime and knew almost every gunkhole north of Mobjack Bay. They sailed charters in New England, the British Virgin Islands, Belize and Turkey. They barged with friends for six weeks in France on the Canal du Midi and the canals of Burgundy and Brittany. In retirement they were members of the No Name Wine Group, and Dick played tennis for 35 years with a group of FDA friends. Every summer was reserved for their beloved cottage in Michigan on Elk Lake near Traverse City-a place of fun and beauty, with life-long friends as neighbors. With the help of the local land conservancy, he and his family have supported the preservation of more than a mile of shoreline and over 1000 acres of farmland and forest in the Torch River-Lake Skegemog area of Michigan. Dick greatly enjoyed his last 10 years living at Ingleside at King Farm, a retirement community in Rockville. He was the first chairperson of the Healthcare Committee and a member of several other committees and the Men's Book Club. Though never having sung before, he became a decent tenor in two choruses and loved it. A memorial concert will be held at a later date. Memorial donations for a conservation project in Dick's name may be sent to Grand Traverse Regional Land Conservancy, 3860 North Long Lake Road, Suite D, Traverse, MI 49864. Published in The Washington Post on Jul. 13, 2020.
Dear friends, I am very sorry to inform you that Dick Crout passed away on July 9, peacefully with family members nearby. He had fought a long battle with bladder cancer. The family is doing as well as can be expected, and we are relieved that his struggles are over.
An obituary from The Washington Post may be found online here: https://www.legacy.com/obituaries/washingtonpost/obituary.aspx?n=j-richard-crout&pid=196484159
The family would like to thank you for all that you contributed to Dick's life over the years. He was an amazing man with intellect and heart. We know you join us in our mourning, but also our celebration of his memory.
As you may know, Dick was a strong proponent of protecting water quality and land preservation. A memorial project is planned in his name near his beloved lake in northern Michigan. Donations to this project on his behalf may be made to: Grand Traverse Regional Land Conservancy Attn: Dick Crout Memorial Fund 3860 N. Long Lake Road, Suite D Traverse City, MI 49684
Wishing you health and sanity in these crazy times.
Sincerely yours Carol, Linda, Keith and Andrew
Carol K. Crout 701 King Farm Blvd. #202 Rockville, MD 20850 301-330-3560
Dick Crout FDAAA Tribute 7-20-20 Stuart L. Nightingale, M.D.
I have had the privilege of having known Dick Crout for almost 45 years. I met him first when he interviewed me for the position of Assistant to the Director of the Bureau of Drugs in 1976. Taking that position was one of the best decisions I ever made, and the experience confirmed my desire to work in public service for the rest of my career, which I did.
Dick was wonderful to work for -- a great mentor, colleague, and friend. His love of FDA was infectious. Dick was so effective not only because of his expertise but because of his kindness, work ethic, modesty, integrity, collegiality, and genuine concern for his staff and colleagues throughout the agency. His Bureau of Drugs Holiday Parties with two punch bowls, one safe and one effective, didn’t hurt either!
He loved the challenges of complex scientific, regulatory, and administrative problems. His goal was to solve them, not just debate them, and he did this often through deft utilization of the administrative and regulatory process.
During the time that Dick was the Bureau of Drugs Director, FDA leadership faced many challenges as the agency reorganized, grew, and provided the framework for many basic administrative structures that remain today. Other challenges came from the outside – Congress and a number of external committees were established to examine and make recommendations for improving the FDA new drug review process. He strengthened FDA’s oversight of drug advertising, generic drug regulation, the OTC drug review and DESI process, greatly improved the advisory committee system, recruited large numbers of medical and scientific staff to strengthen the new drug review process, and established a priority review process for drugs that would be important therapeutic advances.
Dick was truly the right person to be in charge of drugs during the 1970’s, a time of many changes at FDA. He was not only a well-respected expert academic pharmacologist but, importantly, he was a rare breed of physician-scientist who respected and understood the importance of clear regulation followed up with strict compliance.
Some of my favorite memories of my time working with Dick include his establishing a small group of Bureau physicians to address Laetrile promotion and use by sending them to state capitals to serve as resources to state legislatures as they considered bills that would legalize Laetrile. He asked me to coordinate the development and updating of model FDA testimony and to schedule appearances with the field. We had a good deal of success but the final blow to Laetrile, of course, was the clinical trial conducted by NIH. Dick also took aim against other health frauds and quackery. Other memorable events include the development of a patient package insert pilot project that eventually led to the medication guide, an initial approach to dealing with Direct-to-Consumer drug advertising, informing physicians of FDA’s off-label drug use policy, and convening the inaugural meeting of the International Committee of Drug Regulators (ICDRA) to promote information sharing and eventual harmonization. This led eventually to many spin-offs including the ICH and influenced the convening of similar regular meetings on foods, medical devices, and veterinary medicine.
Dick was interviewed a number of times for 60 Minutes by Mike Wallace and others. I helped prepare background for some of these and enjoyed watching the filming. Dick was articulate, explained scientific issues clearly in lay language, and expertly handled the many difficult and loaded questions.
My memories touch on just a few of the many important and lasting contributions that Dick made that have affected the well-being of patients in the United States and worldwide.
Dick and I stayed in touch over the years. My wife and I enjoyed getting together for dinner with Dick and his wife Carol, often together with Mark Novitch and his wife Louise. I will miss Dick greatly. Stuart L. Nightingale, M.D.
As always, if you have a remembrance of any of these FDAers that you want to share, please let us know at [email protected] .
F. Alan Andersen, PhD FDAAA Past President