Mary Margaret Richardson
Mary Margaret Richardson came to FDA’s Kansas City District Office in 1965, soon after earning her Bachelor’s degree in Biology. She was among the first group of female investigators in the agency. In this part of her oral history she recalls that experience and some of the practical challenges she faced—as one of less than a half-dozen women in that position, and as a novice investigator.
Most of FDA's oral history interviews capture officials' entire career at the agency, but the interview with Carol Sanchez was one among a group conducted to help document FDA's response to Hurricane Katrina—and that disaster’s impact on some of the staff in New Orleans. Ms. Sanchez came to FDA in 1974, held various positions of increasing responsibility, and in July 2005 began as the Director of Investigations in the New Orleans District Office, the month before Hurricane Katrina devastated the southeastern U. S. Here she recounts how the New Orleans office, relocated to Nashville, dealt with the FDA's investigational needs and how they lent assistance to state food and drug agencies.
Lois Adams arrived at FDA’s Office of Administration in 1970 with a background in financial management and organizational planning. As a program analysis officer, she was the primary liaison between the agency and the Government Accountability Office, which frequently conducted studies of the agency. Ms. Adams also spent twenty years as a non-scientist member of FDA’s internal Research on Human Subjects Committee, the subject of this portion of her oral history.
Under Project Hire in the early 1970s a wave of employees joined FDA following a budget request from the President for over 1000 new FDA positions. About three-fourths of those were dedicated to the field, and FDA filled nearly half of those positions with women and minorities. Debbie Ralston, who retired in 2008 as the Director of the Office of Regional Operations in the Office of Regulatory Affairs, discusses her arrival at the New York District Office during Project Hire in 1972: her perceptions as one of just a few female investigators in New York, as well as her experience with the Bon Vivant vichyssoise botulism case.
In 1952 FDA organized a small group of women, working on a part-time basis, to collect information from consumers to help inform the agency’s development of standards for foods. This group of Consumer Consultants developed into dozens of field-based Public Affairs Specialists, whose role evolved into all aspects of FDA-related consumer education. Cynthia Leggett supervised this group beginning in 1994, but this snippet recalls a part of her career 15 years earlier, when she and a colleague developed what would later be recognized as a leveraging tool to provide education to industry, particularly in cosmetics.
Catherine Carnevale was a practicing veterinarian with a degree from the University of Pennsylvania when she and her husband came to FDA’s Center for Veterinary Medicine in 1975. In private practice, she had taken care of the Eisenhower dogs and those of Chubby Checker but it was a 24 hour a day practice. At FDA, she was better able to balance her family life with her work as a Program Manager for the Pet Food Program and the Tissue Residue Program. Over the course of her FDA career she became best known for her expertise in pesticide safety. In this clip from her oral history interview, Dr. Carnevale discusses an aflatoxin crisis from the mid-1980s in which regulatory science played a key role in implementing an evidence-based decision to change aflatoxin action levels to allow safe use of this unavoidable contaminant in animal feed.
Marlene Haffner came to FDA from the Indian Health Service in 1981 when she accepted a position in the Office of Health Affairs, Bureau of Medical Devices. While there, she worked on several important products with significant defects: tampons linked to toxic shock syndrome, the Shiley heart valve, and the Dalkon Shield. She became the first Director of Orphan Products Development in 1986 and retired from that position in 2004. This anecdote from her oral history interview discusses the impact that a popular film called “Lorenzo’s Oil,” starring Susan Sarandon and Nick Nolte, had on popular perception of FDA’s regulation of an orphan treatment for adrenoleukodystophy.
Susan Ellenberg retired in 2004 as the Director of the Office of Biostatistics and Epidemiology in the Center for Biologics Evaluation and Research. A well-trained and well-known statistician, she recalls with some satisfaction her role with the Statistical Working Group on AIDS during the height of the epidemic. AIDS presented a particular challenge to statisticians called upon to create drug study protocols that would yield statistically sound results, but would also be responsive to the immediate and critical of AIDS patients and their doctors.
Stephanie Gray came to FDA in 1972 as one of the thousand or so new recruits brought in under Project Hire. She was hired as one of only three Consumer Affairs Officers in the San Francisco district. After a short but ill-fated detail as a field investigator, she returned to CAO work but was soon assigned some additional work in compliance, at which she proved particularly adept. She became a District Director in Puerto Rico in the mid-1980s, where her experience in pharmaceutical compliance led to her selection as the Director of Compliance in the Center for Drug Evaluation and Research. She recounts many interesting adventures in her oral history interview, but in this short anecdote, she recalls how the issue of security came up at a food labeling hearing when a banana was mistaken for a gun.
Imogene (Golinger) Tibbetts
Imogene (Golinger) Tibbetts was the first female investigator hired by FDA in June, 1965. This was shortly after the landmark Civil Rights Act of 1964 had been enacted prohibiting discriminatory hiring practices based on race, color, religion, sex, or national origin. President Johnson, in signing the historic legislation, announced that the federal government would “lead” rather than “follow” the private sector in recruiting and hiring women. At the time she came to the New York District she was 20 years old, with a B. A. from New York University and a former high school science teacher. In announcing her selection, FDA Commissioner George Larrick took pains to note that her strong academic record made her a “quality candidate” under Civil Service regulations and made it clear that she would receive the same training as all FDA inspectors. In this portion of her presentation for Women’s History Month back in 2000, she recalled the place that fashion, or lack of it, played in helping to define the work of the early women hired as field inspectors.
Nancy Ostrove, an experimental social psychologist by training, came to FDA in 1989 and became closely involved in issues such as direct-to-consumer advertising of prescription drugs, patient medication guides, and risk communication strategies. This snippet from her oral history addresses her interactions within the agency in the evaluation of the format and content of prescription drug and biological product labeling, and the important role of a social scientific approach.