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  5. Marion J. Finkel - Leader in Orphan Product Development
  1. FDA History Exhibits

Marion J. Finkel - Leader in Orphan Product Development

Marion J. Finkel (245px)Marion J. Finkel was born in New York City and received her medical education at the Chicago Medical School, where she earned her M. D. in 1952.  After a residency in Internal Medicine that included two years at Bellevue Hospital in New York, she had a private practice and worked for the pharmaceutical industry. FDA hired Dr. Finkel as a medical officer in 1963, as the agency began implementing the most significant shift in drug regulation since 1938, the Drug Amendments of 1962, and she moved into increasingly important administrative positions in drug management.

By 1968 she was Director of the Division of Metabolic and Endocrine Drugs, one of six divisions in the Office of New Drugs.  Two years later she became Deputy Director of the Bureau of Drugs, and then she was appointed head of New Drug Evaluation in 1974, which included all drug categories as well as scientific investigations.  So, Dr. Finkel had thus achieved a position of perhaps the greatest responsibility by a woman up to that point in the history of federal drug oversight.

The 1970s also was a challenging time in the history of drug regulation, with intense and competing pressure coming from industry and its loyalists, consumer activists, Congress, and even dissent within the agency on issues of drug approval, and she worked closely with the Bureau of Drug Directors to help bridge some of their concerns.  One noteworthy development in this period that Dr. Finkel led was a system to provide for the submission of safety and efficacy evidence for off-patent, post-1962 drugs without repeating the data gathering of the initial NDA-holder. Repetition of animal and clinical trials, as the agency argued, would be unethical as well as wasteful of scientific resources. So, aside from providing evidence of the generic drug’s equivalence to the original and establishing acceptable manufacturing practices, the agency accepted published reports that adequately demonstrated a generic drug’s safety and efficacy. Such was the framework for the so-called “paper NDA” that Dr. Finkel’s plan laid out.

Marion J. Finkel (2)
Panhematin (hemin) was among the earliest orphan drugs.

Also in the mid-1970s, she chaired the agency’s Committee on Drugs of Limited Commercial Value, an activity that foreshadowed the next stage in Dr. Finkel’s FDA career.  After eight years in charge of new drug evaluation, she was named Director of Orphan Product Development in 1982.  In this post she ushered in FDA’s administration of the 1983 Orphan Drug Act, which aimed to provide medicines for rare, commercially untenable diseases through a variety of inducements to industry.  She left the agency in 1985, by which time her office had designated 54 drugs with orphan status, 31 of which were either on the market or well on their way.

Dr. Finkel moved on to work in industry, but by the time she left FDA her contributions had been recognized with the FDA Award of Merit and the Presidential Meritorious Executive Award, among other distinctions.  Her scores of publications are testament to her wide-ranging interests in drug regulation, including clinical pharmacology, orphan product development, the construction of clinical trials, and pediatric drug studies.  And her commitment to public health for over twenty years at FDA, as with the contributions of all the women portrayed in this section, represents a legacy the agency takes pride in during Women’s History Month and beyond.

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