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Haffner Honored by Royal College of Physicians

Marlene E. Haffner, MD, MPH, director of the Office of Orphan Products Development (OOPD) at the U.S. Food and Drug Administration (FDA), was inducted as an Honorary Fellow of the Royal College of Physicians on June 21, 2005, at a ceremony in London. Twenty such Fellows are elected from throughout the world each year. Of these, no more than one or two are from the United States.

In informing Dr. Haffner that she had been selected for this honor, Sir Michael Rawlins, the director of the National Institute of Clinical Effectiveness in the United Kingdom (UK), said: "What you have done as director of OOPD has touched the lives of people in the UK more than Congress ever imagined when they enacted OD (orphan drug) legislation in 1983. And your accomplishments over the years have had a massive impact in Britain, as well as the US. It's our way of saying 'thank you' to you."

The Royal College of Physicians was established in 1518, and confirmed by a Royal Charter granted by King Henry VIII. Its purpose is to ensure high-quality care for patients by promoting the highest standards of medical practice.

Each year, its governing body recommends the election of new Fellows to join the College. Dr. Haffner was introduced under a bylaw that allows the election of "persons holding a medical qualification, but not Members of the College, who have distinguished themselves in the practice of Medicine or in the pursuit of Medical and General Science... "

Dr. Haffner, who also serves as Rear Admiral in the U.S. Public Health Service, has been director of the OOPD since 1987. In that role, she is responsible for leadership and management of the FDA orphan products development program. Her office administers $13.5 million annually in grants for clinical trials involving orphan products. To facilitate the development of safe and effective treatments for rare diseases, and to resolve issues related to patient access to appropriate therapies, she works closely with the pharmaceutical industry, academic institutions, individual researchers, medical professional organizations, and patient advocacy groups.

Dr. Haffner also has been very involved in helping groups outside the U.S. - and particularly in the European Union, Australia, and Japan - develop orphan product programs in their countries, based in part on the U.S. model.

She began her career at Gallup Indian Medical Center in New Mexico, and from 1974 to 1981 served as area director of all health services for the Navajo Indian population in a 25,000-square - mile area within the states of Arizona, New Mexico, and Utah.