June 7, 2010

Berman Institute faculty to lead FDA-sponsored exam of drug study issues

The director and a core faculty member of the Johns Hopkins Berman Institute of Bioethics have been appointed co-chairs of an Institute of Medicine committee that will evaluate the scientific and ethical issues involved in studies of drug safety after FDA approval.

Ruth Faden, director of the Berman Institute of Bioethics, and Steven Goodman, a professor of biostatistics at the Johns Hopkins Kimmel Cancer Center and a faculty member at the Berman Institute, will lead the 12-member Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs.

“Rarely does the Institute of Medicine appoint two scholars from the same university to be committee co-chairs,” Faden said. “I am honored to serve with Steve, and for the opportunity to make a contribution to this significant challenge to the nation’s health.”

The group’s immediate priority will be to deliver on July 1 a brief report outlining the ethical issues that must be considered when designing clinical trials to evaluate the safety of drugs after they are on the market.

Longer-term goals of the committee will be to evaluate the scientific and ethical merits of various approaches to generating evidence about the safety of drugs that are approved and marketed; consider the cost, speed and value of those approaches; and determine when head-to-head clinical trials for safety are appropriate.

The committee—sponsored by the Food and Drug Administration and comprising bioethicists and experts in drug safety, research methodology and public health—is expected to issue a final report by next spring.

An initial open session will be held today, June 7, in Washington, D.C. Speaking at the event will be Margaret Hamburg, commissioner of the Food and Drug Administration; Francis Collins, director of the National Institutes of Health; and Carolyn Clancy, director of the Agency for Healthcare Research.

The Institute of Medicine is a nongovernmental organization that advises the federal government on controversial issues in science, medicine and engineering. IOM committees have played a critical role in advancing policies and practices in medicine, public health and science. Established in 1970, the IOM is the health arm of the National Academy of Sciences.

For more on the committee’s project.