FDA response to IOM report in works

The Food & Drug Administration will soon release its official public response to the Institute of Medicine's (IOM) report "The Future of Drug Safety: Promoting and Protecting the Health of the Public." This was the word from Steven Galson, M.D., MPH, director of the FDA's Center for Drug Evaluation & Research (CDER) at the recent annual meeting of the American Public Health Association in Boston.

"This report is a blueprint for us on how we will regulate drugs over the next period of years," Galson said. The official response will address each one of the 25 findings of IOM's Committee on the Assessment of the U.S. Drug Safety System, an effort that aims to bring the strengths of the pre-approval process to the post-approval phase.

Although Galson was unable to provide many details of actual agency actions, he did announce that five new working groups will be set up to specifically address drug safety and will be organized along the lines of the report. They will include regulatory authorities for drug safety, science, communication, resources, and culture.

Starting with the last first, Galson said that he strongly supports culture change at the agency. "Any large, dynamic organization that is so important to the nation's health has to undergo evaluation of culture periodically," he stated. Improvement in public perception of the FDA is one area that needs work. "There are members of the public who believe that every product approved by the FDA is 'safe,' but as we know, every drug has both risks and benefits, and newly approved drugs have limited safety information."

On the science end of things, the CDER director said there are huge gaps in how drugs are evaluated for both safety and efficacy and how we monitor them after approval. Galson warned that without investing more money in academic methodology development, the agency is not going to make huge strides.

As far as the resources necessary to implement the IOM recommendations, Galson said the agency is currently calculating the amount of funding required. "We're working closely with our experts to figure out what things are going to cost so we know how many additional people to hire." He jokingly added that there would be plenty of jobs for epidemiologists and encouraged audience members to apply.

The reason for the impending need for epidemiologists was explained at the meeting by Hugh Tilson, M.D., Dr.PH, professor of public health leadership, epidemiology, and health policy, University of North Carolina School of Public Health. "This report does something that is quite unique," he pointed out. "It addresses the question, 'What does industry need from the FDA?' "—a question, he said, that had never been asked before. In fact, IOM study director Kathleen Stratton, Ph.D., and colleagues invited Tilson to write a commissioned paper on how the pharmaceutical industry's practice of pharmacoepidemiology looks at the agency. "This was revolutionary for the FDA," he exclaimed.

Tilson's report said that industry needs to have a person at the FDA who understands epidemiology when the company brings its drug safety and risk management proposal to the agency. "The report said that no drug should be approved unless it has had proper epidemiologic review of what we know and don't know at the time of approval, and what further work needs to be done," Tilson explained. This is not a job that the FDA should do alone. It requires a public/private partnership in which epidemiologists from industry sit down with epidemiologists from the FDA before the drug gets approved, he said. "That is a big deal."

Overall, the speakers agreed that the FDA will need to be adequately resourced in order to become the full-service public health agency that the IOM report is calling for. Tilson pointed out that the FDA has already raised many of the issues with Congress, even before it was cited in IOM's report, but never received the backing it had demanded. He reminded the audience to watch for the official FDA response. "I hope it will say: It is true that we don't do the job, but here is the order of magnitude of funding that it will take to the do the job."