FDA responds to IOM report

The FDA has outlined the steps it intends to take in response to drug safety concerns raised in the Institute of Medicine's report, The Future of Drug Safety: Promoting and Protecting the Health of the Public (Sept. 22, 2006). Specifically, the agency plans to improve the science behind its safety system from premarket to postmarket surveillance, including instituting a pilot program to evaluate the safety profile of a new drug 18 months after approval. The FDA proposes to establish a new advisory committee to improve the agency's risk communication policies and develop a strategic plan, and also plans to use external consultants to help CDER improve its organizational culture. It also intends to include staff from the Office of Surveillance and Epidemiology in the New Drug Application decision-making process. Critics think the plan falls short and doesn't address many of the problems elucidated in the report. They claim the issues overlooked include the IOM recommendation to require drug manufacturers to publicly register their clinical trial results so physicians and patients have the most up-to-date drug safety information and the one requiring industry to perform postmarket safety studies. According to consumer advocacy group Consumers Union, the FDA must also be adequately funded in order to properly perform its public health duties.

To see more Hot off the Press news articles, click here.

To go to the Drug Topics homepage, click here.