www.fdanews.com/articles/89408-fda-proposes-changes-to-focus-on-safety-transparency-in-drug-review-process

FDA PROPOSES CHANGES TO FOCUS ON SAFETY, TRANSPARENCY IN DRUG REVIEW PROCESS

January 31, 2007

The FDA acknowledged the need for greater transparency and an increased focus on safety in its drug review process through a series of recommendations it issued late Tuesday.

These recommendations respond to a highly publicized report by the Institute of Medicine (IOM), which examined weaknesses in the agency's drug review protocols.

The IOM report, which the FDA requested and funded, described an agency that is underfunded, disorganized and lacking in sufficient authority to enforce the laws. The report, "The Future of Drug Safety -- Promoting and Protecting the Health of the Public," is one of many voices raising concerns about how the agency operates.

In particular, the FDA has been under fire by lawmakers such as Sen. Chuck Grassley (R-Iowa) for being allegedly too interested in industry's concerns when reviewing drugs. Grassley, along with Sen. Chris Dodd (D-Conn.), is introducing legislation in improve the agency's postmarket surveillance through a clinical trials registry and results database that would include information regardless what the outcome of the trials were.

The FDA hopes its announced changes will address such criticism, reducing mistrust of the agency, FDA Commissioner Andrew von Eschenbach, Janet Woodcock, the agency's deputy commissioner and chief medical officer, and other agency officials said. CDER Director Steven Galson added that the agency needs to improve its culture, calling it one of the "top priorities."

The agency is pledging to include staff from its Office of Surveillance and Epidemiology (OSE) in new drug application and biologics license application decisions. Specifically, the FDA will initiate two pilot projects to determine how to better involve OSE staff in both pre- and post-marketing. The FDA has already begun holding meetings between OSE and all Office of New Drug review divisions.

"We need to improve the way scientific disagreements are handled and resolved," Galson said. (http://www.fdanews.com/did/6_22/)