The independent drug safety oversight board will oversee the management of important safety issues such as recommending information and updates for placement on the Drug Watch, resolving disagreements over approaches to drug safety issues, assessing the need for MedGuides, and overseeing drug safety policies.
The board will be comprised of members from the FDA and medical experts from other HHS agencies and government departments and will consult with outside medical experts and representatives of patient and consumer groups.
The FDA will also improve transparency by sharing drug safety information sooner and more broadly and conveniently. It will launch a new Drug Watch webpage and proactively share tailored drug safety information sheets with healthcare professionals and patients.
“The public has spoken and they want more oversight and openness,” HHS secretary Mike Leavitt said during a meeting with FDA employees. “They want to know what we know, what we do with the information and why we do it. We will address their concerns by cultivating openness and enhanced independence.”
“FDA understands that the public expects better and more prompt information about the medicines they take everyday,” said acting FDA commissioner, Dr Lester Crawford. “Our goal is to prepare the agency for these new demands by improving the way we monitor and respond to possible adverse health consequences that may arise regarding drugs that have been approved for sale to US consumers.”