So much for openness and enhanced oversight at FDA drug safety board!

Feb 13 2006

The Drug Safety Oversight Board, created in February 2005, was originally introduced as a measure to speed up and help regulators respond to signs of unexpected side effects following a new drug hitting the market.

The board was precipitated by safety controversies surrounding arthritis drugs such as Vioxx that engendered criticism of the FDA's role.

The new 'emboldened vision' for the FDA promised to promote a culture of openness and enhanced oversight within the Agency, to oversee the management of drug safety issues, and provide emerging information to health providers and patients about the risks and benefits of medicines.

But it seems not everyone is happy with the board's performance to date.

Late last week outside advisers were very critical of the government's efforts to improve drug safety, and are suggesting a new oversight board needs to be established with independent views and should consider meeting in public.

At present the board members are selected from senior U.S. Food and Drug Administration officials, along with experts from other government agencies.

They meet periodically, in private, to discuss how to address emerging issues and brief summaries are then released to the public.

The board is separate from other FDA drug safety activities and an external advisory panel that provides input on drug risks when the agency requests it.

The Board also promised to increase the transparency of the Agency's decision-making process by establishing new and expanding existing communication channels to provide targeted drug safety information to the public.

Dr. Peter Gross, the advisory panel chairman, has praised the FDA as "incredibly competent" but has also said the board would benefit from outside views.

Dr. Gross has it seems told the FDA that the board is set up to fail in as much as a committee which is aiming for transparency, meets in private without public representation.

Arthur Levin, director of the Center for Medical Consumers, has said the board's name is misleading as it is not a drug safety board, the model is bad, the name is bad and there is no audience.

In defense, contrary to what appears to have been the original premise,"to promote a culture of openness and enhanced oversight within the Agency", FDA officials say the board was designed to be an internal management group, in part because officials must discuss confidential company information and non government members would require a lengthy screening process for conflicts of interest that could delay action on important issues.