Do Conflicts of Interest Undermine FDA Approval Decisions?Diana Zuckerman says that the latest attempt by the US Food and Drug Administration to prevent conflicts of interest among its advisory committee members is still inadequate.

摘要

Guidelines newly issued by the US Food and Drug Administration to prevent conflicts of interest among the members of its scientific advisory committees are completely inadequate.The revised rules1'9, announced in August, attempt to address criticisms and concerns surrounding the impartiality of the advisory committees that recommend whether or not the FDA should approve medical products. However, they sound surprisingly similar to the conflict of interest rules that have undermined the agency's credibility in recent years.The FDA determines whether prescription medications, medicines sold over the counter, medical devices, vaccines, or other medical products can be marketed for general sale in the US. These decisions are made behind closed doors, with very little information available to the public about the data upon which the decisions are made.