FDA transparency has snags

For decades, the actions of the Food and Drug Administration have been somewhat of a mystery to the outside world.  Never fully disclosing the inner workings that have led this group of health officials to a variety of health decisions for this country had created a chasm between the public and the organization.  Due to the lack of, or spotty disclosures regarding procedures, committee meetings and other inner workings Commissioner Margaret Hamburg, MD created the Transparency Initiative in 2009 in hopes of bolstering a more positive relationship between the general public and the FDA.  Transparency activities were designed to make the decision making process, and other activities available to the public quickly and easily—and in a user-friendly format.

Since 2009, the FDA has gone to great lengths to present itself as a more approachable organization.  Creating the Transparency Task Force, and a  Transparency Blog—where FDA officials cover a variety of issues and tasks of the organization in a format geared toward the general public through webinars and video opportunities.

Despite these great strides by the organization, there are still many who question the motives of such an action and cite the FDA for only publishing certain materials.  For example, rejections or denials of certain medications to the U.S. market are considered private information and is not shared, while approvals and withdrawal decisions are shaped into memos and distributed for general knowledge.

Opposition to the FDA’s practices are calling for a more clear cut way to see into the matters that are currently under wraps for the organization and continue to accuse them of only releasing certain materials. Calling to case the issue with the advisory committees that are selected to review certain drugs—and proving their point by pointing out conflicts of interest between members of the committee and the issue at hand. Opponents want the background information of all committee members to be published—and this is currently not the case.  Analysis of FDA committees showed as recently at August of this year that of 16 committees, 10 had member who were missing their background information and just this month an analysis of another committee showed that nearly 20% were missing pertinent background data. It is difficult for outsiders to trust what happens behind closed doors when it appears that what material is “transparent” can be chosen at will, and this only reduces the trust factor that is so desperately needed.

Publishing member histories is a simple step that the FDA could take.  Given the tremendous efforts of the organization to improve trust and open communication perhaps this should be considered. It is a small oversight with a big impact.   The general public has their health in their hands, and the FDA has—despite many mistakes—been entrusted with the responsibility of making sure that this country is as healthy as possible.  Taking tremendous strides to update blogs, annual reports and publish the accomplishment of company goals are all important, but overlooking the small things speaks volumes on its own.