More than a year has elapsed since the Obama administration first promised a more transparent government, but all we have seen at the FDA is an elongated public input gathering process by the Transparency Task Force on the expectations of the agency’s numerous diverse constituencies.
For drug sponsors, transparency means predictability and responsiveness in getting products to market, for the news media it means swift and direct access to and candor from FDA decisionmakers, for public health activists it means openness and accountability in the FDA’s dealings with regulated industry about product safety…and so on.
On that latter score, goaded by the Congress, activists and the media, the FDA’s secretive drug safety review process hasn’t waited for the Transparency Task Force to produce its findings.
Last summer the Drug Safety Oversight Board (DSOB) finally succumbed to four years of public criticism and began issuing detailed public summaries of its closed-door meetings. Early public communication of emerging drug risks is a sensitive matter in the industry. As illustrated by the FDA’s January admission that a second look at new data had found no increased cancer risk in Vytorin and Zetia, a valuable drug can be needlessly maligned and patient and prescriber confidence needlessly shaken by premature publicity.
That “early communication” substantially predated the new DSOB policy on fuller and explicit public summaries of its meetings, but the example illustrates the delicate balancing act FDA has to perform.
For other areas of the agency’s transparency initiative, the stakes should not be as high.
James G. Dickinson is editor of Dickinson’s FDA Webview (fdaweb.com)
From the February 01, 2010 Issue of MM+M - Medical Marketing and Media
