US consumer group Public Citizen has attacked the Food and Drug Administration for not using its advisory committees effectively when it comes to approving new drugs.
In a letter published in the current edition of The Lancet, Public Citizen lays out details of a study it made of 275 drug advisory committee meetings which found that the FDA overrules the findings of its own panels 28% of the time, “a figure higher than is generally assumed.”
The FDA has 18 drug advisory committees that provide the agency with independent advice, “but there have been virtually no quantitative examinations of how the committees function,” claimed Public Citizen, which last year also published a study on financial conflict of interest in FDA drug advisory committee meetings.
The consumer group also found that the agency often allows pharmaceutical companies “to make an oral presentation without a countervailing FDA view” and fails to present its own interpretation of the company’s data 18% of the time, “which is inexcusable.”
Its data also revealed that the FDA is holding drug advisory committee meetings less often than it did in the late 1990s. The study showed that only 24%, or 35 of 147 new molecular entities approved between 2000 and June 30, 2006, were preceded by advisory committee meetings. This represents a decrease from 1998 and 1999, when the FDA held meetings for 40% and 52% of approved NMEs, respectively.
“Advisory committees are a vital element of the nation’s drug safety net, but by failing to use these committees adequately, this resource is being squandered,” said Peter Lurie, deputy director of Public Citizen’s health research group.
The FDA refutes the claims however, and spokeswoman Julie Zawisza told United Press International that “the value of advisory committees extends beyond the actual votes. The discussion, the calibre of the discussion and ideas presented are very valuable to us and allow us to think about things in a different way.”
With regards to the FDA disagreeing with its advisory panels, she noted that “the committees are advisory; we’re not bound by their votes” and in terms of presentations by the agency, Ms Zawisza said that “sometimes we’re not able to present everything to an advisory committee in an open forum because there may be privacy or confidentiality issues.”
