More than two dozen speakers, including an expert in dietary supplement and breast cancer advocate, vented frustrations today a lack of long-time transparency to the US Food and Drug Association. The unusual gathering, held in Washington, and webcast, is the most visible sign yet further efforts by the FDA to better communicate with the public and to clarify its scientific process. In the spirit of openness, the FDA has also launched a "transparency website" at the beginning.
The meeting was an opportunity for the FDA's various stakeholders to describe their effort trying to wring information from the often secretive agency. Bray Patrick-Lake, a young woman who participated in a clinical trial of a cardiac device designed to ease migraines, she and frustrations of a fellow participant described trying to communicate with the FDA after problems arose in the trial. Several speakers urged the FDA to release more information about its releases with companies, including discussions on medical treatments before they are approved or rejected. The agency normally will not confirm or deny whether the examination of an application for a new drug.
There are also a lot of confusion about how the FDA weighs scientific evidence. Public meetings, for example, advisory committees of the FDA, could reveal some problems with treatment, but the final action of the FDA seems to contradict what was up there. Diana Zuckerman of the National Research Center for Women and Families in Washington, says the silicone breast implants for example. In this case, the data presented at a public meeting several years ago laid the implants in a poor light; The product was then approved without a clear explanation, Zuckerman recalled. "We do not have access to find out why" FDA made the decision he did.
Not surprisingly, industry representatives are not big fans of the show-all and -Comes back they have with the FDA on a regular basis, mostly, they said, because of fears it could tip off the competition. Just revealing a meeting between a company and a particular branch of the FDA could be damaging, noted Andrew Emmett of the Biotechnology Industry Organization, if it suggests a company is considering expanding the use of a drug or a particular device.
the working group, which composed of senior officials from the FDA and is headed by the Senior Deputy Commissioner Joshua Sharfstein, will try to analyze how transparent it is ready. the group, who complained a speaker would do well to include those of the outside the agency, will use the meeting, comments on the blog, and other contributions to make recommendations to the newly installed FDA chief Margaret Hamburg later this year.
0 Komentar