FDA Battening Conflict of Interest Hatches, Maybe
The United States Food and Drug Administration is going to get tougher on disclosure of conflicts of interest. At least that is the aim. The FDA has announced new draft guidance, which is of course subject to change and alteration, that seeks to expand transparency and disclosure when the agency grants a conflict of interest waiver when it allows an individual to participate in an FDA advisory committee meeting.
The current guidance would expand upon the disclosed information over waivers prior to an FDA committee meeting. The current guidance proposed would require the FDA to post online the name of the company or institution associated with the financial interest, along with a description of an individual’s conflict of interest if such conflict(s) exist.
Scientific advisory committees provide expert advice on scientific, technical, and policy matters, with the ultimate goal of protecting and promoting safety and public health. These are often regulatory decisions, product approvals, general policy matters, and other issues.
Why not just cut out any and all conflicts of interest on any FDA panel or anywhere inside the FDA? The reason is rather simple. It is not possible. The best and the brightest generally go to work in the private sector at drug, biotech, and device companies, or they go do work at universities or special interest groups or they go to work at other private-sector positions. With hundreds (or thousands) or ailments and treatments being sought after today and with the number of experts in some fields (or sub-sectors of fields), the FDA has no choice but to rely upon expertise from the outside…. conflict or no conflict.
Why does this matter for biohealth and biotech investors? Many many drugs have been delayed or kept off market or have been outright denied marketing that many have felt were more than approvable drugs.
JON C. OGG
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