FDA moving on drug trials and disclosure
The U.S. Food and Drug Administration has set a February 1999 deadline for drug companies to begin telling whether investigators have a financial interest in the company or the product manufacturer's are trying to bring to market. The disclosure calls for the details of any financial arrangement or certification that none exists.
The criteria for disclosure are varied and include kickbacks that rise and fall based on the outcome of a given drug, or subsequent compensation as equity in the company, or compensation based on product sales. Any financial gain over $50,000 based on stock, ownership interest or other indirect means coming to pocket during the study or for one year hereafter.
Other creative payments such as research grants, honoraria, equipment or "consulting" fees over $25,000 other than the capital funds needed to conduct a study; and finally any proprietary interest an investigator may be pursuing such as patents.
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