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FDA to require researchers to disclose interests

WASHINGTON (February 2, 1998 4:13 p.m. EST http://www.nando.net) - The Food
and Drug Administration said Monday that it wants to be informed of any
business interests that researchers may have in new drugs and medical devices
that come before the agency for approval.

The agency said it will require drug companies to make the disclosures under
rules that will go into effect in a year.

"Although some have argued that there is nothing inherently wrong with
scientists in the private sector and academia having financial interest in the
products they study, FDA must be aware of these relationships," FDA Deputy
Commissioner Michael Friedman said in a statement.

The agency said it wants information about researchers' compensation that
could be affected by the outcome of their studies.

It also wants to know of any patents held by researchers or significant equity
interest in the marketing company.

The FDA said it also wants information on any other significant payments to
researchers by drug companies, such as grants for ongoing research,
compensation in the form of equipment, retainers for consultation, or
honorariums.

"This regulation will help assure that the process is thoroughly open and
above-board," Friedman added.

The agency said it intends to propose similar disclosure requirements for
submissions dealing with foods and animal drugs.

Copyright 1998 Nando.net
Copyright 1998 Reuters News Service

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