WASHINGTON (Reuters) - U.S. regulators need to improve lax oversight of the financial conflicts of doctors who test medicines before they are approved for sale, a government watchdog report said on Monday.
The Food and Drug Administration lacks a complete list of doctors conducting research on new medicines and cannot determine which companies have submitted financial information for all doctors working on studies, according to a report by the Department of Health and Human Services inspector general.
Investigators examined materials submitted for 118 marketing applications of medicines or medical devices approved in fiscal 2007.
Forty-two percent of the applications were missing financial information, the report said. The FDA did not document a review of any financial data for 31 percent of the applications.
The report urged the agency to take several steps to make sure companies submit complete financial information for doctors and that agency reviewers check the submissions.
It also said the FDA should require companies to submit financial information for doctors before clinical trials on people begin.
The FDA objected to that idea, saying it would add another layer of review that would not necessarily help patients.
“This recommendation could have the unintended effect of adding to the complexity and cost of the clinical trial enterprise with no commensurate gain in the protection of human subjects or the quality of the data,” FDA spokeswoman Karen Riley said.
The agency agreed with the report’s other recommendations, Riley said.
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