The HHS Office of Inspector General (OIG) is renewing a prior recommendation that FDA require product sponsors to submit financial information on clinical investigators as part of the pretrial application process.
It also wants the agency to develop a clear protocol for reviewing device adverse event reports that specifically address following up with manufacturers who routinely submit reports late or with incomplete information. The new OIG report says the two recommendations stem from similar ones previously made that FDA has failed to implement fully.
It says FDA should ensure that sponsors submit complete financial information for all their clinical investigators. Sponsors must also ensure that reviewers consistently monitor financial information and take action in response to disclosed financial interests by using a review template and providing guidance and training to reviewers. OIG says the recommendations would improve the agency’s ability to identify financial conflicts between clinical investigators and drug sponsors that could create a potential for bias.
The report notes that an earlier OIG investigation found that FDA had approved 42% of marketing applications in FY 2007 that were missing financial information. It also says that in about one-third of marketing applications, FDA reviewers did not document a review of financial interest information, and neither FDA nor sponsors took action on 20% of marketing applications with disclosed financial interests. “When FDA did act, it did not consistently take action in response to disclosed financial interests,” it says.
OIG does say that FDA has made some progress in implementing certain aspects of the recommendations. For example, in 2011 a draft guidance was released on Financial Disclosure by Clinical Investigators. “We continue to recommend that sponsors submit financial information as part of the pretrial application process and will monitor FDA’s progress in implementing this recommendation,” it says.
On medical device safety, the report notes that a 2009 report “revealed that FDA has not documented follow-up on adverse events, nor does it consistently perform its first-time reading of adverse event reports in a timely manner. In addition, FDA rarely acts when manufacturers and user facilities submit reports late. The inability to obtain complete and usable information in adverse event reports hinders analysts’ review of the reports, and FDA makes limited use of annual reports. Overall, FDA received twice as many adverse event reports for medical devices in 2007 as in 2003; however, the number of some types of reports, such as 5-day reports, decreased. Although manufacturers submitted most adverse event reports on time, many 5-day manufacturer reports and 5-day user facility reports were late.”
The report says that a clear protocol is needed to ensure that all responsible parties report and take appropriate action in response to device adverse events. “We recommended that FDA seek legislative authority to eliminate the requirement for user facilities to submit annual reports because, other than a count of total adverse event reports, all the information in the annual reports is redundant to the originally submitted reports,” it says.