Jim Dickinson recently published an article on the Medical Device and Diagnostic Industry website about the most recent Health and Human Services Office of the Inspector General (OIG) report. The report raises the issue of whether or not FDA should be forced to tighten their review process for Sponsor’s to submit complete financial disclosure information on investigators with IND/IDE applications. The article also mentions that OIG is critical of FDA’s current adverse event reporting review process. With that being said, OIG will be re-focusing a previous recommendation that FDA obtain complete financial disclosure information, as well as develop more strict device adverse event reporting review requirements.
To fully understand the backdrop of the article, let’s review the regulations. According to 21 CFR 812.43 Sponsors must obtain a signed agreement which must include sufficient, accurate financial disclosure from each investigator. Per FDA’s IND/IDE application process, Sponsors must submit a copy of the Investigator Agreement with their application. 21 CFR 54.4 specifies that a Sponsor that submits an IND/IDE application must accurately disclose or certify information concerning the financial interest of clinical investigators. Sponsors do so by submitting FDA Form 3454 to certify that investigators hold no financial conflict of interest, or FDA Form 3455 to disclose any financial interest. When investigators do hold financial interest, Sponsors are then required to explain what measures where taken to avoid bias. However, Sponsors are not required to submit the complete financial disclosure of each individual Investigator separately the way Investigators are required to submit them to Sponsors.
According to the article, OIG is critical of how FDA has currently been reviewing financial disclosure information in the following ways:
- Approving 42% of 2007 applications despite them missing adequate financial disclosure information
- Failure to adequately document approximately 1/3 of financial disclosure reviews
- Failure to take action on approximately 20% of disclosed financial interests
Additionally, OIG is critical of FDA’s policies and procedure for reviewing adverse event reports in the following ways:
- Failure to document action taken in response to adverse event reports
- Failure to respond to adverse event reports in a timely manner
- Failing to take action against manufacturer’s of user facilities that submit reports late
According to the report, OIG is recommending that FDA require Sponsors to submit complete financial disclosure information for each investigator so FDA can more appropriately determine potential bias in clinical research trials. In addition, they are recommending that FDA develop a clear procedure that will allow them to enforce the requirements for timely adverse event reporting by specifying what action may be taken with Sponsors who repeatedly fail to meet reporting timelines.
How do you feel about OIG’s recommendations? Are they too critical of FDA’s current practices? Share your thoughts.
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