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# CDER MAPP Signals FDA Financial Ties Interest: Lawyers
- URL: https://www.fdaweb.com/cder-mapp-signals-fda-financial-ties-interest-lawyers/
- Published: 2017-07-13T12:00:00.000Z
- Updated: 2026-09-14T22:33:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139134

Four Hogan Lovells attorneys write that a recent Office of New Drugs Manual of Policies and Procedures (MAPP) [outlining](https://www.fdaweb.com/mapp-on-nda-bla-financial-disclosure/) policy goals, roles, and responsibilities with respect to financial disclosures in NDAs, BLAs, and NDA/BLA supplements is a “potential sign of renewed interest in financial ties between industry and clinical investigators.” Writing in an online blog [post](http://www.lexology.com/library/detail.aspx?g=2f8c0afa-f0f6-4e2c-a151-d09351e71534&ref=fdaweb.com), the attorneys say the financial disclosures have been required since a final rule became effective in 1999.

The post says it is significant that the MAPP notes that the adequacy of financial disclosures will be determined during an applicant’s medical review, and that the agency medical reviewer will notify the Office of Science Investigations (OSI) if it appears that financial arrangements may have affected data reliability. “In a situation where questionable study results are associated with a clinical investigator for whom financial issues were disclosed,” the attorneys write, “the MAPP instructs the medical reviewer to **(1)** consult OSI about a possible visit to the clinical site, and **(2)** request submission of further analyses of the data (e.g., an analysis of the study omitting the investigator’s data). Finally, the MAPP instructs the medical reviewer to make a recommendation to the review division on whether the specific data can be considered when taking regulatory action on the application, and to summarize in the medical review the findings of the financial disclosure review and any steps taken as a result of the financial disclosures.”

While the attorneys say it remains to be seen what the implications of the MAPP may be, they suggest that its issuance, together with a 2013 guidance on financial disclosure by clinical investigators, “may signal the agency is planning to focus more systematically and closely on assessing potential bias in clinical data based on clinical investigators’ financial interests.”