Posted: 03 Nov 2016 06:57 PM PDT
By Jennifer M. Thomas –
Last week, FDA rolled out a new online reporting program, titled “Reporting Allegations of Regulatory Misconduct,” with little fanfare. No blog post in FDA Voice, no press conference, and even the (longwinded) name of the program seems calculated to send the message “nothing to see here, folks.” Which, of course, made us take a closer look.
The most likely candidates to use the easy, anonymous, online tool are competitors. This may be an attractive alternative to a trade complaint, with the added benefit that FDA is obligated to follow-up on the allegations. Some companies may simply seek to disrupt a competitor’s business by initiating an FDA investigation. The overall quality and reliability of information FDA receives from competitors probably will be low.
While it is possible that employee whistleblowers will also use this tool, those with significant and well-documented allegations have the potentially much more lucrative option of reporting regulatory misconduct though a qui tam False Claims Act suit. Reporting through this new tool in advance of filing such a suit could have implications for the whistleblower’s ability to recover as a qui tam relator.
It also is highly unlikely that FDA will be able to handle the number of reports that come in through the online reporting tool. As with medical device adverse event reports, the Agency will be forced to prioritize a very few reports, only to then be taken to task for failing to identify or act on serious violations reported to the Agency. See, e.g., GAO Letter Report, Medical Device Reporting: Improvements Needed in FDA’s System for Monitoring Problems with Approved Devices, GAO/HEHS-97-21 (Jan. 29, 1997) (here); GAO Highlights, Shortcomings in FDA’s Premarket Review, Postmarket Surveillance, and Inspections of Device Manufacturing Establishments, GAO-09-370T (June 18, 2009) (here).
First of all, allegations of regulatory misconduct, even if baseless, can disrupt a business as the Agency takes steps to investigate those allegations by conducting inspections, demanding a response from the company, etc. Whereas previously CDRH was under no affirmative obligation to respond to a complainant who, for example, submitted an unreliable or inadequately documented complaint to the Agency, CDRH now has committed to “follow-up communication” and a tracking system. This will allow submitters to demand a response, and will likely necessitate more, and more burdensome, investigative steps by CDRH.
Furthermore, these reports of allegations will be consolidated in a single repository, ripe for requests from the public or other government agencies. Although the reporting tool’s homepage states that records will not be released pursuant to FOIA until an investigation is complete, other government agencies – State Attorneys General, and U.S. Attorneys’ Offices, for example – may request pertinent documents from FDA even during the pendency of an investigation. Relators’ counsel in qui tam cases may also request to see records of an ongoing investigation.
Finally, the fact that allegations are not made public until after an investigation is closed does not necessarily protect companies from bad press tied to baseless accusations. For instance, FDA may close an investigation upon concluding that the allegation does not warrant expenditure of CDRH resources, but without reaching an actual conclusion. The reported allegation would then potentially be subject to disclosure under FOIA, and the company forced to defend itself against that allegation in the court of public opinion.
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