Regulatory Focus™ > News Articles > Regulation on Research Misconduct Withdrawn by FDA

Regulation on Research Misconduct Withdrawn by FDA

Posted 11 January 2013 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) has withdrawn a final rule that it had published just a few months ago, saying that it will once again allow access to records regarding scientific research misconduct proceedings involving its staff.

The regulation had been put forth as a "direct final rule," which is unusual in that it calls for comments even though it did not go through the advanced notice of public rulemaking (ANPR) process. FDA's 1997 guidance on the use of direct final rule procedures notes that it only uses it "when the agency does not anticipate receiving any significant adverse comment, or when a rule may qualify for exemption from notice-and-comment rulemaking."

FDA's Federal Register statement on the withdrawal makes clear that a "significant adverse comment" was the reason for the rule's withdrawal. No other reasons were cited.

The rule is now expected to re-enter the rulemaking process, this time as an ANPR, allowing for a public comment and revision process.


In the regulation, FDA said it would exempt its "system of records" on research misconduct proceedings involving FDA staff in order to "protect the integrity of FDA's scientific misconduct inquiries and investigations and to protect the identity of confidential sources in such investigations."

That system of records applies only to research performed by FDA employees, persons acting on behalf of the agency or who are contracted by the agency, and who are accused of fabricating, falsifying or plagiarizing research or results. Employees are frequently involved in signing off on records and conducting basic research, bioequivalence testing, pharmacokinetic testing and pharmacodynamics testing, among others.

Such proceedings can result in debarment and suspension from being allowed to conduct government-sponsored research, as well as civil or criminal penalties depending on the scope of the misconduct.

 The agency explained in its 28 August 2012 Federal Register notice that its proposed system of records would be modeled after the Office of Research Integrity's (ORI), the Department of Health and Human Services (DHHS) office charged with overseeing allegations of misconduct involving basic, government-funded research.

The problem as it currently stands, argued FDA, is that under the Privacy Act, employees have the right to access information pertaining to them within any non-exempt system of records. Because their current misconduct system is not explicitly exempt, any person under investigation could legally request those records, including information regarding the investigation and the identity of the person or persons who accused them of misconduct.

The docket's posting indicates that the agency received four comments through 13 November 2012, though at the time of this article's publication they had not been posted.

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