The Proposed Rule requires sponsors of clinical studies to report information indicating that any person has, or may have, engaged in falsification of data collected as part of a clinical study to the appropriate FDA center no later than 45 calendar days after the sponsor become aware of the information.

The U.S. Food and Drug Administration (FDA) published a proposed rule, Reporting Information Regarding Falsification of Data (Proposed Rule), in the February 19, 2010, Federal Register. The Proposed Rule requires sponsors of clinical studies to report information indicating that any person has, or may have, engaged in falsification of data collected as part of a clinical study to the appropriate FDA center no later than 45 calendar days after the sponsor become aware of the information.

FDA is proposing this revision, in part, to address its determination that sponsors have been reluctant to, or uncertain of the necessity of, reporting suspected data falsification in clinical studies to FDA. FDA states that it has two primary goals in proposing the new rule: first, to ensure the integrity of data relied upon by FDA to make determinations relating to safety and efficacy; and second, to protect the safety and welfare of clinical study subjects. Comments on the Proposed Rule may be submitted to FDA through May 20, 2010.

Brief Summary of the Proposed Rule

Who Is Responsible

Under the Proposed Rule, FDA defines a “sponsor” broadly and to cover, generally, the party supervising a clinical study regulated by FDA. For example, for purposes of the Proposed Rule, a sponsor would include a petitioner submitting a food additive, color additive nutrient content or health claim; a manufacturer or distributor submitting new dietary ingredient notifications; a sponsor of non-clinical laboratories; an IND sponsor for an investigational new drug application (IND); a sponsor for an investigational new animal drug or product; and an IDE sponsor for an investigational new device exemption (IDE).

What Must Be Reported

FDA defines “falsification of data” as “creating, altering, recording, or omitting data in such a way that the data do not represent what actually occurred,” and defines “data” as inclusive of “individual facts, tests, specimens, samples, results, statistics, items of information, or statements made by individuals.” Sponsors are required to report data falsification by any person involved in a study conducted by or on behalf of a sponsor, or relied upon by a sponsor, including individuals responsible for conducting studies as well as their colleagues or subordinates.

When It Must Be Reported

Sponsors of clinical studies must report suspected data falsification 45 calendar days after the sponsor becomes aware that falsification may have occurred. This obligation is ongoing—it covers the period of time that the study is underway and continues even following review, approval or authorization of the product or label.

How It Must Be Reported

When a sponsor reports suspected or known data falsification to FDA, the sponsor must include, at a minimum, the following elements:

  • Name of the person(s)
  • Last known address(es) and phone number(s)
  • Specific identity of the potentially affected study, including, when applicable, application information, such as application number, investigational protocol number, study title, study site(s) and study date(s)
  • Information describing the falsification

Enforcement and Penalties for Noncompliance

The Proposed Rule states that a failure to report data falsification may constitute a violation of § 301 of the Food, Drug and Cosmetic Act or a False Statement (18 U.S.C. § 1001), which are punishable as criminal offenses.

Additional Considerations

Although the Proposed Rule does not require that sponsors undertake any additional or specially tailored monitoring to identify data falsification, the Proposed Rule would likely require that sponsors take additional compliance steps, and raises a number of compliance considerations:

  • Because of the 45-day reporting rule, sponsors may be required to report allegations of falsification before the sponsor has sufficient time to complete an investigation into whether the falsification actually occurred.
  • Sponsors may want to revisit research study agreements and other research-related contracts to confirm that they will be timely notified of concerns of data falsification.
  • In cases where the research study in question is federally funded, multiple reports to different federal agencies—for example, the Office of Research Integrity, FDA and the Office of Human Research Protections—may need to be coordinated. These offices may have different processes for how to investigate allegations of falsification that may require different reports at different stages of the process. This may be of particular concern to research institutions that also serve as sponsors, since their research misconduct policies (which cover falsification) likely have a different timetable.
  • Sponsors will need to develop and implement standard procedures to monitor and report suspected data falsification. For example, sponsors should consider developing an investigative procedure that can quickly determine whether complaint or data irregularity rises to the level of suspected data falsification, and if so, should have procedures to quickly respond to the issue, identify the problem, collect and report appropriate information to FDA, and take corrective action, as applicable.