On November 21, 2014, the National Institutes of Health (NIH) published a notice of proposed rulemaking that would expand the clinicaltrials.gov registration and results reporting provisions first created by the Food and Drug Administration Amendments Act (FDAAA) in 2007. (Notice available here.) NIH would require posting of results for clinical trials of unapproved and uncleared products.
NIH’s action follows the October 2, 2014 release of the European Medicines Agency’s (EMA’s) policy on the publication of clinical trial data. The current NIH proposal would not go as far as the EMA policy, which will require the EMA to publish clinical reports, and eventually individual patient data, that are submitted to the Agency in marketing authorization applications (The EMA Policy is available here). Such a requirement is still a possibility in the United States, however, as the Food and Drug Administration (FDA) has considered whether this might be appropriate under certain limited circumstances. In June 2013, the FDA published a request for public comment on the proposed availability of de-identified and masked data derived from medical product applications and what limitations or factors the FDA should consider in such disclosure. The comment period was reopened in October 2013. Stakeholders interested in clinical trial transparency should continue to monitor both the NIH and FDA dockets, as well as the various international proposals. (Notices available here and here.)
NIH’s long-awaited proposal significantly expands the scope of current clinical trial reporting requirements. Most notably, the proposal requires results reporting for all “applicable clinical trials,” regardless of whether the drug or medical device being tested has been approved or cleared by the FDA. “Applicable clinical trials” include all controlled studies of drugs, biological products and medical devices that are regulated by the FDA with the exception of phase one studies of drugs and biological products and device feasibility studies. Sponsors would be required to submit certain specified results data, including data about adverse events, no later than one year after the trial’s completion. A delay of up to two years would be permitted for investigations involving unapproved or uncleared products if the sponsor certifies its intent to continue product development. The proposal also requires the reporting of additional data elements in both registration and results submissions. A chart of proposed clinical trial registration and reporting data elements can be found here.
NIH opted not to require submission of technical and non-technical clinical trial summaries or submission of the trial protocol. With respect to the summaries, NIH “deferred” the decision, stating that it was not convinced that a brief summary could provide sufficient background or context to avoid being potentially misleading. Such a requirement could implicate FDA’s regulations prohibiting pre-approval promotion. The issue of posting clinical trial summaries should be monitored in conjunction with FDA’s current review of the scope of permissible scientific exchange. The FDA docket on scientific exchange can be found here.
Comments on the proposal are due to NIH by February 19, 2015. The following topics should be considered as stakeholders prepare to comment:
- NIH’s proposal for the publication of unapproved or uncleared medical device registration information in light of statutory language prohibiting such publication until after approval or clearance;
- The potential submission of technical and non-technical summaries and the assessment of whether such summaries can be executed in a useful, objective, and non-misleading way;
- NIH’s proposed approach to the reporting of adverse event data and whether there are ways to increase standardization or reduce the data submission burden without reducing the value of the data;
- Practical considerations related to the proposed form and manner for submitting data elements, including whether proposed menu options are sufficient to accommodate the range of potential entries;
- NIH’s decision to limit the delay available unapproved or uncleared products to two-years and whether it is sufficient to protect commercial interests in such products;
- What constitutes “good cause” for an extension of reporting requirements under 42 U.S.C. § 282(j)(3)(E)(vi);
- Privacy concerns arising out of the publication of the additional clinical trial data elements required by the proposal; and
- NIH’s proposed timelines for updating information and correcting factual errors.
If you have any questions regarding this update, please contact one of the following Sidley lawyers:
Lauren R. Silvis
Food, Drug and Medical Device Regulatory
Global Life Sciences Practice
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