FDA Ramps Up Transparency Initiative but Still Exploring Whether to Include CR Letters
On January 16, 2018, FDA Commissioner Scott Gottlieb, M.D., delivered a presentation, “Fostering Transparency to Improve Public Health” to the John Hopkins Bloomberg School of Public Health. In his presentation, Gottlieb provided a context for his vision of how transparency can be a “powerful tool for innovation,” discussing two new transparency-driven initiatives and one under consideration. Gottlieb believes that these initiatives can be implemented, while at the same time protecting confidential commercial information, trade secrets, and personally-identifiable data.
Gottlieb explained that FDA’s “modern” transparency initiatives stemmed from an FDA Transparency Taskforce led by Dr. Josh Sharfstein, leading to new tools, such as a Data Dashboard, to better understand the Agency’s compliance actions, inspections, recalls, and imports. FDA’s openFDA project provides application programming interfaces (APIs) and full sets of downloadable FDA data files for numerous high priority, scalable, structured data sets, such as adverse events, drug product labeling, and recall enforcement reports. In 2016, FDA made public, for the first time, adverse events related to foods, dietary supplements, and cosmetics, as well as a CFSAN (Center for Food Safety and Nutrition) Adverse Event Reporting System (CAERS) to provide signals of potential hazards through openFDA. In addition, FDA’s website has been updated, so the public and media can search for enforcement reports for recalls labeled “not yet classified,” which may provide recall information weeks or months before the recall is classified.
Gottlieb further announced two new initiatives with his speech:
- A pilot program to disclose summaries of Clinical Study Reports (CSRs); and
- A clinical trials identifier called an NCT number to link clinical trials in ClinicalTrials.gov to FDA communications.
The CSR sections disclosed in the pilot program will include the study report body, the study protocol and amendments, the statistical analysis plan for each of the participating product’s pivotal studies, as well as clinical study summary reports. The goal is to post this CSR information soon after the product is approved. The NCT number will be used to link to various FDA activities, including advisory committee discussions, approval letters, and labeling, for the patient, academic, and scientific communities to have greater transparency for a drug product’s entire regulatory process.
Gottlieb said that FDA is continuing to explore whether it would be possible under existing regulatory authority or through a new rulemaking to release information from complete response letters (CRLs) related to clinical safety and efficacy that could have a “significant public health value.” Gottlieb acknowledged that it would be administratively burdensome to release all CRLs, which would require redacting certain proprietary information from the letters, and may no longer be relevant if, for example, a company resolved a manufacturing issue.
Gottlieb concluded his presentation with a remembrance of two public health data sets that were disclosed, which had an important impact on the public health. The Framingham Heart Study in 1948 helped to “revolutionize our understanding of risk factors for cardiovascular disease, including smoking, obesity, and high cholesterol” and led to the development of the Framingham Risk Score. Secondly, the Surgeon General’s 1964 report on smoking built upon the epidemiological evidence from the Framingham Heart Study and further helped to provide improved science and a better-informed public about the risks associated with smoking.
Gottlieb added that for open data, real world data, wearable and implantable diagnostics, and advanced clinical trials designs to reach their full potential, they will need to be validated through transparent processes that gain the trust and confidence of all stakeholders.
Arent Fox's Food, Drug, Medical Device & Agriculture group will continue to monitor developments in this area. If you have any questions, please contact Brian Malkin, James Ravitz, or the Arent Fox professional who regularly handles your matters.