On Tuesday, June 4, 2013, FDA made available for comment a proposal to make available to the public, de-identified and masked clinical and preclinical data contained in product applications submitted to the agency. To see the Federal Register notice (the “Notice”), click here.
FDA explains that the impetus for this proposal is to improve the efficiency and effectiveness of product development “by providing scientific data that may be of value in the generation of new knowledge to facilitate innovation in the development and evaluation of critically needed medical products.” For example, the agency indicates that it has used data drawn from multiple studies across different drug development programs to address important regulatory issues, such as identifying potential endpoints for clinical trials, understanding the predictive value of preclinical models, clarifying how medical products work in different diseases, informing the development of novel clinical trial designs, analyzing safety issues, and identifying potential safety biomarkers for clinical trials. Notice at 33422.
FDA is now considering a proposal to “fully realize the potential of these data” by allowing “non-FDA experts and other interested parties” to access these data for research purposes. The agency also contemplates that wider availability of such data could maximize the contribution of patients who participate in clinical trials by, for example, using a model of disease progression in control arms of future studies based on pooled control group data from past studies in the same disease or indication. Id. at 33422-23.
FDA emphasizes that data from product applications would be made available for external use only after steps have been taken to de-identify the data and remove the data’s link to a specific product, study, and/or product application. Id. at 33422. To this end, the agency explains that it considers “masked data” to be “data with information removed that could link [the data] to a specific product or application.” Id. Data could be masked in a variety of ways, such as making available a random sample or appropriate sampling of a data set, restricting the data fields provided, or pooling data from studies of multiple products in a class without identifying the specific products. The agency considers “de-identified data” to be “data that does not identify an individual and with respect to which there is no reasonable basis to believe that the information can be used to identify an individual.” Pursuant to FDA’s regulations, de-identified data would be stripped of any information that could identify patients or research subjects directly or in combination with other publicly available information. Id. at 33423.
FDA has requested comments on this proposal, and in particular on these 5 questions:
- what factors should be considered in masking study data (e.g., data fields from regulatory submissions to remove or modify, number of different products to pool within a product class);
- what limitations, if any, should there be on the Agency’s ability to make the masked data available;
- are there any additional factors FDA should consider in deidentifying data in addition to FDA’s requirement to remove any names and other information (e.g., birth date, death date, local geographic information, contact information) which would identify patients or research subjects before disclosing information;
- would regulatory changes facilitate implementation of such a proposal, and if so, what changes would be most useful; and
- which situations do you believe disclosing masked data would be most useful to advance public health?
The Notice indicates that comments should be submitted by August 5, 2013 to Docket No. FDA-2013-N-0271.
This Notice comes at a time when regulators in Europe are considering broad policy initiatives to make product-specific clinical trial data publicly available. In its own efforts to enhance transparency and advance regulatory science, FDA must grapple with—among other issues—its existing FOIA regulations, which confer protected status on data and information contained in marketing applications, and the takings clause of the U.S. Constitution. Because this Notice raises potential legal issues and represents a policy change by FDA, we urge clients and the public to take a close look at FDA’s Notice.