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Will FDA Turn the Tide on Industry-wide Medical Product Development?

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Great_Wave_off_KanagawaThe advent of big data has forced a sea change throughout the scientific research enterprise, shaking the industry’s fundamental attitude towards the data themselves. Data is now understood as the currency of research. Consequently, industry is warming to the new reality that legal norms once considered to drive business – confidential commercial information, trade secrets and intellectual property – can impede innovation and product development. Precompetitive and procompetitive collaboration among traditional competitors and the rising influence of industry outsiders, like philanthropies and patient advocacy groups, have proven that knowledge sharing is quickly revolutionizing an industry historically predicated on secrecy to drive competitive advantage.

No other entity has more power to utilize data sharing to advance the interests of public health than the U.S. Food and Drug Administration (FDA).  FDA “currently houses the largest known repository of clinical data (all of which is de-identified to protect patients’ privacy), including all the safety, efficacy, and performance information that has been submitted to the Agency for new products, as well as an increasing volume of post-market safety surveillance data.” Historically, FDA, like most of industry, has shrouded this data behind the veil of confidential commercial information or trade secrets belonging to the data’s source.[1] However, new realities in the world of medical product development – most profoundly analytic tools afforded by big data – call into question the value of keeping data secret. 

Today, discovery of new medicines is directly dependent upon building basic scientific knowledge like better understanding the etiology of disease, reaching consensus on clinical endpoints and identifying biomarkers; none of which can be done without access to volumes of data outside the purview of any single entity. Fields like precision medicine and bioinformatics that hold promise to revolutionize medical care are only as powerful as the amount of data available to researchers. Access to data on various toxicity and efficacy issues may reduce redundancy amongst competitors doing research in the same field or even revive shelved compounds or failed drug applications. And, of particular significance to the public health, encouraging transparency will increase the public trust in the research enterprise and clinical trials.

Accordingly, in June 2013, FDA publicly called for comments on a proposal to de-identify and mask data from medical product applications for the express purpose of sharing this information with outside parties for further analysis (see Availability of Masked and De-identified Non-Summary Safety and Efficacy Data; Request for Comments. [Docket No. FDA-2013-N-0271]).  In its Request for Comments, FDA recognizes that “[t]o fully realize the potential of these data, experts outside of FDA would need to become actively engaged in the research.”  While this proposal suggests that the Agency is working to realize the benefits of big data, how the data will be shared and with whom remains to be seen.

The text of this proposal clearly reflects the Agency’s need to balance industry’s concern with sharing perceived confidential information with the significance of data sharing to the public health. Specifically, the Agency called for comments on issues including what factors from the data need to be masked or de-identified; in what ways the Agency should be limited when it comes to sharing data; how this initiative should work from a regulatory perspective; and, how sharing this data will be must useful to advance public health.

The timing of this announcement is particularly interesting in light of the European Medical Agency’s (EMA) similar pledge to promote transparency by publicly releasing data from an approved product or application starting January 1, 2014. Aspects of EMA’s transparency policy already in effect are currently stalled in litigation, after the European Union General Court ruled in favor of a company suing to enjoin the EMA from disclosing what the company deemed confidential and commercially sensitive information. How the industry will respond to a similar proposal from remains to be seen, though it reasonable to assume a similarly adverse response (see PhRMA Statement on Decision of the European General Court on EMA Disclosure of Company Data).

Still, by simply initiating this proposal, FDA publicly reinforced the reality that sharing data is essential for researchers to overcome medical product development hurdles. The question is how will FDA lead the industry in implementing big data’s potential? Since taking office in 2009, FDA Commissioner Margaret Hamburg has been actively championing the FDA as a public health agency. Supporting this initiative to share previously sequestered clinical data will prove the Agency’s true commitment to the public. No matter the response to the FDA’s proposal, the world of medical product development is demanding a research enterprise that is open, transparent and cooperative.  FDA’s commitment to share its treasure trove of data will surely fulfill the prophesy reverberating throughout the industry that a “rising tide will lift all boats.” (See The FasterCures Track: Collaborating for a Cause and U.S. Food and Drug Administration and European Medicines Agency Reach Landmark Decisions on Critical Path Institute’s Clinical Trial Simulation Tool for Alzheimer’s Disease). While this proposition challenges the core beliefs that industry may still harbor about the utility of the data themselves, it is those who resist the change who will be left behind.

[1] See Pub. Citizen Health Research Group v. Food & Drug Admin., 704 F.2d 1280, 1282-86 (D.C. Cir. 1983).

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The views reflected in this expert column are those of the individual authors and do not necessarily represent those of the O’Neill Institute for National and Global Health Law or Georgetown University. This blog is solely informational in nature, and not intended as a substitute for competent legal advice from a licensed and retained attorney in your state or country.

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