Often considered among the most self-interested and least transparent systems in American democracy, the decennial process to redraw legislative district boundaries is now in full swing. On Monday, experts will review the results coming in from the states and discuss initiatives—from public mapping to independent commissions—to open up redistricting. Thomas Mann explains how this round may be a start toward transparency.

Editor's Note: For full disclosure, Tom Mann (joined by Norm Ornstein) filed an amicus curiae brief in Arizona State Legislature v. Arizona Independent Redistricting Commission.

James Madison would be pleased. The 5-4 decision announced today by the Supreme Court upholding Arizona’s use of the initiative to establish an independent redistricting commission is a model of constitutional reasoning and statutory interpretation. It underscores the essential connection between republican government and popular sovereignty, in which the people have the ultimate authority over who shall represent them in public office. The majority opinion quotes Madison to powerful effect: “The genius of republican liberty seems to demand . . . not only that all power should be derived from the people, but those entrusted with it should be kept in dependence on the people.”

Madison worried about the dangers of the manipulation of electoral rules to serve the immediate interests of political actors. He was himself the target of a gerrymander designed (unsuccessfully) to deny him a seat in the first Congress. The Elections Clause of the Constitution, by granting Congress the power to override state actions setting the time, place and manner of elections, was designed partly as a safety valve to contain the abuse of power by those in a position to determine which voters will hold them accountable.

Today’s intensely polarized politics drive major partisan campaigns to seize control of the redistricting authority in the states and to wield that power to boost prospects for majority standing in the House. Partisan gerrymandering is not the major source of our dysfunctional politics but it surely reinforces and exacerbates the tribal wars between the parties. A number of states have used the initiative device provided in their constitutions to establish independent commissions to replace or supplement the regular state legislative process in redrawing congressional and/or state legislative district boundaries. Such commissions are no panacea for partisan gerrymandering. Their composition and rules vary in ways that can shape the outcome. But the evidence suggests they can mitigate the conflicts of interest that are a part of the regular process and produce more timely plans less subject to judicial preemption.

The Court has upheld the right of those states to legislate electoral rules through a popular vote. Had the minority position prevailed, state laws governing many aspects of the electoral process would have been subject to constitutional challenge. And an important safety value available to the people of the states for responding to abuses of power by those in public office has been preserved.

This should not be read more broadly as a triumph of direct democracy over representative government. Many scholars who provided expert opinion supporting the majority opinion retain serious concerns about the overuse and misuse of initiatives and referendums. Instead, the decision strengthens the legitimacy of representative democracy by reinforcing the essential link between republican government and popular sovereignty.

Legislative proposals to accelerate and improve the development of innovative drugs and medical devices generally focus on reforming the clinical development and regulatory review processes that occur before a product gets to market. Many of these proposals – such as boosting federal funding for basic science, streamlining the clinical trials process, improving incentives for development in areas of unmet medical need, or creating expedited FDA review pathways for promising treatments – are worthy pursuits and justifiably part of ongoing efforts to strengthen biomedical innovation in the United States, such as the 21^st Century Cures initiative in the House and a parallel effort taking shape in the Senate.

What has largely been missing from these recent policy discussions, however, is an equal and concerted focus on the role that postmarket evidence can play in creating a more robust and efficient innovation process. Data on medical product safety, efficacy, and associated patient outcomes accrued through routine medical practice and through practical research involving a broad range of medical practices could not only bolster our understanding of how well novel treatments are achieving their intended effects, but reinforce many of the premarket reforms currently under consideration. Below and in a new paper, we highlight the importance of postmarket evidence development and present a number of immediately achievable proposals that could help lay the foundation for future cures.

Why is postmarket evidence development important?

There are a number of reasons why evidence developed after a medical product’s approval should be considered an integral part of legislative efforts to improve biomedical innovation. First and foremost, learning from clinical experiences with medical products in large patient populations can allow providers to better target and treat individuals, matching the right drug or device to the right patient based on real-world evidence. Such knowledge can in turn support changes in care that lead to better outcomes and thus higher value realized by any given medical product.

Similarly, data developed on outcomes, disease progression, and associated genetic and other characteristics that suggest differences in disease course or response to treatment can form the foundation of future breakthrough medical products. As we continue to move toward an era of increasingly-targeted treatments, this important of this type of real-world data cannot be discounted.

Finally, organized efforts to improve postmarket evidence development can further establish infrastructure and robust data sources for ensuring the safety and effectiveness of FDA-approved products, protecting patient lives. This is especially important as Congress, the Administration, and others continue to seek novel policies for further expediting the pre-market regulatory review process for high-priority treatments. Without a reliable postmarket evidence development infrastructure in place, attempts to further shorten the time it takes to move a product from clinical development to FDA approval may run up against the barrier of limited capabilities to gather the postmarket data needed to refine a product’s safety and effectiveness profile. While this is particularly important for medical devices – the “life cycle” of a medical device often involves many important revisions in the device itself and in how and by whom it is used after approval – it is also important for breakthrough drugs, which may increasingly be approved based on biomarkers that predict clinical response and in particular subpopulations of patients.

What can be done now?

The last decade has seen progress in the availability of postmarket data and the production of postmarket evidence. Biomedical researchers, product developers, health care plans, and providers are doing more to collect and analyze clinical and outcomes data. Multiple independent efforts – including the U.S. Food and Drug Administration’s Sentinel Initiative for active postmarket drug safety surveillance, the Patient-Centered Outcomes Research Institute’s PCORnet for clinical effectiveness studies, the Medical Device Epidemiology Network (MDEpiNet) for developing better methods and medical device registries for medical device surveillance and a number of dedicated, product-specific outcomes registries – have demonstrated the powerful effects that rigorous, systematic postmarket data collection can have on our understanding of how medical products perform in the real-world and of the course of underlying diseases that they are designed to treat.

These and other postmarket data systems now hold the potential to contribute to data analysis and improved population-based evidence development on a wider scale. Federal support for strengthening the processes and tools through which data on important health outcomes can be leveraged to improve evidence on the safety, effectiveness, and value of care; for creating transparent and timely access to such data; and for building on current evidence development activities will help to make the use of postmarket data more robust, routine, and reliable.

Toward that end, we put forward a number of targeted proposals that current legislative efforts should consider as the 2015 policy agenda continues to take shape:

Evaluate the potential use of postmarket evidence in regulatory decision-making. The initial Cures discussion draft mandated FDA to establish a process by which pharmaceutical manufacturers could submit real-world evidence to support Agency regulatory decisions. While this is an important part of further establishing methods and mechanisms for harnessing data developed in the postmarket space, the proposed timelines (roughly 12 months to first Guidance for Industry) and wide scope of the program do not allow for a thoughtfully-, collaboratively-considered approach to utilizing real-world evidence. Future proposals should allow FDA to take a longer, multi-stakeholder approach to identify the current sources of real-world data, gaps in such collection activities, standards and methodologies for collection, and priority areas where more work is needed to understand how real-world data could be used.

Expand the Sentinel System’s data collection activities to include data on effectiveness. Established by Congress in 2007, Sentinel is a robust surveillance system geared toward monitoring the safety of drugs and biologics. In parallel to the program for evaluating the use of RWE outlined above, FDA could work with stakeholders to identify and pursue targeted extensions of the Sentinel system that begin to pilot collection of such data. Demonstration projects could enable faster and more effective RWE development to characterize treatment utilization patterns, further refine a product’s efficacy profile, or address pressing public health concerns – all by testing strategic linkages to data elements outside of Sentinel’s safety focus.

Establish an active postmarket safety surveillance system for medical devices. Congress has already acted once to establish device surveillance, mandating in 2012 that Sentinel be expanded to include safety data on medical devices. To date, however, there has been no additional support for such surveillance or even the capability of individually tracking medical devices in-use. With the recently finalized Unique Device Identifier rule going effect and the ability to perform such tracking on the horizon, the time is now to adopt recent proposals from FDA’s National Medical Device Postmarket Surveillance System Planning Board. With Congressional authorization for FDA to establish an implementation plan and adequate appropriations, the true foundation for such a system could finally be put into place.