IV. FDA is pursuing a strategy with four primary componets to address the coming challenges
In order to cope with the magnitude of the fundamental shifts on the horizon, FDA is committed to substantially and fundamentally revising its approach to global product safety and quality. Over the next decade, FDA will transform itself from a domestic agency operating in a globalized world to a truly global agency fully prepared for a regulatory environment in which product safety and quality knows no borders.
To achieve this transformation, the agency is developing an international operating model that relies on enhanced intelligence, information sharing, data-driven risk analytics, and the smart allocation of resources through partnerships.
The new approach rests on four core building blocks:
1) FDA, in close partnership with its foreign counterparts, will assemble global coalitions of regulators dedicated to building and strengthening the product safety net around the world.
2) With these coalitions, FDA intends to develop a global data information system and network in which regulators worldwide can regularly and proactively share real-time information and resources across markets.
3) FDA will continue to expand its capabilities in intelligence gathering and use, with an increased focus on risk analytics and thoroughly modernized IT capabilities.
4) FDA will effectively allocate agency resources based on risk, leveraging the combined efforts of government, industry and public- and private-sector third parties.
FDA and its partners around the world have already taken steps to set the foundation for the work ahead. Bilateral relationships with regulatory counterparts and collaborative workplans exist with several countries. Interactions with foreign counterparts in the development of common standards and capabilities have been immensely helpful in building positive working relationships with a number of different countries. Engagement in these discussions has also given FDA valuable insight into the challenges that others have been facing. The lessons and successes from its involvement in programs like the Codex Alimentarius Commission, International Conference on Harmonisation (ICH), PIC/S, and Global Harmonization Task Force (GHTF) are critical building blocks for the collaboration envisioned in this strategy for global product safety. In addition, there is urgency to effect change that enhances global product safety and quality given the major shifts already well underway.
A. FDA will partner with foreign counterparts to create global coalitions of regulators focused on ensuring and improving global product safety
Increasingly, national borders no longer define the challenges of ensuring product safety and quality. FDA and its foreign counterparts have acknowledged this reality and undertaken efforts to increase collaboration among regulators and standardization of manufacturing requirements and inspection procedures. As the agency moves forward, FDA envisions a much deeper engagement, beginning with a core group of partners. The primary aim of this effort would be to develop procedures for more comprehensive and systematic information sharing and coordinated deployment of resources. This would be achieved in a timely manner by focusing on comparability--elements or features of a regulatory system that give confidence it will produce comparable safety outcomes to the benchmark system. Focusing on comparability will be faster and likely more effective than harmonization, in which a regulator only recognizes the similarities of a peer system.
Traditionally FDA has had close cooperation with a series of regulatory partners via bi-lateral agreements. While FDA has built strong relationships with its counterparts, a broader and more comprehensive model is required going forward to achieve the change required. Global coalitions are not new and there are several models operating today that successfully govern global commerce. For example, the International Civil Aviation Organization (ICAO) was formed to promote global cooperation and common standards to ensure safe, secure, and efficient civil air traffic. ICAO has successfully operated for over 60 years and now has more than 190 members.
In the medical products context, several models exist today. For example, PIC/S was formed in 1970 to strengthen cooperation in the field of inspections with a view to maintaining mutual confidence and promoting quality assurance. PIC/S has grown significantly since formation and now has over 35 members (including the U.S. as of January 2011). Similarly, earlier this year, senior leaders of the GHTF decided to create an expanded global regulators’ forum for medical devices. The forum’s objective is to promote convergence across global device safety activities. This will extend GHTF’s traditional role of developing and leveraging guidance documents to engagement with countries that are, or are likely to become, influential in medical device manufacturing and regulation.
Based on a review of existing governance models there are several key principles that must be established for a successful global coalition. First, the coalition needs an overarching organizing body to facilitate regulation and promote key functions. Second, sovereignty should be maintained and respected, and nations should maintain control of their own borders, markets, and standards. Third, the coalition should rely on common science-based standards as a baseline for judging the other members’ effectiveness at product quality and safety assurance. Fourth, the coalition should focus on comparability and not equivalence, as public health impact and outcomes are more important than identical standards. Finally, it will be essential to establish clear membership standards supported by an effective auditing process to ensure member compliance.
The building of global coalitions is consistent with the direction of FSMA. The new law explicitly recognizes that all food safety agencies, domestic and foreign, need to work together in an integrated way to achieve our public health goals. The law directs FDA to develop a comprehensive plan to expand the capacity of foreign governments and their industries, including training of foreign governments and food producers on U.S. food safety requirements. FDA is explicitly authorized to rely on inspections of other Federal, State, and local agencies to meet its increased inspection mandate for domestic facilities. FSMA also allows FDA to enter into interagency agreements to leverage resources with respect to the inspection of seafood facilities, both domestic and foreign, as well as seafood imports.
B. FDA will work to build a global data-information system and network and proactively share data with peers
It will be essential to FDA’s quality and safety efforts that the agency be able to aggregate and utilize multiple sources of information as inputs to intelligence and regulatory analysis to identify potential threats. This is a key enabler of more sophisticated risk assessments and models than are currently possible. In order to share information efficiently within the agency as well as with domestic and foreign counterparts, FDA will develop or locate systems capabilities and processes to manage the secure, smooth exchange of information. As a first step, the agency will work with coalition partners to identify critical data elements needed to inform risk models and standardize the reporting of this information to allow for the seamless and automated flow of data. Internally, it will work to make necessary changes and build new capabilities that enable the agency to transmit information to and receive information from a wide variety of sources. Through the development of robust global coalitions, FDA will work with its partners to craft a process for regular, systematic information exchange that will provide an ongoing input into FDA’s risk modeling, various analyses, and, ultimately, the deployment of agency resources to achieve greater public health impact.
The most effective global coalitions have built sophisticated systems to share data across markets. Interpol, the International Criminal Police Organization, has developed sophisticated data systems that allow broad, timely intelligence sharing to facilitate law enforcement across participating agencies worldwide. Interpol has also successfully developed systems that facilitate information exchange between members of varying technological expertise. The World Meteorological Organization (WMO) has established tightly managed data standards to ensure quality and homogeneity through non-real time data assessments. Global product safety coalitions of the future must possess similar capabilities. While FDA may be hindered by legal restrictions on its ability to share data in the absence of a legislative change, a global data-information system will be a critical enabler to building effective and empowered global coalitions.
C. FDA will expand its capabilities in intelligence gathering and use, with an increased focus on risk analytics and thoroughly modernized IT capabilities
With an ever-growing roster of manufacturers and producers to monitor, FDA plans to build deeper capabilities in intelligence gathering and risk analytics. Scaling the current model for regulatory operations is simply not viable from a resource utilization standpoint. Intelligence capabilities will give FDA a more sophisticated understanding of the potential threats facing U.S. consumers with the ultimate goal of detecting and addressing risks before they materialize into public health harms. FDA must first identify the signals and warnings of potential risks that it will monitor and then focus the organization on gathering the intelligence that will monitor the signals.
In addition, analytics capabilities will allow FDA to interpret and act on the intelligence gathered. To enhance its analytics capabilities, the agency will work to provide advanced training to current analytics experts as well as bring in new employees with significant analytical talent and experience to complement and fill needs not met by current staff. To build the necessary support infrastructure, FDA will focus on creating or identifying IT tools that allow experts to quickly access and analyze data across the various information resources available. At the heart of FDA’s effort to be a smarter, more proactive safety agency lies the analytical horsepower to make timely, effective decisions.
D. FDA will effectively allocate agency resources based on risk, leveraging the combined efforts of government, industry, and public- and private-sector third parties
One of the most fundamental changes that FDA will undertake is a more effective deployment of its own global safety resources. The agency will continue executing the broad range of surveillance, intervention, and enforcement activities that are currently its primary tools for preventing product-related harms. As FDA evolves and continues to become a more agile, forward-looking, intelligence-driven organization, these activities will be more directly aligned against a robust set of risk-based priorities, with agency staff spending a more significant share of their energies on the products and producers around the globe that represent the greatest potential harm to public health. At the same time, FDA will maintain broad-based oversight of the entire range of products within its purview by developing compliance and inspection programs that contemplate enlisting public and private third parties to conduct audits and other oversight activities on behalf of FDA.
FDA intends to establish a review and audit infrastructure to verify the integrity of the information that it receives from public and private third parties and to ensure that the agency can rapidly take follow-up enforcement measures or actions where needed. In addition, industry’s own safety monitoring efforts will also be a critical support for more comprehensive oversight. By balancing its own resources with the additional capacity afforded by leveraging these public and private third parties, FDA will achieve greater coverage of the public health risks that exist and create the flexibility to quickly shift its attention to the most pressing dangers as they arise.
Increased reliance on audits conducted by public and private third parties aligns with FDA efforts to enhance oversight of medical devices. Soon after passage in 2002 of the Medical Device User Fee Modernization Act, FDA launched a program to permit agency-accredited third parties to inspect device manufacturers. A 2006 FDA-Health Canada pilot program authorized accredited third parties to conduct facility inspections that meet FDA and Health Canada regulatory requirements. And more recently, FDA published a draft guidance allowing manufacturers to submit third-party reports of inspections conducted under International Organization for Standardization 13485:2003. FDA is currently building on these efforts to create a single audit program for medical devices.
The increased use of public and private third parties is also consistent with the spirit of the recently passed FSMA, which directs FDA to establish a program through which qualified third parties can certify that compliance with U.S. food safety standards. This certification may be used to facilitate the entry of imports. (The audits performed under this section will however not be considered inspections under section 704 of FDA’s Act.)