On July 1, 2014, the United States Food and Drug Administration published its draft Strategic Priorities for 2014-2018 in the Federal Register.¹ The draft identifies and explains the FDA’s strategic intentions and overall plans through 2018 applicable to the FDA’s oversight of food, tobacco and medical products. This article summarizes the information included in the draft Strategic Priorities that are important to the drug and medical device industry and which forecast the next four years of the agency’s activities.

The draft contains two main sections: the FDA’s cross-cutting strategic priorities and its core mission goals and objectives. The “cross cutting” priorities – which are meant to be interpreted appropriately for each regulated area – are (1) regulatory science, (2) globalization, (3) safety and quality, (4) smart regulation and (5) stewardship. The draft includes limited, general detail about these cross-cutting priorities, while significantly more attention is given to the following four “core mission goals and objectives:” (1) enhance oversight of FDA-regulated products, (2) improve and safeguard access to FDA-regulated products to benefit human health, (3) promote better-informed decisions about the use of FDA-regulated products, and (4) strengthen organizational excellence and accountability. While the fourth goal relates primarily to the administrative operation of the FDA, the first three of these core priorities each directly impact drug and device manufacturers. Each of these core goals is examined in greater detail below.

CORE GOAL 1: ENHANCE OVERSIGHT OF FDA-REGULATED PRODUCTS

The draft identifies four objectives under the broad umbrella of enhancing oversight of regulated products. First, the agency intends to increase the use of regulatory science to inform standards development, analysis and decision-making. While consistent with past practices of the agency, the draft highlights the FDA’s emphasis on employing new technologies and advances in regulatory science for postmarket surveillance and the monitoring of products in the distribution chain for the validation of safety and toxicity signals. The draft also indicates that the FDA intends to advance the development of predictive safety models and improve its methods for safety detection and validation.

The second objective under the oversight goal is to reduce risks in the manufacturing, production and distribution of FDA-regulated products.² The portion of the draft addressing this objective highlights the FDA’s efforts to focus on the quality of products and to trace products through the supply chain. The draft indicates that the FDA will continue to encourage submission of NDAs using Quality by Design (QbD) elements that are intended to ensure product quality, and the agency will also encourage the use of the Case for Quality Initiative with medical devices. This section also emphasizes that the agency intends to “increase access, sharing and use of global data from foreign, Federal, State, local and private sources to aid in assessment of risk related to FDA-regulated” products. Finally, the draft indicates that the agency will increase its prior efforts related to counterfeiting by reducing the availability of substandard and illegally marketed products.

The third objective – to strengthen detection and surveillance of problems with FDA-regulated products – relates directly to the FDA’s postmarket surveillance of regulated products and indicates that the FDA will continue to expand its efforts to move from passive to active surveillance systems. The draft states that the agency intends to increase its use of both the Sentinel Initiative³ and the National Medical Device Postmarket Surveillance Plan as part of its efforts to bolster active postmarket surveillance. These efforts will also include the continued monitoring of Internet sales and a generally described effort of improving the overall quality of the agency’s surveillance systems.

Fourth, the agency intends to improve its response to problems with regulated products. This objective includes the agency’s continued focus on preventing and responding to drug shortages and detaining or destroying unsafe and counterfeit products. This section highlights the agency’s powers under the Food and Drug Administration Safety and Innovation Act (FDSIA) to monitor product quality and the agency’s goal of collaborating with domestic and international partners to respond to global safety threats.

CORE GOAL 2: IMPROVE AND SAFEGUARD ACCESS TO FDA-REGULATED PRODUCTS TO BENEFIT HEALTH

The first objective under this goal, increasing regulatory science capacity to effectively evaluate products, recognizes that rapid advances in science – including gene therapy and nanotechnology – require the FDA to “keep up” with the science to regulate effectively. To effect this goal, the agency indicates that it will improve its regulatory science capacity by increasing collaboration, training and information sharing with the scientific community and industry, strengthen its own infrastructure, and support public-private partnerships to advance regulatory science, including the Medical Device Innovation Consortium (MDIC).⁴

The second objective for improving and safeguarding access is to improve the effectiveness of the product development process. This objective explicitly recognizes the significant slowdown in the development of products (such as antibiotics) that are crucial to public health, as well as the cost impediment of bringing new medical products to market. The draft states that if “biomedical science is to deliver on its promise, scientific creativity and effort must also focus on improving the medical product development process itself, with the explicit goal of robust development pathways that are efficient and predictable and result in products that are safe, effective and available to patients.”⁵ To effect this objective the agency intends to: (i) improve the evaluation of methods, tools and models used in the development and testing of medical products; (ii) advance the development of medical products for rare diseases; (iii) enhance communication between FDA and sponsors during the development process; (iv) facilitate the application of advanced technologies and methods and relevant scientific discoveries – such as newly identified clinical biomarkers, adaptive clinical trial designs and genomics – to regulated products; and (v) improve the tools and approaches needed to catalyze the development of personalized medicine.

The third objective for this goal is to “improve the predictability, consistency, transparency and efficiency of the review process.”⁶ In recognition that product innovation and development in the current economic climate require early clarification of regulatory requirements, the agency is working to make the review process more transparent and to increase its productive communication with sponsors. The draft indicates that the FDA is committed to achieving an efficient process for the exchange, review and management of information with drug and biologic applications and that it intends to improve its review efficiency. The agency will focus on the electronic submission of data, an electronically managed review process (eMRP), data standardization and data integrity to achieve this efficiency. The draft also states that, for this objective, the agency intends to increase its consideration of health disparities and health outcomes in regulatory decision making.

CORE GOAL 3: PROMOTE BETTER INFORMED DECISIONS ABOUT THE USE OF FDA-REGULATED PRODUCTS

The three objectives under this goal largely relate to the quality and content of communications with the public and health professionals about safety information,⁷ and the objectives are in large part not specifically tied to measures directly impacting drug and device manufacturers. However, the second of these objectives – improving patient and provider access to benefit-risk information – includes priorities which may impact industry’s use of social media and the use of Risk Evaluation Mitigation Strategies (REMS). The draft indicates that the agency will expand its focus on the use and monitoring of social media and websites to disseminate risk communication alerts and safety information, and these efforts will likely overlap with the agency’s recent activities related to social media.⁸ This portion of the draft also states that the agency intends to standardize and better integrate REMS into the healthcare system.

CONCLUSION

Although the FDA’s draft priorities for 2014-2018 remain subject to revision, the core goals to provide oversight of regulated products and improve and safeguard access to regulated products are in keeping with past practices of the agency. The draft guidance provides clear recognition of the need for the FDA to partner with agencies across the globe, and the emphasis on technology in global surveillance is consistent with the global marketplace. Finally, the draft’s enumeration of the need for transparency and consistency in the FDA’s regulatory actions and the need for improvements in the FDA’s processes are important for the industry and may prove beneficial if implemented during the next policy period.

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[1] The full report is available at: http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM403191.pdf (hereafter, “Strategic Priorities”). Last accessed August 7, 2014. The period for public comment closed on July 31, 2014, but a revised draft incorporating comments has not yet been published.

[2] Strategic Priorities at 18.

[3] The Sentinel Initiative allows the FDA to query health care data holders, such as electronic health record systems and insurance claims registries, to evaluate potential safety issues.

[4] The MDIC was formed in 2012 to create an independent entity focused on advancing medical device regulatory science at an industry level. See http://mdic.org/.

[5] Strategic Priorities at 26.

[6] Id. at 28.

[7] The three objectives are to: (1) strengthen social and behavioral science to help patients, consumers and professionals make informed decisions about regulated products; (2) improve patient and provider access to benefit-risk information about FDA-regulated products; and (3) improve safety and health information provided to the public. Id. at 30.

[8] See, e.g., Guidance for Industry – Internet/Social Media Platforms with Character Space Limitations. Available att: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM401087.pdf. Last accessed August 7, 2014.

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