Doctor concerned with health care law

Breaking news and expert analysis on legal and compliance issues

[Back To Home][Back To Archives]

From Health Law Daily, July 01, 2014

FDA Strategic Priorities set out the agency’s goals for the next four years

By Bryant Storm, JD

The FDA has issued a notice that the draft of its Strategic Priorities document for Fiscal Years (FYs) 2014-2018 is available; the FDA is requesting public comments on the document. The FDA issues a Strategic Priorities document every four years, which sets out its goals and priorities for the following four years. The document is intended to provide a framework for the methods that the FDA uses to protect the public health. The Strategic Priorities document is drafted with awareness that drugs, biologicals, medical devices, radiation-emitting products, cosmetics, food, and tobacco products all present unique regulatory challenges that need to be uniquely addressed to meet the FDA’s goals (Notice, 79 FR 37332, July 1, 2014).

Strategic Priorities. The document lists five cross-cutting priorities the FDA seeks to focus on in the next four years. The priorities include: (1) regulatory science, (2) globalization, (3) safety and quality, (4) smart regulation, and (5) stewardship. In the area of regulatory science, the FDA wants to implement new ways to efficiently evaluate and approve new products to speed up patient access to important therapies. Improving data analytics and information sharing is a key component of the FDA’s focus on globalization. The FDA is hoping to focus its efforts to advance safety by promoting quality and compliance measures within the companies that manufacture the products it regulates. Implementation of technology that is efficient while maintaining a meaningful regulatory oversight is one way the FDA seeks to use what it calls “smart regulation” to address the technological landscape of the future. The FDA continues to focus on stewardship as a core component of its responsibility and hopes to maximize tax dollars to their optimum potential in order to maintain public health.

Core mission goals. The FDA has four core mission goals that it plans to focus on in the next four years. The goals are intended to overlap each of the areas identified as Strategic Priorities and to work with them to achieve the FDA’s broader mission of maintaining public health. The agency wants to place specific emphasis on efforts to:

  • Enhance Oversight of FDA-Regulated Products
  • Improve and Safeguard Access to FDA-Regulated Products to Benefit Health
  • Promote Better Informed Decisions about the Use of FDA-Regulated Products
  • Strengthen Organizational Excellence and Accountability

With respect to oversight, the FDA plans to increase the use of regulatory science to inform standards, reduce manufacturing risks, strengthen problem detection, and improve responses to problems.  To improve access to regulated products, the FDA hopes to increase the capacity for evaluation, improve effectiveness of the product development process, and improve predictability, consistency, transparency, and efficiency throughout the entire process of product review. To help the public make better informed decisions regarding the use of FDA regulated products, the FDA plans to work towards providing more information to patients and providers regarding risks and benefits associated with the products. To strengthen the FDA on an organization level, the agency proposes to recruit and develop a world-class workforce, while improving the overall effectiveness of the FDA, and investing in infrastructure designed to help achieve those goals. The deadline for public comments on the draft document is July 31, 2014.

MainStory: TopStory FDCActNews CosmeticNews DrugBiologicalNews FoodNews FoodSafetyNews PrescriptionDrugNews

Health Law Daily

Introducing Wolters Kluwer Health Law Daily — a daily reporting service created by attorneys, for attorneys — providing same-day coverage of breaking news, court decisions, legislation, and regulatory activity.

A complete daily report of the news that affects your world

  • View full summaries of federal and state court decisions.
  • Access full text of legislative and regulatory developments.
  • Customize your daily email by topic and/or jurisdiction.
  • Search archives for stories of interest.

Not just news — the right news

  • Get expert analysis written by subject matter specialists—created by attorneys for attorneys.
  • Track law firms and organizations in the headlines with our new “Who’s in the News” feature.
  • Promote your firm with our new reprint policy.

24/7 access for a 24/7 world

  • Forward information with special copyright permissions, encouraging collaboration between counsel and colleagues.
  • Save time with mobile apps for your BlackBerry, iPhone, iPad, Android, or Kindle.
  • Access all links from any mobile device without being prompted for user name and password.