FDA Publishes New Strategic Roadmap, Emphasizes Regulatory Science

By Chuck Seegert, Ph.D.

In an effort to meet the next four years head on, the FDA has put forth the 2104 to 2018 strategic priorities document. The document outlines the FDA’s five strategic priorities and establishes the agency’s core goals and objectives.

The world of healthcare, science, and technological engineering continues to increase in complexity. The Food and Drug Administration (FDA) is tasked with protecting and promoting public health while navigating this ever-changing space. This includes keeping up with the latest scientific advances and being responsive to the needs of the marketplace.

Recently in FDAVoice, the blog for the agency, commissioner Margaret A. Hamburg announced the organization’s roadmap for progress and strategic priorities. Currently the FDA oversees what represents about 20 cents for every dollar spent on products in the United States, a significant portion by any measure. In addition to products manufactured domestically, regulators must oversee imports that represent about 40 percent of what hits the shelves at drugstores and pharmacies, according to the blog. In the medical device space, this may be as much as 50 percent of what’s consumed annually.  

To address these challenges, the FDA published its Strategic Priorities 2014-2018, a more than 30 page document describing the agency’s priorities, core mission goals, and objectives. At the top of the list is development of regulatory science.

“Regulatory science is at the core of everything FDA does and therefore it influences and in turn is affected by any actions taken involving the other priorities,”  Dr. Hamburg wrote in the introduction to the document.

Innovations in regulatory science promise to enhance product development in a number of ways, according to the document. For example, new tools, models, and simulations will be available to test medical products. Clinical trial efficiency and quality should increase along with improved clarity for clinical trial endpoints, which at present may be poorly defined.

While regulatory science tops the list, it is accompanied by:

• Globalization — including the sourcing of materials internationally
• Safety and quality — as it applies to supply chain and manufacturing
• Smart regulation — a commitment to acting expeditiously without compromising the agency’s core protective mission
• Stewardship — ensuring that public investment is bringing maximum public health value

In addition to the focus on regulatory science and its impact on product development, the FDA recently released detailed guidance for manufacturers of custom devices. The document was crafted with input from industry prior to publication.