Improving FDA's scientific know-how and regulatory tools while strengthening enforcement activities will be top priorities for the agency over the next five years, according to a new strategic report.

The draft report, published Sept. 30, addresses cross-cutting issues that span all seven FDA product and research centers and two main offices, as well as center-specific projects that the agency will focus on from fiscal 2011 through fiscal 2015.

FDA identifies four overarching priorities: advancing regulatory science and innovation; strengthening the global supply chain; strengthening compliance and enforcement activities; and addressing unmet public health needs.

"Today, FDA's job is fundamentally different - and far more complex - than it was even a few years ago," the agency asserts in the report.

FDA Commissioner Margaret Hamburg placed special emphasis on the regulatory science priority in an introduction to the document.

Advancing Regulatory Science

FDA says it will create and execute a strategic plan for expanding and modernizing the field of regulatory science at the agency and across the country.

"We must develop the appropriate standards and guidance for making approval decisions," the strategic priorities report states.

FDA says better science, tools and standards will make product reviews more accurate and efficient, reducing post-market safety problems and speeding time to market for new technologies.

The regulatory science initiative will help FDA set standards for products that address unmet public health needs and could usher in new developments in personalized medicine, stem-cell therapies and genetic diagnostics, FDA says.

One of FDA's "signature initiatives" involves researching, developing and validating new approaches and tools for identifying the consumer risks and benefits of medical products and foods.

FDA will work with its National Center for Toxicological Research to validate biomarkers to help identify product risks and benefits, and NCTR will help train FDA scientists.

The agency has also created strategies to recruit and retain better scientists, the report says.

Commissioner Hamburg has said she sees a role for industry involvement in strengthening regulatory science at the agency (¹ Also see "FDA Commissioner Sees Industry Role In Regulatory Science Initiative" - Medtech Insight, 28 June, 2010.).

Compliance, Enforcement Projects

FDA also underlines its commitment to strengthen regulatory compliance and enforcement activities.

"The agency must act swiftly and aggressively to guarantee effective enforcement," the report states, echoing the stern warning Commissioner Hamburg gave shortly upon taking the helm of the agency in May 2009 (² Also see "FDA's New Enforcement Approach Will Put More Warning Letters In The Mail" - Medtech Insight, 10 August, 2009.).

In addition to the enforcement initiatives that FDA has launched over the past year, the agency will also begin implementing processes to prioritize follow-up inspections after FDA has issued a warning letter, classified a major recall or taken other enforcement actions, the report says.

FDA will also work more closely with its field offices, local and state regulatory authorities, and foreign governments to share more laboratory and enforcement data.

"When regulatory and enforcement partners are able to act more quickly than FDA, FDA will collaborate with them and encourage them to take the immediate action in response to violations," the report explains.

Special Needs Populations

Over the next five years, the agency also plans to increase its push to spur development of products for women, children, minorities and other under-served populations.

"Much work remains to be done" in meeting the needs of under-served populations, FDA states.

For pediatrics, "we need to develop validated endpoints for neonates if we are to treat this vulnerable population with knowledge instead of guesses," the report states.

FDA will also continue to explore why many products work in adults but not children, and study the long-term safety of devices and other medical products used chronically in children.

This year, FDA plans to create a new Office of Minority Health to help reduce health disparities in the U.S., according to the report.

Device Priorities: Transparency And Innovation

For medical devices in particular, FDA will focus on projects that improve the consistency of regulatory decision-making and spur innovative device development.

A "major component" of FDA's strategy to strengthen its pre-market review programs is the ongoing review of the 510(k) pre-market notification program, the report says.

For devices, FDA will also build on several other recently launched initiatives within the device center, including the Council on Medical Device Innovation, which met for the first time in June, and includes representatives from NIH, CMS and other government agencies.

"The government may be able to do more to encourage the development of new devices, especially for unmet medical needs," the report states.

Comments on the strategic report are due Nov. 1.

- Jessica Bylander ( ³ j.bylander@elsevier.com )

FDA Outlines Priorities For Next Five Years In Strategic Report

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