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FDA Strategic Plan

By September 6, 2011Commentary

Much of the growth in health care spending is alleged to be due to new technologies, most of which take the form of drugs, medical devices and medical equipment.  The Food & Drug Administration is the primary regulator for these items and therefore its work and policies can have an effect on spending.  If the FDA moves quickly and easily approves items, spending can increase more rapidly.  If the FDA begins to expand approval requirements and move more slowly, new technologies will be slower to reach the market and will not affect spending as quickly.  The agency recently released its strategic plan for advancing regulatory science.   (FDA Plan) The plan is organized around priority areas and sets out high level implementation strategies for each of those areas.

The plan identifies eight priority areas, including modernizing toxicology; stimulating innovation in personalized medicine; support new approaches to product manufacturing and quality; ensure readiness to evaluate innovate emerging technologies; harness data to improve health outcomes; facilitate countermeasures for bioterrorism and strengthen social and behavioral science to help consumers and providers make informed decisions about medical products.   Some of the specific implementation issues include greater use of biomarkers and companion diagnostics to help identify patients who are most likely to benefit from a product and to assist in avoiding adverse events and the development of new clinical trial and development strategies to speed innovative products to market while ensuring real-life information is gathered on the product’s effects.  Perhaps the most fascinating area is harnessing what economics and psychology are learning about human cognition and consumer behavior.  That is a key part of patient self-management of health and health care.

The FDA has a difficult job, battered by consumer advocates for lax safety and efficacy regulation and by the industry it governs for being expensive and slow.  It tends to wobble around a middle path over time; as safety issues come up it gets tougher and when industry screams that it is impeding innovation it tries to move more quickly.  Like all federal agencies it is beset by bureaucracy, often mediocre employees who can’t work elsewhere, high turnover of good staff and other issues common to any large organization.  Overall, it has done a fairly good job and it certainly has identified the areas on which it needs to focus for the future.  The medical products industry has been a huge contributor to US economic and jobs growth, but also a major source of excessive spending.  The real regulatory problem is how to balance those two issues.

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