This website covers knowledge management, personal effectiveness, theory of constraints, amongst other topics. Opinions expressed here are strictly those of the owner, Jack Vinson, and those of the commenters.

New FDA Strategy

Mark McClellan, the FDA's new director has released his strategic vision for the agency. FDA: Strategic Plan Advancing America's Health

We are moving toward a science-based, "life cycle" approach to assuring the safety of food products. This approach, also based on the principles of efficient risk management, will enable us to achieve the greatest food protection with our limited resources. For example, when it comes to bulk imports, instead of a taking a snapshot at the border by examining and sampling a particular shipment, we're trying to get a broader picture that covers the product's history from raw materials, through production, transportation to the U.S. manufacturer or producer if there is one, storage, and to the ultimate consumer.


This quote highlights the FDA's desire to take advantage of the latest science and management principles to assure public safety and help pharmaceutical companies improve their ability to get drugs to market.

The areas discussed in the report are

  • Efficient Risk Management
  • Empowering Consumers: Improving Healthcare through Better Information
  • Improving Patient and Consumer Safety
  • Protecting America from Terrorism
  • Smarter Regulation through a Stronger Workforce

I am interested in the first entry, Efficient Risk Management. The report lists a number of major topics with a good discussion of the current practice and the changes that the FDA sees as being an appropriate combination of new science and better risk management. (Parenthesis are my interpretation and comments.)

  • Efficient Risk Management: The Most Public Health Bang for our Regulatory Buck
  • Enforcement: Targeting Limited Resources for Maximum Protection. (Using a smarter approach to enforce regulations, including better information technology approaches that help identify "problem" areas.)
  • New Drug Development: A Need for Greater Productivity. (Mentions the $800 million, 10+ years to develop drugs of a Tufts study - pdf. Others are now quoting higher numbers, such as $1.2 - 1.4 billion mentioned by Wyeth president, Robert Ruffolo, Jr.)
  • Manufacturing: Need for Greater Flexibility and Efficiency. (Mentions making it easier to implement continuous improvement programs in pharma manufacturing. Traditionally, regulatory hurdles discourage significant process changes, once a product has been approved.)
  • Imports: Need for Safety Oversight to Catch Up to Quantum Growth in Volume of Entries
  • Foods: Food borne Disease remains a Major Public Health Threat

The report identifies four objectives and strategies under this goal for efficient risk management.

  1. Provide timely, high quality, cost-effective process for review of new technologies/pre-market submissions.
  2. Provide high quality, cost-effective oversight of industry manufacturing, processing and distribution to reduce risk.
  3. Assure the safety of the US food and cosmetics supply to protect consumers at the least cost for the public.
  4. Develop methodological strategies and analyses to evaluate options, identify the most effective and efficient risk management strategies, and optimize regulatory decision-making.


National Mole Day

KM at The Law Society