Originally Published MX
September/October 2003
EDITOR'S PAGE
FDA Gets a Plan
No matter how much a plan is talked about, there’s nothing like expressing it on the printed page to make it real.
That principle would seem to apply especially well to FDA’s recently announced strategic action plan, Protecting and Advancing America’s Health: Responding to New Challenges and Opportunities. Under development practically since last October’s confirmation of new commissioner Mark B. McClellan, the plan has been the subject of many of the commissioner’s speeches since the beginning of the year. But it was not until the end of this August that the agency finally formalized the plan and made it public.
The new document offers an overview of agency planning and priorities under five headings that have become familiar themes in the commissioner’s speeches:
• Efficient risk management.
• Improving healthcare through better information.
• Improving patient and consumer safety.
• Protecting America from terrorism.
• Smarter regulation through a stronger workforce.
In the cover story of this issue of MX, Commissioner McClellan shares his thoughts about some of the concerns that have given rise to his agency’s new plan. While emphasizing the need for national policies to keep healthcare affordable, McClellan also acknowledges FDA’s responsibility to support the development of innovative medical products.
And along the way, he argues, product review processes that are faster and more efficient will stimulate greater investment in medical technology companies. “Anything we can do to speed up the innovation process—for instance, by clarifying what it takes to get a safe and effective treatment approved, or by making the approval process work more quickly—will both increase the rewards for investment and improve the public health.”
Steve Halasey
Copyright ©2003 MX
