FDA to Promote Life Cycle Protections

On December 8, the new Food and Drug Administration Commissioner, Margaret Hamburg, MD, told the National Health Council, which includes CHADD, that the FDA will be tracking and responding to a "life cycle" approach to medication treatment. Rather than approve medications for sale on the market after approved clinical trials and waiting for adverse reactions to be reported, the FDA (pending additional resources by Congress) plans to track medications over the course of a lifetime (termed "life cycle" tracking).

CHADD and roughly 50 other voluntary health agencies (VHAs) are members of the National Health Council. VHAs are organizations governed by unpaid volunteers, who raise memberships and donations from the public, and are focused on diseases, disabilities, and disorders. Dr. Hamburg was the featured speaker at the NHC December 8 annual meeting.

Dr. Hamburg emphasized the public health protection role of the FDA—anticipating public health change and modifying the FDA regulatory approach. She stressed the need for "personalized medicine," recognizing that while the great mass of the population will do well with a medication, the FDA must do a more effective job of identifying and then regulating adverse medication reactions by small subsets of the population. Part of this approach is to better identify at-risk populations.

The commissioner emphasized protection of food and nutrition and a more aggressive approach to regulating tobacco. She did not mention dietary supplements, other than eliminating hazardous supplements. I still hope that Congress one day will give the FDA the legal authority to regulate the quality and integrity of diet supplement ingredients and the legal authority to substantiate diet supplement claims. Many diet supplement manufacturers and distributors make unsubstantiated claims regarding the healing nature of such products for a variety of learning, developmental, and mental disorders. My family uses dietary supplements and we think they are helpful, but desire an objective third party to substantiate claims and integrity.

It is nice and reassuring to hear the new FDA commissioner thinking about a more proactive consumer and family protection focus. It was nice to see the FDA commissioner interested in communicating with roughly 50 national VHAs.

Clarke

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