Data from the US Military Health System related to the review and use of FDA-regulated drugs, biologics and medical devices will be shared with the FDA to help safety reviews.
An FDA news release says general patient data such as prescriptions, lab results and patient weight will be used by FDA to spot trends that may identify potential concerns and recognize product benefits. The two organizations committed to protecting all personal health information exchanged under their partnership agreement.
The partnership is part of the FDA’s Sentinel Network that is intended to explore linking private sector and public sector information to create an integrated electronic network. Among the DoD programs involved in the agreement is Tricare, the agency that administers the healthcare plan serving 9.1 million members of the uniformed services, retirees, and their families. Officials say Tricare Rx information is likely to be the first item shared.
Officials from the FDA and the DoD will meet later this year to establish guidelines.
From the October 01, 2007 Issue of MM+M - Medical Marketing and Media
