The labeling change encourages healthcare providers to use genetic tests before prescribing warfarin. The agency believes
the tests would help physicians better determine the reasonable warfarin dose for individual patients, optimize the use of
warfarin, and lower the risk of bleeding complications from the drug. The labeling changes result from an analysis of recent
studies that found that certain genetic variations influence the way people respond to the drug.
"Today's approved labeling change is one step in our commitment to personalized medicine. By using modern science to get the
right drug in the right dose for the right patient, FDA will further enhance the safety and effectiveness of the medicines
Americans depend on," FDA Commissioner Andrew C. von Eschenbach said in an agency press release. The agency's personalized
medicine initiative is based on pharmacogenomics, the science that predicts a response to drugs based upon a person's genetic
makeup. –Erik Greb
Working Group Releases Strategy to Ensure Import Safety
The US Food and Drug Administration's Interagency Working Group on Import Safety released a Strategic Framework on Sept. 10,
based on a cost-effective, risk-based approach for ensuring the safety of products exported to the United States. Instead
of assessing products at the border, the strategy recommends examining products' entire life cycles. The strategy requires
cooperation with foreign manufacturers to identify and mitigate risk during crucial parts of the production and distribution
The Strategic Framework follows several months of scandals involving contaminated products manufactured in China. The problems
prompted the US government to send a fact-finding team to China to address concerns about food and drug safety.
The Working Group aims to achieve continuous improvement in import safety by using the following six building blocks:
- Advance a common vision
- Increase accountability, enforcement, and deterrence
- Focus on risk over the life cycle of an imported product
- Build interoperable systems
- Foster a culture of collaboration
- Promote technological innovation and new science.
The building blocks recommend changes to the oversight process, including shared goals among federal agencies that promote
import safety, better communication between parties in the global supply chain, and collaboration between government and industry.
The Framework says FDA has made 34 confidential arrangements with agencies in 17 countries to share approval, inspection,
adverse-event, and emergency information about products manufactured in a partners' territories. FDA currently has more than
two such exchanges each day.
In a public statement, FDA Commissioner Andrew von Eschenbach strongly endorsed the Strategic Framework, commending Health
and Human Services Secretary Michael Leavitt for leading the Working Group and developing the Framework. President Bush established
the Working Group in July to develop better ways to work with importers, manufacturers, and other governments to ensure the
safety of imported products. -Erik Greb
FDA Proposes Study of DTC Advertising
The US Food and Drug Administration is seeking public comments on a study designed to investigate the impact of visual distraction
and the interplay of different sensory modalities (e.g., verbal, visual) used to present risk and benefit information during
a television prescription-drug advertisement. Data from this study will provide useful information to help improve how broadcast
ads present a prescription drug's risks and benefits. Notice of the study was published in Federal Register 72 (162), 47051–47053 on Aug. 22.
The purpose of the proposed study is, in part, to determine whether the use of competing, compelling visual information about
potential drug benefits interferes with viewers' processing and comprehension of risk information about drugs in direct-to-consumer
(DTC) advertising or with their cognitive representations of the drugs, according to the notice. "Positive visual images could
influence the processing of risk-related information and the final representation of the advertised drug in multiple ways,"
says the notice.