FDA, and acceptance of changes intended to strengthen drug safety. FDA’s credibility is intertwined with that of the industry, and a more credible drug safety system is in everyone’s best interest. For the health care delivery system, a lifecycle approach to risk and benefit implies the need to heed and follow FDA communication about drug safety matters and to exercise appropriate caution in drug-related decision making (from formularies to prescribing) in recognition of the limited information available at the time of drug approval. The health care delivery system will benefit by consistently basing prescribing decisions on the science, and by exercising caution in regard to the industry’s influence on the practice of medicine. Health care organizations and professional societies can contribute to prescribers’ understanding of the evolving science behind the assessment of drug risk and benefit. The academic research enterprise can enhance its contributions of data to the assessment of risk and benefit at all points in a drug’s lifecycle, continue its crucial advisory relationship with FDA, and uphold the value of complete transparency in recognition of real and perceived conflicts associated with financial involvement with the industry. Other government agencies can contribute to the lifecycle approach to drug risk and benefit by collaborating with FDA and the private sector to ensure that data streams from publicly funded health care settings contribute to an improved drug safety system. The public and patients can do their part by communicating with their health care providers about the pharmaceutical products they are using, learning about and discussing with their providers a drug’s risks and benefits in the context of their health needs and characteristics, informing their providers about side effects they experience, and calling for more useful and timelier information about drug benefits and risks associated with new drugs.

REFERENCES

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CDER (Center for Drug Evaluation and Research). 1998. Guideline for the Format and Content of the Clinical and Statistical Sections of an Application. Rockville, MD: CDER.

Cockburn IM. 2004. The changing structure of the pharmaceutical industry. Health Aff (Mill-wood) 23(1):10-22.

DHEW (Department of Health Review Panel on New Drug Regulation), Dorsen N, Weiner N, Astin AV, Cohen MN, Cornelius CE, Hamilton RW, Rall DP. 1977. Final Report. Washington, DC: DHEW.

DHHS (Department of Health and Human Services), FDA, Task Force on Risk Management. 1999. Managing the Risks from Medical Product Use: Creating a Risk Management Framework. [Online]. Available: http://www.fda.gov/oc/tfrm/riskmanagement.pdf [accessed October 10, 2005].



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