We're unable to sign you in at this time. Please try again in a few minutes.
We were able to sign you in, but your subscription(s) could not be found. Please try again in a few minutes.
There may be a problem with your account. Please contact the AMA Service Center to resolve this issue.
Contact the AMA Service Center:
Telephone: 1 (800) 262-2350 or 1 (312) 670-7827  *   Email: subscriptions@jamanetwork.com
Error Message ......
Commentary |

How the US Drug Safety System Should Be Changed

Brian L. Strom, MD, MPH
JAMA. 2006;295(17):2072-2075. doi:10.1001/jama.295.17.2072.
Text Size: A A A
Published online


Reading a recent newspaper might remind one of the above quote. One of the questions the nation is currently confronted with is what should be done to address the safety of drugs. In this Commentary, the current system of drug safety monitoring will be described and the limitations of the current system will be highlighted. A potential solution will then be proposed that will require legislation to implement.

Corresponding Author: Brian L. Strom, MD, MPH, Department of Biostatistics and Epidemiology, Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, 824 Blockley Hall, 423 Guardian Dr, Philadelphia, PA 19104-6021 (bstrom@cceb.med.upenn.edu).

Financial Disclosures: Dr Strom receives funding from the National Institutes of Health, Agency for Healthcare Research and Quality (including CERT funding, DEcIDE [Developing Evidence to Inform Decisions about Effectiveness] funding, and patient safety funding), has received grants and served as a consultant to most of the major pharmaceutical companies, and is a US Food and Drug Administration (FDA) Special Government Employee for serving on FDA advisory committees. He has served as a consultant to the Joint Commission on Prescription Drug Use, assisting in drafting its report. There was no funding support for the work presented in this article.

Previous Presentation: Presented as an invited talk at the Institute of Medicine Annual Meeting, October 23-24, 2005, Washington, DC.

Figures in this Article


drug safety

Sign in

Purchase Options

• Buy this article
• Subscribe to the journal
• Rent this article ?

First Page Preview

View Large
First page PDF preview


Figure. Alternative Models for Studying Drug Safety
Graphic Jump Location

Top row, historical approach; middle row, where the current system is evolving toward now; and bottom row, proposed approach. Phase 1 indicates dose escalation, usually in healthy study participants; phase 2, dose ranging (usually first time in patients); phase 3, pivotal trials for registration; phase 4, postmarketing (not always required).



Also Meets CME requirements for:
Browse CME for all U.S. States
Accreditation Information
The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 CreditTM.
Note: You must get at least of the answers correct to pass this quiz.
Please click the checkbox indicating that you have read the full article in order to submit your answers.
Your answers have been saved for later.
You have not filled in all the answers to complete this quiz
The following questions were not answered:
Sorry, you have unsuccessfully completed this CME quiz with a score of
The following questions were not answered correctly:
Commitment to Change (optional):
Indicate what change(s) you will implement in your practice, if any, based on this CME course.
Your quiz results:
The filled radio buttons indicate your responses. The preferred responses are highlighted
For CME Course: A Proposed Model for Initial Assessment and Management of Acute Heart Failure Syndromes
Indicate what changes(s) you will implement in your practice, if any, based on this CME course.


Some tools below are only available to our subscribers or users with an online account.

0 Citations

Sign in

Purchase Options

• Buy this article
• Subscribe to the journal
• Rent this article ?

Related Content

Customize your page view by dragging & repositioning the boxes below.

Articles Related By Topic
Related Collections
PubMed Articles