0
Special Communication |

The Safety of Newly Approved Medicines:  Do Recent Market Removals Mean There Is a Problem?

Michael A. Friedman, MD; Janet Woodcock, MD; Murray M. Lumpkin, MD; Jeffrey E. Shuren, MD, JD; Arthur E. Hass; Larry J. Thompson, MS
JAMA. 1999;281(18):1728-1734. doi:10.1001/jama.281.18.1728.
Text Size: A A A
Published online

The removal of 5 pharmaceuticals from the market in a 12-month period because of unexpected adverse events raised concerns about the adequacy of the drug review process at the US Food and Drug Administration (FDA). Specifically, concerns were raised about improvements in drug review efficiency that significantly reduced FDA review times. We have reviewed the circumstances of the 5 removals to determine whether there was any relationship to the increased efficiencies in the drug review process. When the removed drugs were analyzed by date of approval, no increase in the number of drugs taken off the market was seen, demonstrating that reduced review processing time was not the reason for the cluster of removals. We conclude that the agency's drug review procedures and postmarketing surveillance system after a drug has been marketed are currently adequate but must continually adjust to future challenges.

Figures in this Article

Sign In to Access Full Content

Don't have Access?

Register and get free email Table of Contents alerts, saved searches, PowerPoint downloads, CME quizzes, and more

Subscribe for full-text access to content from 1998 forward and a host of useful features

Activate your current subscription (AMA members and current subscribers)

Purchase Online Access to this article for 24 hours

Figures

Figure 1. Distribution of Withdrawn Pharmaceuticals by Year of Withdrawal
Graphic Jump Location
Figure 2. Distribution of Withdrawn Pharmaceuticals by Year of Approval
Graphic Jump Location
Figure 3. Twenty-Year Trends in New Drug and New Molecular Entities Approval
Graphic Jump Location
Figure 4. Rate of Withdrawal of New Molecular Entities
Graphic Jump Location
The trend and differences are not statistically significant. Earlier approval cohorts have had a longer time during which withdrawals could occur, so that future withdrawals from these approval cohorts could alter these results.
Figure 5. Percentage of New Molecular Entities Reaching the US Market
Graphic Jump Location
The percentage of new molecular entities introduced in the United States before introduction in any other country has risen steadily over the last 2 decades.

Tables

References

CME
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.
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.
NOTE:
Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s "Cited By" API will populate this tab (http://www.crossref.org/citedby.html).

Multimedia

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

Web of Science® Times Cited: 128

Sign In to Access Full Content

Related Content

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

Articles Related By Topic
Related Topics
PubMed Articles
Jobs
brightcove.createExperiences();