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 ......
Viewpoint |

The Potential Risks of Expedited Approval of Drugs for Acute Bacterial Infections

James S. Floyd, MD, MS1; Bruce M. Psaty, MD, PhD1,2,3,4
[+] Author Affiliations
1Department of Medicine, University of Washington, Seattle
2Department of Health Services, University of Washington, Seattle
3Department of Epidemiology, University of Washington, Seattle
4Group Health Research Institute, Group Health Cooperative, Seattle, Washington
JAMA Intern Med. 2014;174(9):1436-1437. doi:10.1001/jamainternmed.2014.3055.
Text Size: A A A
Published online


Each year, about 23 000 people in the United States die from antibiotic-resistant infections. For many of these infections, safe and effective treatments are lacking. To address this problem, the US Food and Drug Administration (FDA) has updated several expedited approval programs for new antibacterial therapies, some of which alter the evidentiary standard for drug approval.1,2 For instance, a drug may be eligible for “accelerated approval” if it “has an effect on a surrogate end point that is reasonably likely to predict clinical benefit.”2 Since 1992, the accelerated approval program has been available for drugs likely to offer a therapeutic benefit over available treatments for serious or life-threatening diseases. Now, the program’s scope has been expanded to include drugs with marginal ancillary benefits, such as a novel mechanism of action without improvements in safety or efficacy. These well-intentioned new standards for drug approval have increased the risk that the FDA will approve antimicrobial therapies that are less effective or more harmful than available treatments.

Sign in

Purchase Options

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

First Page Preview

View Large
First page PDF preview





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.

1 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.

Related Collections
PubMed Articles