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 |

Role of the FDA in Affordability of Off-Patent Pharmaceuticals

Jeremy A. Greene, MD, PhD1; Gerard Anderson, PhD2; Joshua M. Sharfstein, MD2
[+] Author Affiliations
1Department of Medicine and Institute of the History of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland
2Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland
JAMA. 2016;315(5):461-462. doi:10.1001/jama.2015.18720.
Text Size: A A A
Published online


This Viewpoint maintains that the US Food and Drug Administration (FDA) should have a more active role in the approval and marketing of off-patent pharmaceutical products.

In recent weeks, the increasing prices of off-patent pharmaceuticals have been the subject of extensive news coverage and debate, a public meeting at the Department of Health and Human Services (HHS), and hearings in both houses of Congress.1 The US Food and Drug Administration (FDA) has not played a central role to date in developing solutions to this challenge. No doubt this reflects the agency’s traditional reluctance to engage with the economic issue of drug pricing. Yet because FDA approves the generic products that establish competitive markets, the agency should have a more active role in ensuring that patients have access to essential drugs that have been affordable for many years.

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.

3 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