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 ......
From the Food and Drug Administration |

Proposal Published on Dissemination of Information on Unapproved Uses

Stuart L. Nightingale, MD
JAMA. 1998;280(1):12. doi:10.1001/jama.280.1.12.
Text Size: A A A
Published online


The FDA has published for comment a proposed rule implementing provisions of the Food and Drug Administration Modernization Act of 1997 that, under specific circumstances, permit drug, biologic, and device manufacturers to disseminate written information concerning the safety, effectiveness, or benefits of a use not described in the product's approved labeling. The information would be permitted to be disseminated to health care practitioners, pharmacy benefit managers, health insurance issuers, group health plans, or federal or state government agencies. Before passage of the act, such dissemination could have been considered illegal "promotion" of an unapproved use. The material to be disseminated must first be submitted to FDA for review to see how it will be presented and to determine whether the information is objective and balanced and meets other requirements. The information is to be in the form of unabridged reprints or copies of peer-reviewed articles about scientifically sound clinical investigations published in scientific or medical journals, or in the form of unabridged reference publications pertaining to such investigations. Also, the material is to include the approved labeling and a prominently displayed statement disclosing that the use is not approved by the FDA and, if applicable, a statement that there are products approved for the use. As part of its submission to disseminate information on a particular unapproved use, the manufacturer must certify that it (1) has submitted a supplemental application to the agency for approval of the new use; or (2) has completed the studies needed for such an application and the application will be submitted within 6 months; or (3) has provided the FDA a proposed protocol and schedule for conducting the studies needed for the new use and certifies these will be submitted no later than 36 months after the initial dissemination; or (4) has received an exemption from the requirement to conduct studies. The law provides 2 grounds for exemption from the requirement to conduct studies on the unapproved use: that the necessary studies would be economically prohibitive or that they would be unethical.

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.

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