Featured Research

from universities, journals, and other organizations

Off-label marketing of medicines in the US is rife but difficult to control, study finds

Date:
April 6, 2011
Source:
Public Library of Science
Summary:
Despite U.S. Federal Drug Administration regulation of the approval and use of pharmaceutical products, "off-label" marketing of drugs (for purposes other than those for which the drug was approved) has occurred in all aspects of the US health care system. In a new study, researchers report that the most common alleged off-label marketing practices also appear to be the most difficult to control through external regulatory approaches.

Despite Federal Drug Administration regulation of the approval and use of pharmaceutical products, "off-label" marketing of drugs (for purposes other than those for which the drug was approved) has occurred in all aspects of the US health care system. In a study published in this week's PLoS Medicine, Aaron S. Kesselheim from Brigham and Women's Hospital, Boston, USA and colleagues report that the most common alleged off-label marketing practices also appear to be the most difficult to control through external regulatory approaches.

They identified three main goals of alleged off-label marketing programs: expansion of drug use to unapproved diseases, expansion to unapproved disease subtypes, and expansion to unapproved drug dosing strategies, typically higher doses.

In their study, the authors classified the strategies and practices used in off-label marketing by examining 41 complaints filed by whistleblowers related to 18 alleged cases of off-label marketing in federal fraud cases that were settled or unsealed between January 2004 and October 2010. These findings provide a snapshot of off-label marketing strategies and practices allegedly employed in the US, and this analysis may help to develop new and effective regulatory strategies.

All of the whistleblowers alleged prescriber-related practices (including providing financial incentives and free samples to physicians), and most alleged internal practices intended to bolster off-label marketing, such as sales quotas that could only be met if the manufacturer's sales representatives promoted off-label drug use. Payer-related practices (for example, discussions with prescribers about ways to ensure insurance reimbursement for off-label prescriptions) and consumer-related practices (most commonly, the review of confidential patient charts to identify consumers who could be off-label users) were also alleged. However, these practices were alleged by whistleblowers in cases intervened by the US Department of Justice, and were not the subject of testimony in a full trial; thus, some of the practices identified by the researchers could not be confirmed.

The authors say: "Off-label marketing has been ubiquitous in the health care system and features some behaviors and strategies that may be resistant to external regulatory approaches."

They continue: "Aside from sales representatives and other company insiders, who play important roles as whistleblowers, physicians are alone in having a full view of many of the most insidious forms of illegal marketing outlined in the complaints we reviewed. As physicians' understanding of these practices and the consequences of inappropriate off-label promotion for public health evolves, so may their enthusiasm for shutting them down."


Story Source:

The above story is based on materials provided by Public Library of Science. Note: Materials may be edited for content and length.


Journal Reference:

  1. Aaron S. Kesselheim, Michelle M. Mello, David M. Studdert. Strategies and Practices in Off-Label Marketing of Pharmaceuticals: A Retrospective Analysis of Whistleblower Complaints. PLoS Medicine, 2011; 8 (4): e1000431 DOI: 10.1371/journal.pmed.1000431

Cite This Page:

Public Library of Science. "Off-label marketing of medicines in the US is rife but difficult to control, study finds." ScienceDaily. ScienceDaily, 6 April 2011. <www.sciencedaily.com/releases/2011/04/110405174843.htm>.
Public Library of Science. (2011, April 6). Off-label marketing of medicines in the US is rife but difficult to control, study finds. ScienceDaily. Retrieved August 21, 2014 from www.sciencedaily.com/releases/2011/04/110405174843.htm
Public Library of Science. "Off-label marketing of medicines in the US is rife but difficult to control, study finds." ScienceDaily. www.sciencedaily.com/releases/2011/04/110405174843.htm (accessed August 21, 2014).

Share This




More Health & Medicine News

Thursday, August 21, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Possible Ebola Patient in Isolation at California Hospital

Possible Ebola Patient in Isolation at California Hospital

Reuters - US Online Video (Aug. 20, 2014) — A patient who may have been exposed to the Ebola virus is in isolation at the Kaiser Permanente South Sacramento Medical Center. Linda So reports. Video provided by Reuters
Powered by NewsLook.com
Raw: World's Oldest Man Lives in Japan

Raw: World's Oldest Man Lives in Japan

AP (Aug. 20, 2014) — A 111-year-old Japanese was certified as the world's oldest man by Guinness World Records on Wednesday. Sakari Momoi, a native of Fukushima in northern Japan, was given a certificate at a hospital in Tokyo. (Aug. 20) Video provided by AP
Powered by NewsLook.com
Do More Wedding Guests Make A Happier Marriage?

Do More Wedding Guests Make A Happier Marriage?

Newsy (Aug. 20, 2014) — A new study found couples who had at least 150 guests at their weddings were more likely to report being happy in their marriages. Video provided by Newsy
Powered by NewsLook.com
Ebola-Hit Sierra Leone's Freetown a City on Edge

Ebola-Hit Sierra Leone's Freetown a City on Edge

AFP (Aug. 19, 2014) — Residents of Sierra Leone's capital voice their fears as the Ebola virus sweeps through west Africa. Duration: 00:56 Video provided by AFP
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
 
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:  

Breaking News:
from the past week

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:  

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile iPhone Android Web
Follow Facebook Twitter Google+
Subscribe RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins