Featured Research

from universities, journals, and other organizations

FDA Plans To Reduce Oversight Of Off-label Drug Use Criticized By Medical Researchers

Date:
April 6, 2008
Source:
Stanford University Medical Center
Summary:
Proposed guidelines from the US Food and Drug Administration would allow companies to market more drugs for unapproved uses and are a step in the wrong direction, said a researcher from the Stanford University School of Medicine.

Proposed guidelines from the U.S. Food and Drug Administration would allow companies to market more drugs for unapproved uses and are a step in the wrong direction, said a researcher from the Stanford University School of Medicine.

Related Articles


In an editorial to be published in the April 3 issue of The New England Journal of Medicine, Randall Stafford, MD, PhD, associate professor of medicine at the Stanford Prevention Research Center, criticized the draft guidelines, which are subject to public comment through April 21. They curtail the FDA's already limited authority over the marketing of drugs for off-label uses, Stafford said.

While most people assume that the medicines prescribed by doctors in the United States have the FDA's stamp of approval, that's only partially true. The FDA approves drugs for specific purposes, but doctors can use drugs "off-label" for medical conditions not approved by the FDA.

Off-label prescribing for medical conditions not scrutinized during the FDA approval process is common. There's nothing illegal about off-label prescribing, and in many cases it's good medicine, said Stafford, who directs Stanford's Program on Prevention Outcomes and Practices. As long as the FDA has approved a drug for one condition, physicians are free to prescribe it for anything.

Unfortunately, what's known about the use of a drug for one situation may not apply to other clinical scenarios. Stafford pointed to the use of antidepressants in children and the use of antipsychotic medications for dementia as key examples.

"The FDA should not suddenly start telling physicians how to practice. Physician judgment is critical, especially when approved therapies have not succeeded. Off-label prescribing can be an important tool in such cases," he said. "But in other cases, off-label prescribing has become first-line therapy even in the absence of strong evidence of benefits and safety. This is problematic."

Stafford said these types of situations suggest the need for a better way to evaluate and regulate off-label drug use. Ideally, he said, a drug company would go back to the FDA with additional clinical studies and obtain supplemental approval for a new clinical use.

Off-label drug use is already common, but applications to the FDA for approval of new uses are uncommon, said Stafford. This process may be seen as irrelevant by drug manufacturers, who have strategies for expanding their off-label markets and boosting drug sales without formal FDA approval.

Although FDA regulations restrict drug manufacturers from overtly promoting their drugs for unapproved conditions, they are free to share educational materials with physicians, most often as published journal articles. According to current FDA guidelines, this practice is acceptable, but only if the manufacturer submits the articles to the FDA for review and is pursuing formal FDA approval for the new use. In reality, however, FDA enforcement is limited, said Stafford.

The new draft guidelines further pull back FDA involvement by eliminating both of these requirements. In addition, they reduce the remaining policies to non-binding recommendations.

This concerned Stafford, who wrote in the NEJM editorial: "The FDA may be conceding to drug manufacturers the responsibility for regulating their own off-label marketing practices. The agency may also believe that its limited resources can be put to better or more effective use in confronting other ongoing challenges. Nevertheless, I believe that the FDA must take an active role in fostering evidence-based practice, eliminating subversion of the approval process, and requiring a balanced and fair presentation of the scientific evidence."

One of the proposed guidelines' major pitfalls, said Stafford, would be allowing drug manufacturers to skip obtaining approval for potentially lucrative drug uses. Instead, companies might seek approval only for a narrower use that's more easily and less expensively tested, and sponsor research on more commercially promising uses that are never evaluated by the FDA. Stafford warned that this might encourage widespread treatment of conditions with drugs never approved by the FDA for those purposes.

Off-label use is already burgeoning. In a 2006 examination of off-label prescribing of 160 common drugs, Stafford found that off-label use accounted for 21 percent of all prescriptions and 73 percent of these uses had little or no scientific support (Archives of Internal Medicine, May 8, 2006). Drugs approved for depression, schizophrenia and seizures were most likely to be used off-label without adequate support for other conditions.

The FDA is accepting comments on the draft guidelines through April 21. Comments can be made online at http://regulations.gov, search for the docket "FDA-2008-D-0053" and use the "send a comment" option.


Story Source:

The above story is based on materials provided by Stanford University Medical Center. Note: Materials may be edited for content and length.


Cite This Page:

Stanford University Medical Center. "FDA Plans To Reduce Oversight Of Off-label Drug Use Criticized By Medical Researchers." ScienceDaily. ScienceDaily, 6 April 2008. <www.sciencedaily.com/releases/2008/04/080402181245.htm>.
Stanford University Medical Center. (2008, April 6). FDA Plans To Reduce Oversight Of Off-label Drug Use Criticized By Medical Researchers. ScienceDaily. Retrieved November 22, 2014 from www.sciencedaily.com/releases/2008/04/080402181245.htm
Stanford University Medical Center. "FDA Plans To Reduce Oversight Of Off-label Drug Use Criticized By Medical Researchers." ScienceDaily. www.sciencedaily.com/releases/2008/04/080402181245.htm (accessed November 22, 2014).

Share This


More From ScienceDaily



More Health & Medicine News

Saturday, November 22, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

WFP: Ebola Risks Heightened Among Women Throughout Africa

WFP: Ebola Risks Heightened Among Women Throughout Africa

AFP (Nov. 21, 2014) Having children has always been a frightening prospect in Sierra Leone, the world's most dangerous place to give birth, but Ebola has presented an alarming new threat for expectant mothers. Duration: 00:37 Video provided by AFP
Powered by NewsLook.com
Could Your Genes Be The Reason You're Single?

Could Your Genes Be The Reason You're Single?

Newsy (Nov. 21, 2014) Researchers in Beijing discovered a gene called 5-HTA1, and carriers are reportedly 20 percent more likely to be single. Video provided by Newsy
Powered by NewsLook.com
Milestone Birthdays Can Bring Existential Crisis, Study Says

Milestone Birthdays Can Bring Existential Crisis, Study Says

Newsy (Nov. 21, 2014) Researchers find that as people approach new decades in their lives they make bigger life decisions. Video provided by Newsy
Powered by NewsLook.com
Ebola: Life Without School in Guinea

Ebola: Life Without School in Guinea

AFP (Nov. 21, 2014) Following the closure of schools and universities in Guinea because of the Ebola virus, students look for temporary work or gather in makeshift classrooms to catch up on their syllabus. Duration: 02:14 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:

Strange & Offbeat Stories


Health & Medicine

Mind & Brain

Living & Well

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