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FDA faulted over unapproved uses of medications (AP)

                   
yahoo.com
Jul 27, 2008
        
Story Timeline:  77 days

By RICARDO ALONSO-ZALDIVAR, Associated Press Writer 12 minutes ago WASHINGTON - When federal regulators catch a drug company peddling prescription medications for an unapproved use, it takes them an average of seven months to issue a warning, according to a draft report by congressional investigators. It typically takes four more months for the company to fix the problem. During that time, a lot prescriptions can be written. The report from the Government Accountability Office delves into a gray area of medical practice and federal oversight: the use of medications to treat conditions other than the ones the drugs were approved for, a practice known as "off-label" prescribing. Although widely accepted, off-label prescribing can amount to an uncontrolled experiment. While some patients benefit, others get drugs that do not do... [read full story]                    

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Lawmakers Call for FDA Overhaul

 wsj.com Jul 30, 2008
First article on this story:

FDA faulted over unapproved uses of medications

 nwsource.com Jul 27, 2008
Selected publications with coverage of this story:
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Found 40 documents:
                   

Lawmakers Call for FDA Overhaul

wsj.com
Jul 30, 2008
        

Broader Authority Would Let Agency Tackle Crises Faster WASHINGTON -- Leading the drive are Rep. John Dingell (D., Mich.) and his longtime friend in Congress, Sen. Chuck Grassley (R., Iowa). A House subcommittee led by Mr....

                   

FDA Poorly Equipped To Enforce Off-Label Prescription Drug Marketing Rules, GAO Report Finds

medicalnewstoday.com
Jul 29, 2008
        

FDA takes an average of seven months to issue warnings to pharmaceutical companies that market medications for off-label uses, and those companies take an average of four months to address the violations, according to a draft...

Marketing of Off-Label Drug Use Called into Question

groundreport.com
Jul 29, 2008
        

Posted by Denis Cummings to findingDulcinea The FDA has been criticized for its plan to allow drug companies to provide doctors with information about a drug’s unintended benefits. In a soon-to-be-released report, the...

                   

FDA Faulted Over Unapproved Uses of Medications

sci-tech-today.com
Jul 29, 2008
        

By Ricardo Alonso-Zaldivar Drug companies are forbidden to promote meds for uses that have not been validated by the FDA. Also, under guidance proposed by the FDA this year, drug companies could distribute to doctors scientific...

                   

FDA poorly equipped to enforce off-label prescription drug marketing rules, GAO report finds

news-medical.net
Jul 29, 2008
        

FDA takes an average of seven months to issue warnings to pharmaceutical companies that market medications for off-label uses, and those companies take an average of four months to address the violations, according to a draft...

Slow Enforcement Of Off-Label Marketing Laws By FDA

furiousseasons.com
Jul 28, 2008
        

A report issued by the General Accounting Office asserts that it takes the FDA seven months to catch instances of off-label marketing by pharma companies and issue a warning to the company and another four months for the...

                   

Drug Ad Rules Are Hazy, Enforcement Often Slow, GAO Reports

truthout.org
Jul 28, 2008
        

Washington - When a state trooper pulls over a speeding motorist, the officer usually writes out a ticket on the spot. When federal regulators catch a drug company peddling prescription medications for an unapproved use, it...

                   

FDA Faulted Over Unapproved Uses of Medications

firstcoastnews.com
Jul 28, 2008
        

WASHINGTON (AP) -- Also, under guidance proposed by the FDA this year, drug companies could distribute to doctors scientific articles that suggest new and unapproved uses for medications. The situation has raised concerns for...

FDA Failing to Monitor Unapproved Uses of Drugs

newsinferno.com
Jul 28, 2008
        

Federal regulators are not doing enough to stop drug makers from promoting unapproved uses of medications, according to a new report. Even when the Food & Drug Administration (FDA) does catch a company promoting a so-called...

                   
pharmalot.com: marketing-for-dummies pharmalot.com

FDA Fails To Pursue Off-Label Violations: Report

pharmalot.com
Jul 28, 2008
        

The FDA takes an average of seven months to issue warnings to drugmakers for off-label marketing, and the drugmakers take an average of four months to address violations, according to the Associated Press, citing a draft report...

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