The biotech is actually restricting Avastin sales now to cut down on unapproved use.
In fact, the biggest blow to what doctors say is evidence of unapproved use of Natrecor.
Unapproved use is at best worrying and unfair, and at worst dangerous and immoral.
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Most Natrecor sales at one point came from an unapproved use: Hoping to help less sick patients, doctors were giving it in clinics.
And last August GSK settled a suit filed by New York Attorney General Eliot Spitzer, who accused the company of failing to publish negative studies about unapproved use of its antidepressant Paxil.
While the FDA can warn against the unsafe use of a medical device, doctors are not prohibited from using cleared or approved devices for an unapproved use within their practice of medicine.
The problem for regulators, though, is that interactions between drug company sales representatives and doctors occur behind closed doors--and just because a doctor is prescribing a medicine for an unapproved use doesn't mean the drug firm suggested that he do so.
As Roderick Long points out, some of those decrying intemperate rhetoric want to restrict it by (non-ironically) threatening real, non-metaphorical violence against those who use unapproved metaphors and imagery.
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These sleepy-sounding piles of paperwork allow the FDA to compel manufacturers to distribute medication guides warning of potential risks, to force doctors to attest that a patient really needs a drug, and even to distribute medicines through specialized pharmacies to prevent unapproved uses or illicit use.
To the extent the goal of the hot line is to extend the use of the drug into these unapproved uses, I think that is something I'm quite opposed to.
Governments concerned that their citizens might use satellite-TV dishes to view unapproved programmes or web sites can take heart from Sky Global Networks' filings with America's Securities and Exchange Commission.
In July Glaxo pled guilty to U.S. misdemeanor charges that it had marketed the anti-depressants Paxil and Wellbutrin for unapproved uses and had not disclosed clinical data related to the diabetes medicine Avandia, which eventually had its use severely restricted because it may increase the risk of heart attacks.
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