Off Label Drug Use Marketing

Health & FitnessMedicine

  • Author Greg Edwards
  • Published February 5, 2007
  • Word count 403

When a drug is approved by the FDA for a specific use, pharmaceutical companies are only allowed to market the drug for that use. Any drug may be prescribed by a doctor for any use, including uses not described in the approved labeling. This is considered to be an “off-label” use.

For example, an article in points out, “it is not uncommon for physicians to prescribe low doses of beta blocker drugs to help people overcome jitters before public speaking. Beta blockers are not formally approved for this use. The FDA advises doctors in such circumstances that “they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product's use and effects.”

Off-label drug use has left use with the problem of off-label marketing. Although off label marketing has been deemed illegal by the FDA, that hasn’t stop drug companies from pushing their drugs for uses that haven’t been approved. All it has done is force drug companies to find a more crafty way to solicit their information.

Instead of showing TV commercials advertising the other uses, now they go straight to the source that prescribes their drugs, the doctors. For example, Eli Lilly has recently been accused of marketing its anti-psychotic drug Zyprexa to treat dementia. An exert from an article in Medical New Today; “It has been reported that a US lawyer handling the lawsuits of mentally ill patients is in receipt of internal marketing documents belonging to Eli Lilly that allegedly contain evidence of a longstanding campaign to influence doctors to prescribe Zyprexa for non-approved use, specifically to elderly patients with dementia.”

Drugs do not get tested and do not receive approval for all available uses in order to extend the patent life of a drug. When a patent for exclusive marketing rights for a particular drug run out, the drug company just tests it for another similar use and extends the patent life in order to make more money. The people that get hurt by being prescribed wrongful medication by their doctors who were solicited information for alternative uses by the drug companies are just part of making money.

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