That temptation must be even worse for small firms whose prospects are tied to the approval of a single unapproved drug.

FORBES: Magazine Article

In February the FDA warned POM it was marketing its juice as an unapproved drug and demanded it tone down its sales pitch.

FORBES: Magazine Article

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.

FORBES: Cardiologist Calls For Limits On J&J Drug

Instead, doctors found that Neurontin helped with many other ailments, particularly pain caused by nerve damage due to conditions like shingles and diabetes. (This is called neuropathic pain.) That put Warner-Lambert in a bind, because it could not promote the drug for these unapproved uses.

FORBES

While experts say the U.S. drug supply remains safe, unapproved drugs can enter through purchases from Internet pharmacies or unauthorized suppliers.

WSJ: Fakes Infiltrate Injectable Drugs

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.

FORBES: When Doctors Go Off-Label

The drug giant admitted promoting two antidepressant drugs for unapproved uses, including treatment of children and adolescents.

BBC: GlaxoSmithKline launches Africa charity partnership

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.

FORBES: The End Of Drug Withdrawals?

"The recent counterfeit incidents highlight vulnerabilities in the drug-supply chain and the possible health risk to patients if medical practices are choosing to buy unapproved drugs from a foreign supplier, " FDA spokeswoman Sarah Clark-Lynn said in an email.

WSJ: How Fake Avastin Penetrated U.S. Doctors' Offices