Oxycontin Prosecution

How, in general, does the potential for addiction and recreational use factor into drug approval decisions? Could a drug be denied approval purely because it was seen as being too likely to be diverted for recreational use, or does is the drug's addiction potential only relevant in its legitimate users? In the case of highly addictive drugs that are approved, are there legally binding restrictions(ie. for terminal cases only) or only cautionary labelling?

Growing up in northeastern Kentucky, I can vouch for the appropriateness of the "hillbilly heroin" moniker.

Theoretically, the potential for abuse of a drug is not a factor in approval by the FDA. I say theoretically because I think the FDA has gotten somewhat puritanical lately, but that is a soft opinion, not an established fact.

When a drug is approved, the DEA classifies drugs according to the perception of the potential for abuse. Different restrictions apply to different DEA classifications.

Individual States may impose more stringent restrictions than those required by the DEA.

In general there are no legally binding restrictions regarding use of a drug only in specific circumstances, such as terminal cases. The FDA could theoretically set up such requirements, but I don't think they ever have. They have set up programs a few such programs, such as a program to restrict use of Accutane, such that it is not given to women with childbearing potential. In practice those programs tend to be only partly effective.

The system is kind of messy because the DEA is a part of the Dept. of Justice, so they are a law enforcement agency, not a medical or scientific agency. The FDA is a regulatory agency, but it does employ a lot of scientists and medical personnel. The FDA has almost no enforcement authority.

Individual State boards (of Medicine and Pharmacy) do have regulatory and enforcement authority, but they rarely get involved with making regulations for individual drugs.

According to Barry Meier's book on the subject - he is the NY Times investigative reporter who has been on the Oxycontin beat - the marketers did indeed make the case that Oxycontin was less addictive, or non-addictive, and that it was nearly impossible to abuse because of its time release properties.

Naturally, within months of its release, people had found ways to get around the time release and oxycontin, for all the good it does relieving severe pain for those afflicted, was well on its way to becoming a serious public health hazard.

I didn't get any euphoria. Nor did I get addicted. Of course, I only took it for a few days after my cancer surgery, so I may not have been on it long enough. OTOH, I had no pain.