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Q: How does the US government decide whether to schedule a new drug? Who decides "abuse liability"?

A: The simple answer is that every new drug is evaluated by the Food and Drug Administration (FDA) for whether it can get you "high" in a fashion that is similar to other known drugs.

In 2010, the FDA first published a draft decision tree showing how they look at new drugs. For drugs that are approved through the FDA process, which can take years and costs tens or hundreds of millions of dollars, the FDA requires multiple data types.

Every new drugs requires basic pharmacology information and in vitro testing. Any new drug that has similar theoretical or in vitro pharmacology to an existing controlled substance has to be evaluated through animal and human testing to determine whether it might get someone "high". The concept is very general and the FDA and the DEA lean towards controlling substances that anyone might use recreationally (ie enjoy).

The current primary documentation of this decision-making process:

FDA's 2011 Decision-Making Tree for Assessment of Abuse Potential

Slide Presentation about the FDA's 2011 Abuse Liability Decision-Making Tree

Draft description of the FDA's Abuse Liability Determination Process

The current scheduling regime under the 1970/71 Controlled Substances Act pretty much makes any new drug that has pleasant, enjoyable, fun effects illegal for possession without a prescription. Even drugs that aren't fun but which have effects that a substantial number of people might use without a doctor's permission will get controlled, such as steroids that can help people build muscle or lose weight.

Asked By : ims
Answered By : earth
Edited By : fire
Published Date : 1 / 13 / 2014
Last Edited Date : 1 / 13 / 2014
Question ID : 3182

Categories: [ Law ] [ General ]



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