What is the relationship between DEA and the Food and Drug Administration (FDA) in regulating drugs like OxyContin® ?
The FDA is responsible for approving drugs for medical use. These drugs include those sold over-the-counter, those requiring a prescription, and prescription drugs that are controlled under the CSA. The FDA also sets regulations for the marketing of drugs, including controlled substances. DEA does not directly regulate the marketing of controlled substances. However, in keeping with DEA’s mandate to ensure appropriate safeguards against diversion, DEA is concerned when marketing and advertising tactics appear to create an increased possibility for diversion or misuse. If marketing tactics seem to lead to oversupply or minimize the abuse potential of a controlled substance, the DEA makes every effort to work with pharmaceutical companies and the FDA to find appropriate solutions to these problems.
