Challenges in the Federal Regulation of Pain Management Technologies

Extract

Both the Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA) play a role in regulating pain management technologies, including pharmaceutical products and medical devices indicated for analgesic use. Yet, as things stand, these two key federal entities, with their distinctly different missions and cultures, contribute to the persistent undertreatment of pain through both overregulation and duplicative regulation. The solution lies in refining pain regulation so that a better balance is created between the need to ensure patient access to pain relief and the need to prevent and reduce drug diversion.

Various federal regulatory mechanisms — such as limits on supplies and distribution channels — have created barriers that ultimately affect access to pain management technologies for legitimate users. As the FDA and DEA focus their attention on the misuse of legitimate pain technologies, patients ultimately may be deprived of valuable analgesic agents.