DEA Imposes Extra Layer Of Regulations On Manufacturers Of FDA-Approved Prescription Drugs To Alleviate Pain

Pain therapeutics rank as one of pharmaceutical industry’s key growth sectors, thanks to the “graying” population, scientific advances in understanding the neurological pathways underlying pain perception, and clinicians’ improved awareness of pain management.

Several market research reports have predicted that prescription pain therapeutics could prove to be commercially lucrative to pharmaceutical and biotechnology companies.1 In early 2014, one report predicted that the sales of prescription drugs for pain management would increase over the next four years at a compound annual growth rate of 3.84 percent. According to another market research forecast, the global market for these drugs would reach $60 billion in 2015. In 2010, the global market was estimated at $28.6 billion.

Because prescription pain medications too often have been diverted into the illegal drug trade, development, manufacturing, and distribution are much more complicated for these drugs than for other prescription therapeutics. To produce prescription pain medications in the U.S., manufacturing facilities must abide by the rules and regulations of two federal agencies: the Food and Drug Administration (FDA) and the Drug Enforcement Agency (DEA), an arm of the U.S. Department of Justice that is charged with enforcing the Comprehensive Drug Abuse Prevention and Control Act, better known as the Controlled Substances Act (CSA).

Once a new prescription pain drug is approved by the FDA, DEA in consultation with the U.S. Department of Health and Human Services assigns the medication to one of five categories named Schedule I, II, III, IV, and V. The assignment is based on such factors as the compound’s relative abuse or misuse, safety, its actual or relative potential for being addictive, FDA’s approved medical use of the agent, and scientific evidence about the drug’s pharmacological effect.6 The compounds assigned to Schedule I, II, III, IV, and V are commonly referred to as controlled substances and include not only pain control drugs but also stimulants, such as MDMA (“ecstasy”), and psychedelics, such as 
LSD (lysergic acid diethylamide).