Before the provision was passed last year, the DEA's role with prescription drugs was primarily to decide how much of a controlled drug each company got to make, and then to monitor the use of those drugs on the market. Now, however, the DEA must sign off on any new FDA-approved medications containing controlled substances before they can be sold.
The FDA's deputy commissioner for medical and scientific affairs, Scott Gottlieb, said yesterday that the agency opposed the legislation, which for the second year in a row was added by the House to the yearly appropriations bill for several major departments. 'Specific language attached to the appropriations bill would ultimately delay access by physicians and their patients to important, safe and effective pain management and palliative care medicines,' Gottlieb said. He said giving DEA authority over traditional FDA territory could upset 'a delicate balance for managing both safety and access.' Although the dispute is ostensibly over a limited change in how controlled drugs are approved and labeled, it has become something of a stand-in for a larger battle over whether DEA's actions are intruding into the practice of medicine and denying pain sufferers relief they need.
Link to Washington Post article.