A bipartisan bill working its way through Congress could have a major effect on how the Drug Enforcement Agency (DEA) classifies drugs under the Controlled Substances Act (CSA). The Improving Regulatory Transparency for New Medical Therapies Act (H.R. 639) was recently approved by the full House of Representatives and moved to the Senate, which has previously introduced related legislation. If adopted into law, the legislation would bring a measure of speed and predictability to the process of making new drugs available.
The CSA provides for drugs to be scheduled into various classes of control, with greater restrictions on those that have the higher likelihood of being abused. For example, there are restrictions on refills and the quantity of drugs that can be prescribed at a single time for drugs classified as Schedule II, which includes painkillers like OxyContin and Percocet.
Under the current regulatory regime, after a new drug receives approval from the Food and Drug Administration (FDA), it still cannot be marketed until the DEA gives its sign-off under the CSA. Certain patient advocacy groups argue that the DEA takes an unnecessarily long time to schedule new treatments, delaying new products from becoming available to patients in need. For example, according to a review conducted by the Epilepsy Foundation, between 1997-1999 and 2009-2013, the time that elapsed between FDA approval of a drug and the DEA’s scheduling increased from an average of 49 days to an average of 238 days. The Regulatory Transparency Act is meant to shorten this period by placing time-related requirements on the DEA’s process for scheduling drugs.
Under the Regulatory Transparency Act, time limits would be imposed on the DEA in its classification of drugs. Introduced in the House of Representatives by Rep. Joe Pitts (R-Penn.) and Rep. Frank Pallone (D-N.J.), the bill would apply to all but the most heavily regulated controlled substances – it would not apply to Schedule I drugs, which include the likes of heroin, LSD, and marijuana. Specifically, the Regulatory Transparency Act provides that if the FDA recommends the new drug be scheduled as a II, III, IV, or V substance, the DEA must issue an interim final rule scheduling the drug no later than 90 days following receipt of the FDA’s recommendation. The rule would become immediately effective as an interim final rule.
The Regulatory Transparency Act would also place time limits on the DEA issuing approval for the use of a drug in a clinical trial. Specifically, the bill would require the DEA to review applications to manufacture a controlled substance (Schedule III, IV, or V substances) for use in a clinical trial within 180 days of receiving the application. For Schedule I and II drugs, the DEA must review applications within 180 days, plus an additional 90-day notice and comment period.