Proposed Federal Legislation Aims to Speed Up DEA’s Scheduling of New Medicines and Approval of DEA Registrations in Certain CircumstancesApril 7, 2014
By John A. Gilbert, Jr. –
A new bill introduced in Congress, H.R. 4299 (titled “Improving Regulatory Transparency for New Medical Therapies Act”), would significantly streamline the drug scheduling process for new medical therapies and reduce the potential for unnecessary delays in the availability of these needed medicines. The bill would also require the Drug Enforcement Administration (“DEA” or “Agency”) to make a decision on new registration applications for the manufacturing and distribution of drugs and substances used in clinical trials. A hearing on the bill is scheduled before the House Energy and Commerce Committee on April 7, 2014.
As reported here and here, the recent example of the long delay in DEA’s scheduling of Eisai’s FYCOMPA (perampanel) – more than a year after it was approved for marketing by the FDA – highlights the need for a change in the process. The bill would amend the Controlled Substances Act (“CSA”) to require DEA to issue an interim final scheduling rule within 45 days of receiving a recommendation from the Department of Health and Human Services (“HHS”) to schedule a new drug or substance not previously marketed or scheduled in the United States. The bill would require DEA to take such action pursuant to the “good cause” exception to issuing a notice of proposed rulemaking under the Administrative Procedures Act (5 U.S.C. § 553(b)(3)(B)). The interim final rule would be made immediately effective pursuant to 5 U.S.C. § 553(d)(3).
As we discussed previously, scheduling based on the HHS recommendation is reasonable and rational for a new medicine where the drug has not been marketed in the United States and thus there is no actual abuse data available. Under such circumstances, the HHS and FDA scientific and medical review of the drug is the best source of abuse potential, so scheduling a new drug on this basis is consistent with the public interest. It also avoids the issue previously reported where Eiasi faced losing a significant period of its patent exclusivity solely because it had to await DEA’s scheduling notice for the newly approved drug.
The bill would also amend the CSA to put a time limit on DEA’s review of an application for a DEA registration to be used only for the manufacture or distribution of a controlled substance for clinical trials. The DEA would be required to make a decision within 180 days of receiving the application. If the Agency does not make a decision on the application within this time, the Agency would have to give written notice to the applicant as to any outstanding issues that must be resolved in order to make a final decision on the application and the estimated date on which a decision would be made.
Neither the CSA nor DEA regulations currently impose any time limits on DEA to decide on whether to grant or deny new applications for any DEA registration. Imposing such time limits could be beneficial to all applicants – not just manufacturers or distributors for use in clinical trials. We would like to see such limits imposed on all DEA applications for registration; not just in the narrow context expressed in the bill. There are some obstacles where the 180-day time limit may be difficult, e.g., where DEA is required to publish a notice in the Federal Register for applications for bulk manufacturing of narcotic drugs; however, in most cases requiring DEA to act on an application within, for example, six months would not likely be an unreasonable burden on the Agency.