As we previously reported, on February 12, 2015, Senators Hatch and Whitehouse introduced the Ensuring Patient Access and Effective Drug Enforcement Act of 2015. Also on that date, the Senators introduced legislation that would also amend the Controlled Substances Act, as well as the Food, Drug, and Cosmetic Act. This legislation addresses, among other things, the scheduling of new molecule entities (“NME”) that have been approved by the Food and Drug Administration (“FDA”). If passed, the legislation will require the Drug Enforcement Administration (“DEA”) to issue an Interim Final Rule placing the NME in the appropriate drug schedule within 90 days of receipt of the scientific and medical evaluation and recommendations from the Secretary of Health and Human Services or within 90 days of receipt of notification from the FDA of approval and scheduling recommendation of the NME.
This is companion legislation to the Improving Regulatory Transparency for New Medical Therapies Act, which was recently introduced in the House and approved by the Subcommittee on Health, Energy and Commerce Committee.
The average time for DEA to schedule NMEs has significantly increased over the past several years – from 49 days in the late 1990s to 238 days in recent years. In 2013, Eisai Inc. sued DEA to timely schedule Fycompa, a drug therapy approved to treat epilepsy. Ultimately, Eisai had to wait more that a year for DEA’s scheduling action which negatively impacted patient access to an FDA-approved drug and significantly reduced the company’s marketing exclusivity period.