On November 16, 2015, the House of Representatives approved HR 639, the Improving Regulatory Transparency for New Medical Therapies Act, clearing it for the President. The legislation would amend the Controlled Substances Act (CSA) to make procedural changes intended to improve the efficiency, transparency, and consistency of the Drug Enforcement Agency's (DEA) process for scheduling new drugs. According to the bill sponsor, the current lack of predictability in the timing of DEA scheduling decisions results in uncertainty in the drug development process and delays patient access to new therapies. HR 639 would require the DEA to issue an interim final rule to place a drug that has both not been marketed previously in the United States and has abuse potential in a CSA schedule within 90 days of when the drug was approved by the Food and Drug Administration (FDA) when the FDA sends a scheduling recommendation to the DEA, whichever comes later. The interim final rule would constitute a "final scheduling decision" that allows a manufacturer to begin marketing the product. For purposes of calculating a new drug's exclusivity and patent term restoration periods under the Hatch-Waxman Act, HR 639 would clarify that for a new drug that has been recommended to be scheduled by the FDA, the effective date of approval would be the later of FDA approval of the drug product or the issuance of an interim final rule by DEA scheduling the new drug. The legislation also would impose deadlines for scheduling drugs that will only be used in clinical trials.
This article is presented for informational purposes only and is not intended to constitute legal advice.