From DCAT Value Chain Insights (VCI)
President Barack Obama has signed into law, the "Improving Regulatory Transparency for New Medical Therapies Act," which amends the Controlled Substances Act to require the US Department of Justice (DOJ) to issue a final interim rule for a drug product recommended for controls by the US Food and Drug Administration no later than 90 days after the DOJ receives a recommendation for controls or the FDA approves the drug. The final interim rule is effective immediately.
In addition, the legislation clarifies that for this subset of drugs that must be scheduled, market exclusivity periods begin on the date a product can actually be marketed, just as it is for other new drug products. The bill will also allow a company applying to register with the US Drug Enforcement Administration (DEA) to manufacture a controlled substance to indicate on the application that the substance will only be used for clinical trials of a drug. DEA would be required to either make a final decision on the application for registration within 180 days or inform the applicant of the outstanding issues that must be resolved to reach a final decision.
For purposes of submitting an application to extend a patent, a drug product recommended for controls is considered to be approved and have permission for commercial marketing and use on the date of FDA approval or the date an interim final rule is issued, whichever is later.
The new law seeks to address concerns over delay by the Drug Enforcement Administration (DEA) in scheduling (i.e., classifying) a controlled substance following FDA approval.
Source: US Congress
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