Regulatory Focus™ > News Articles > New Law Redefines When Controlled Substances are Officially Approved

New Law Redefines When Controlled Substances are Officially Approved

Posted 30 November 2015 | By Zachary Brennan 

New Law Redefines When Controlled Substances are Officially Approved

Just before the Thanksgiving holiday weekend, President Barack Obama signed a new law that will effectively provide the pharmaceutical industry with more certainty on when controlled substances are officially approved.

The new law, known as the Improving Regulatory Transparency for New Medical Therapies Act, sets new deadlines for the US Drug Enforcement Administration (DEA) to schedule controlled substances, like opioids and other drugs that have the potential to be abused, following US Food and Drug Administration (FDA) approval, and it offers new clarity for when a drug is officially approved for the purposes of calculating its exclusivity and patent terms.

For a drug or substance that has never been marketed in the US, the new law requires DEA to schedule that drug within 90 days of FDA approval or when receiving a scheduling recommendation from FDA. In addition, the law clarifies that for a controlled substance, the market exclusivity period begins now on the day when DEA schedules the new drug, biologic or animal drug.

In addition, the new law requires DEA to notify controlled substance applicants within 10 days if an application is defective and include a statement for why the agency is not accepting the application.

Clinical researchers will also see some benefits from the law, as it would allow them to indicate on their DEA application that the controlled substance will only be used for clinical trials of a drug. DEA will also be required to review applications to manufacture a controlled substance (Schedule III, IV or V) for use in a clinical trial within 180 days of receiving the application, and Schedule I or II drugs within 180 days, not including a notice and comment period and a 90-day application window.

Causes for the New Law

Before this law passed, a controlled substance's exclusivity period began when FDA approved the product, though companies often waited long periods for DEA to schedule the substance, which effectively cut short their time on market without generic competition.

Last year, pharmaceutical manufacturer Eisai sued FDA when it refused to increase the exclusivity periods for two of its drugs that waited a year for DEA scheduling after approval. A judge later threw out the lawsuit, but this law was only in its infancy then. It remains to be seen how companies like Eisai might be able to use this law retroactively.

And as for the clinical research provisions, a House report on the law notes: “Inconsistency and lengthy review times at DEA are not limited to scheduling decisions for new drugs, but also apply to the review of registration applications submitted by companies in advance of conducting clinical trials. The DEA registration does not distinguish between the manufacturing of a controlled substance for marketing and the manufacturing of a controlled substance for the use in clinical trials.”

In addition, the law, which passed the House in March and the Senate in October, helps to provide industry with a timetable for DEA to grant approval of registration applications and a more transparent process for the applicant to determine the reasons for a delay in DEA’s processing of the application.

HR 639 – Improving Regulatory Transparency for New Medical Therapies Act

House Report



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