Obama Signs Law Extending Exclusivity of Controlled Drugs and Biologics

In a win for drugmakers, President Barack Obama signed into law a bill that extends exclusivity periods for new drugs and biologics containing a controlled substance by changing the date they are considered to have been approved from the current FDA sign-off to when the Drug Enforcement Agency schedules them for sale.

The Improving Regulatory Transparency for New Medical Therapies Act, H.R. 639, passed following complaints from drugmakers that they have lost exclusivity rights while waiting for DEA action (DID, Oct. 28).

The law also allows a controlled drug or biologic to be sold before the DEA assigns it to a controlled substance schedule. It effectively resets the date of approval by requiring the agency to issue an interim final rule to place a product in a Controlled Substances Act schedule within 90 days of when the drug was approved by the FDA or when HHS sends a scheduling recommendation to the DEA, whichever comes later. A product can be marketed with the interim schedule as it awaits a final decision. — Michael Cipriano

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