Obama Signs Bill Extending Exclusivity of Drugs With Controlled Substances

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, Public Law 114-89, passed following complaints from drugmakers that they have lost exclusivity rights while waiting for DEA action.

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.