Obama Signs Bill Extending Exclusivity of Drugs With Controlled Substances

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December 07, 2015.

President Obama has 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 move is reported by FDA News as "a win for drugmakers".

The law also allows a controlled drug or biologic to be sold before the DEA assigns it to a controlled substance schedule. According to FDA News, "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."