Rx-to-OTC switch­es: What FDA's new pro­posed rule means for phar­ma com­pa­nies

As the FDA kicks off its re­view of a re­quest to make the birth con­trol pill an over-the-counter drug, the agency al­so re­cent­ly un­veiled a wide-rang­ing pro­pos­al that would speed up these pre­scrip­tion to OTC switch­es by of­fer­ing an in-be­tween path­way for drugs that can be mar­ket­ed as both pre­scrip­tion and OTC drugs.

Cur­rent la­bel­ing lim­i­ta­tions have led to chal­lenges for spon­sors at­tempt­ing these Rx-to-OTC switch­es, FDA says, but the pro­posed rule from late last month would al­low for the si­mul­ta­ne­ous mar­ket­ing of the pre­scrip­tion and OTC ver­sions of the same drug un­der what will be known as non­pre­scrip­tion drugs with an Ad­di­tion­al Con­di­tion for Non­pre­scrip­tion Use (AC­NU).

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.