Bills, Bills, Bills: Congress Advances Bills to Address Drug Competition

Bills, Bills, Bills: Congress Advances Bills to Address Drug Competition

Source: 
FDA Law Blog
snippet: 

There’s no question that drug pricing is one of the most important issues in health care right now, and while such pricing considerations are outside FDA’s statutory mandate, it has not stopped FDA from trying to address pricing issues through enhancing drug competition (see, for example, our discussions of the Drug Competition Action Plan and the Biosimilar Competition Action Plan).  To that end, FDA has attempted to limit exclusivity awards in an effort to facilitate generic access, by, for example, requiring proof of clinical superiority for Orphan Drug Exclusivity (Depomed) or by limiting the definition of active ingredient to active moiety (Vascepa).  But courts have not necessarily agreed with FDA’s interpretation of its governing statute (the FDCA).  In some of these instances—Depomed serving as a prime example—Congress has not hesitated to step in.