PhRMA skeptical of limited-use pathway

The Pharmaceutical Research and Manufacturers of America is highly skeptical about proposals to create a new expedited development pathway for limited-use drugs, according to comments the trade association plans to submit to FDA this week. The comments are a response to a Feb. 4 meeting and FDA's call for public comments on creating an alternative pathway for drugs to address unmet medical needs (see BioCentury, Feb. 25).

In its comments, PhRMA states that it is "unclear whether an additional pathway is needed when existing pathways are not fully utilized or underutilized" and when FDA is just starting to implement a new breakthrough drug pathway and other provisions in the FDA Safety and Innovation Act "that will surely help expedite development and approval of new medicines." Much of the discussion of the limited-use pathway has focused on antibiotics, but PhRMA notes in its comments that FDA can use "existing regulatory flexibility proactively to facilitate development and rapid approval of new antibiotics." ...