FDA Prepares For LPAD: Orphan Drug Approvals Are Model
This article was originally published in RPM Report
Executive Summary
One of the bedrock consensus issues throughout the drafting of the “21st Century Cures” legislation has been that the bill should create a pathway for approval of new antibacterials for limited populations – known as LPAD. But what would it actually do?
You may also be interested in...
The First LPAD? Cempra May Try New Pathway For MRSA Antibiotic, Could Retrofit Solithromycin
Cempra Pharmaceuticals appears to be one of the first companies exploring the newly enacted “limited use” pathway for novel antibiotics. The company cited the approach as an option for fusidic acid for use against MRSA – but it sounds like it may also be on the table for the company’s recently rejected solithromycin.
The Popularity of “Special Pop”: Antibiotics Incentives and PDUFA V
The Infectious Diseases Society of America’s “Special Population” approval mechanism has proponents within FDA and industry. That makes it look like a good balancing proposal to complement the market incentives for anti-infectives being pushed under the GAIN Act add-on to PDUFA V. There is one big hurdle, however: GAIN’s major legislative proponent, Rep. Phil Gingrey (R-GA) does not like the limitations on use post-approval.
Drug Shortage Could Be Addressed By ‘Resilience Rating’ From Private Entity Under HHS Plan
US HHS is proposing a public-private partnership to assign ratings to manufacturers based on quality/resilience of supply, tied to a purchasing incentive program for providers. The non-agency approach may be key to overcoming industry and political objections.