US groups renew call for expedited antibiotics pathway
This article was originally published in SRA
A coalition of drug makers in the US joined the Infectious Diseases Society of America (IDSA) and several other groups in again urging US lawmakers to create an expedited pathway for the Food and Drug Administration to approve antibiotics intended to treat serious or life-threatening infections for which there are currently few or no satisfactory treatment options1,2.
The limited population antibacterial drugs (LPAD) pathway would encourage the development of antibiotics to treat highly resistant infections by allowing the FDA to approve the medicines based on trials using smaller subpopulations with the most serious illnesses, the coalition – known as the Antibiotics Working Group (AWG) – and IDSA said in a 31 July letters to Senate lawmakers.
Regulators have acknowledged that a limited-use designation like LPAD could be used to help reduce the development of resistance to antibacterials by restricting the medicines to the most appropriate and necessary patients3.
The FDA held a public hearing in February to gain input on whether an LPAD or another pathway for serious or life-threatening conditions with unmet medical needs was necessary in light of the agency's other expedited pathways, including the new breakthrough therapy designation – with regulators receiving mixed feedback at the meeting4.
US drug industry association PhRMA was among those raising concerns that adding yet another regulatory pathway to the FDA's plate could result in confusion of expectations or a diversion of resources from existing mechanisms5.
The AWG, IDSA and the other groups asserted that the LPAD's streamlined process would provide patients with more rapid access to potentially life-saving therapies by lowering regulatory barriers to the development of antibiotics they most need, providing an incentive for companies that otherwise would be discouraged by prohibitively high development costs and lengthy testing timelines.
Narrow indications for LPAD drugs could create conditions for value-based or premium pricing for high-need antibiotics, which the groups said would encourage greater research and development investment, the groups said.
The LPAD designation and labeling also would help encourage judicious use of products approved under the pathway, which the groups said would be "an important goal if we are to preserve the effectiveness and promote stewardship of these vital medicines over time."
The AWG comprises Cempra, Durata Therapeutics, Rib-X Pharmaceuticals, Theravance, The Medicines Company, Optimer Pharmaceuticals and Trius.
References
1. ISDA and The Pew Charitable Trust letter to US Senate, 31 July 2013, www.idsociety.org/uploadedFiles/IDSA/Policy_and_Advocacy/Current_Topics_and_Issues/Antimicrobial_Resistance/10x20/Letters/To_Congress/Limited%20Population%20Antibacterial%20Drug%20(LPAD)%20Pathway%20Core%20Principles%20(PDF).pdf
2. US FDA seeks to foster new antibacterial drug development with streamlined approach, Scrip Regulatory Affairs, 9 July 2013
3. Adaptive licensing US style: FDA proposes another expedited pathway for new drugs, this time for 'limited' use, Scrip Regulatory Affairs, 16 January 2013
4. Does US need another expedited development pathway? Groups weigh in, Scrip Regulatory Affairs, 6 February 2013
5. US FDA's limited-use drug approval pathway proposal: A fickle flavor of the month?, Scrip Regulatory Affairs, 4 March 2013