Posted on June 26, 2015
The 21st Century Cures Act, unanimously approved in May 2015 by the House Energy and Commerce Committee, increases funding for drug development and calls for the creation of a special pathway for approval of antibacterial and antifungal drugs.1
“In the last century, American medicine leapt from medicine shows to the mapping of the human genome,” said Rep. Diana DeGette, a co-sponsor of the bill and Energy and Commerce Committee Member. “With the 21st Century Cures Act, we seek to support the biomedical community in making a similar leap forward in this next century. With billions in support for our premier research and development institutions and comprehensive reform of our systems, 21st Century Cures will make a real difference in the lives of patients and their families.” 2
For professionals involved in the antimicrobial stewardship, the bill’s Antibiotics Drug Development section provides potential good news. If enacted, the bill would create a “limited population pathway” for approval of certain antimicrobial drugs that treat serious or life-threatening diseases, conditions or indications” that current therapies do not adequately address. To qualify for the accelerated pathway, the pharmaceutical manufacturer would need to identify the specific population that would benefit from the drug. Drugs approved under the new pathway would bear a label saying: “This drug is indicated for use in a limited and specific population of patients.”
In House committee hearings, representatives who have advocated for the expedited pathway for limited population antibacterial drugs have noted that these drugs need to be approved based on smaller, more rapid clinical trials as they affect a relatively small number of patients.3
According to Amanda Jezek, director of Government Relations for the Infectious Diseases Society of America (IDSA), the organization is “very pleased that the bill prioritizes the research and development of some of the most urgently needed new antibiotics to treat serious or life threatening infections with few or no current treatment options.”4 In an interview with Medical Research, Jezek also noted that “the provisions aimed at antibiotic research and development also include language aimed at making sure the antibiotics are used appropriately and that their use is monitored, both of which are critical for addressing antibiotic resistance.”
Devices that test for antimicrobial susceptibility would be eligible for the accelerated pathway as well. The bill increases Medicare reimbursement for new antimicrobials that treat serious or life-threatening infections and for which current therapies are inadequate.
To advance proper good antimicrobial stewardship, the proposed legislation calls for the FDAFood and Drug Administration to establish a website that recommends the use of specific drugs for various bacteria and fungi. With the development of multidrug resistant organisms and evolving susceptibility, such a website would keep hospitals across the nation current on the most effective treatments for increasingly resistant pathogens.
What do you think about the creation of a special pathway for approval of selected new antimicrobials?
H.R. 6. The 21st Century Cures Act.
The 21st Century Cures Act: Unanimously Approved. Energy & Commerce Subcommittee. May 21, 2015.
Antibiotics Incentives and NIH Funding Boost in 21st Century Cures Draft Bill. IDSAnews. May 2015.
The Infectious Diseases Society of America Comments on the 21st Century Cures Bill Including Antibiotic Development. Medical Research. June 7, 2015