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Bipartisan agreement crucial to antibiotic research, development
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The United States House and Senate members have announced a bipartisan agreement on the FDA’s Safety and Innovation Act, which includes language to address antibiotic research and development and to bring new antibiotics to the country, according to an Infectious Disease Society of America statement.
IDSA has advocated for such antibiotic incentives, and hopes that the incentives spark interest in this area of medicine. Their 10 x ’20 initiative outlines the need to bring antibiotics to people who need them in the United States and abroad. They say that other incentives will be necessary to reach these goals.
Possible incentives include tax credits for research and development, public-private collaborations and the Limited Population Antibacterial Drug mechanism to streamline FDA approval, which the IDSA recently proposed.
“New, improved diagnostics are critically important for antibiotic development as well as for ensuring that antibiotics are used appropriately post-approval,” IDSA president Thomas G. Slama, MD, FIDSA, said in the statement. “IDSA will continue to work with other endorsers of the 10 x ’20 initiative to lead the charge for additional action.”
Perspective
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Elizabeth S. Dodds Ashley, PharmD, MHS, BCPS
I think that it is exciting that we have attention on mechanisms to combat antimicrobial resistance. It is certainly needed, is an important area and one tool in that is going to be development of new drugs - an area that has not received adequate attention in recent years in my opinion. However, this needs to be combined with approaches and other mechanisms to control antibiotic resistance and improve outcomes in patients. I think that antimicrobial stewardship has a very important place at that table and should also be the focus of these efforts. My only concern with the GAIN Act is, not that we don’t support this act as infectious disease pharmacists, but it’s that we also don’t want people to rely on this as the only mechanism to combat antimicrobial resistance. There needs to be realistic approaches to this.
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George Pankey, MD
I am pleased the Congress has officially recognized the global problem of antimicrobial resistance of bacteria and is trying to do something about it. However, incentives to develop new antibiotics doesn't seem to the best use of our limited resources. Implementation of real time microbiologic diagnostics, antimicrobial stewardship, and infection control are likely to yield more positive results. In addition, vaccines such as Hemophilus influenza b and pneumococcal are important in the control of penicillin resistant strains. The development of new vaccines for other resistant bacteria should be encouraged. There is a disconnect between agricultural, dental, medical, and veterinary use of antimicrobials as well as a disconnect of usage between countries. These disconnects are problematic for antimicrobial resistance. New antibiotics won’t solve those problems.
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Richard F. Jacobs, MD
With all the stalemates in our US Congress and the inability for constructive agreement on even the simplest of issues, it is encouraging that a common theme over such an important issue was achieved. IDSA is to be applauded for a tenacious dedication to the public health problem. Safe and effective anti-infective agents in a time of drug resistance and stagnation of our pipeline are critically important to physicians who continue to take care of sick patients. This is a good first step.Click Here to Manage Email Alerts