As part of an overall strategy for addressing the public health crisis of antibiotic resistance, the Infectious Diseases Society of America (IDSA) have submitted a proposal to the House Energy and Commerce Committee Subcommittee on Health, during a March 8 hearing on the U.S. Food and Drug Administration (FDA) Prescription Drug User Fee Act (PDUFA) reauthorization legislation.
IDSA proposed a new drug approval approach in order to encourage pharmaceutical companies to develop urgently needed, life-saving antibiotics to treat people with serious infections where few or no treatment options are available.
The proposal is called the “Special Population Limited Medical Use (SPLMU)” mechanism.
This year in Congress, PDUFA is considered one of the few must-pass bills. During the hearing, legislators will decide whether to incorporate within PDUFA pending legislation known as the Generating Antibiotic Incentives Now (GAIN Act). The Act proposes incentives to address the lack of research and development (R&D) of antibiotics.
Brad Spellberg, M.D., co-chair of IDSA’s Antimicrobial Availability Task Force, explained:
“Antimicrobial resistance is unequivocally one of the world’s greatest public health threats, and we’ve been sounding the alarm about it – and the lack of new antibiotics in development – for years. This new mechanism provides the opportunity to address this public health crisis while there is still time to fix it.”
As a result of scientific, regulatory and economic obstacles, antibiotic research and development in the United States is more difficult. At present, there are only 2 or 3 pharmaceutical companies with large antibiotic R&D programs, compared with nearly 20 in 1990.
The SPLMU mechanisms enables pharmaceutical companies to examine SPLMU medications faster, in significantly fewer patients that is required at present, and at considerably less expense – as the drugs are intended for specific populations where no other treatment options are available.
SPLMU designation reserves a medication that is only entitled to be used in particular individuals in whom the benefits outweigh the risks. The drug is to be taken prudently to decrease the rate of resistance.
Robert Guidos, vice president of public policy and government relations at IDSA, explained:
“The proposed SPLMU drug approval mechanism will bring critically needed innovation to the anti-infective pipeline, encouraging antibiotic development and lowering the hurdles that need to be cleared to get these critically needed drugs to patients who desperately need them.
In addition, we’ve designed it to foster antimicrobial stewardship, so these drugs will be used only when appropriate, extending their lifesaving power.”
If immediate action is not taken to develop new drugs and address antibiotic resistance, individuals will die from common infections as they did before these medications were developed, and where several medical interventions, such as organ transplantation, surgery, chemotherapy, and care for premature infants – become impossible.
In 2011, 11-year-old Addie Rerecich, of Tucson, Ariz., went to her doctor reporting pain in her hip. Rerecich discovered she had life-threatening strains of Escherichia coli (E. coli), Staphylococcus aureus, as well as other resistant infections. These infections caused pneumonia, sepsis, pulmonary embolism, as well as a life-saving lung transplant. During the 5 months Rerecich was hospitalized, she received an antibiotic called colistin, a highly-toxic last-resort medication that can cause organs to fail, as it was the only drug available that was effective against her infections.
Click here to read more about Addie’s story, and several others.
Furthermore, the IDSA testimony advises other public policy strategies – within the context of the GAIN Act and PDUFA – such as different push and pull economic incentives and support for new diagnostics development and antimicrobial stewardship programs in order to reduce the economic restraints that have played a role in the market failure in antibiotic research and development.
In February 2012, a letter was sent to House and Senate leaders by a group of 50 organizations representing patients, health systems, veterans, health care providers, children’s health, seniors, women’s health, and other key stakeholders, requesting that they address the serious and increasing issues of antibiotic resistance as well as antibiotic R&D as part of PDUFA.
Written by Grace Rattue