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Initiative launched in Congress to bolster new antibiotic development
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US Reps. Fred Upton, R-Mich., chairman of the Energy and Commerce Committee, and Diana DeGette, D-Colo., a chief deputy whip, today launched the 21st Century Cures Initiative during a hearing, titled “21st Century Cures: The President’s Council of Advisors on Science and Technology Report on Drug Innovation.”
The hearing was held by Reps. Joe Pitts, R-Pa., chairman of the health subcommittee, and Frank Pallone, D-N.J.
Since the 2010 launch of the 10 X ’20 Initiative by the Infectious Diseases Society of America, the association has called for incentives to revitalize the weak antibiotic pipeline.
“My colleagues and I continue to see increasing numbers of patients with serious and life-threatening infections that are resistant to our current arsenal of antibiotics. We desperately need new drugs to save our patients’ lives. Congress made an important down payment on antibiotic research and development with the Generating Antibiotic Incentives Now (GAIN) Act in 2012,” IDSA President Barbara E. Murray, MD, FIDSA, said in an IDSA statement after the hearing. “But the crisis of antibiotic resistance and lack of new antibiotics continue to threaten and kill patients.”
Barbara E. Murray
According to a Committee on Energy and Commerce memorandum, President’s Council of Advisors on Science and Technology (PCAST) identified opportunities and put forth constructive proposals to achieve an ambitious goal for the United States: “Double the current annual output of innovative new medicines for patients with important unmet medical needs, while increasing drug efficacy and safety, through industry, academia, and government working together to double the efficiency of drug development, by decreasing clinical failure, clinical trial costs, time to market, and regulatory uncertainty.”
In addition, PCAST specifically recommends creation of a new pathway for initial approval of drugs shown to be safe and effective in a specific subgroup of patients.
The GAIN Act provided an economic incentive for antibiotic research and development, but significant challenges, including regulatory hurdles, must still be addressed. For example, according to the IDSA, some of the most dangerous pathogens currently occur in relatively small numbers of patients, making it difficult to populate traditional, large-scale clinical trials.
The IDSA also said the bipartisan Antibiotic Development to Advance Patient Treatment (ADAPT) Act (HR 3742), introduced in December by Reps. Phil Gingrey, MD, R-Ga., and Gene Green, D-Texas, would help address this problem by allowing companies to study new antibacterial drugs to treat serious or life-threatening infections for which there is an unmet medical need in smaller clinical trials and to receive approval for use of the drug in a limited population. This approach was recommended by PCAST in its 2012 report to the president on Propelling Innovation in Drug Discovery, Development and Evaluation, according to an IDSA press release.
“IDSA is extremely concerned that without the ADAPT Act, the lifesaving antibiotics our patients so desperately need will not be developed,” Murray said.