September 22, 2014
The U.S. government was all about antibiotic resistance last week.
New antibiotic development was the subject of discussion at a House Committee on Energy and Commerce health subcommittee hearing on Friday. Discussions at the hearing, held to consider the Antibiotic Development to Advance Patient Treatment (ADAPT) Act, highlighted the severity of the public health crisis and weighed the possibilities of facilitated FDA approval for novel antibiotics.
Representatives Gene Green (D-TX) and Phil Gingrey (R-GA), cosponsors of the bipartisan-supported bill, opened the hearing by speaking on the necessity for action.
Gingrey spoke about how his brother’s life was saved by antibiotics shortly after penicillin was discovered in 1941, and how new drug discovery had been fruitful and successful in past decades.
“We know we can do this, and we know we should do this – it’s been done before,” he said.
The ADAPT act would facilitate new drug development by allowing for FDA approval based on limited data, as studies for antibiotics require individuals who have recently acquired a bacterial infection – a population that is difficult to obtain in the numbers normally necessary for approval.
Several of the witnesses recognized that accelerated approval is critical because of the urgent need for new antibiotics, but the consensus amongst both representatives and expert witnesses was that the current system for development itself is broken.
Dr. Kevin Outterson, a professor at the Boston University Law School (who wrote a post on the CDDEP blog last week), said in his statement that the economic incentives just aren’t present in the current market for new and effective antibiotics. Not only are antibiotics not as lucrative as other drugs, but they also pose a problem of misaligned interests: companies need to maximize sales to earn a profit, but an increase in antibiotic use means greater resistance and reduced efficacy.
Other witnesses were concerned about maintaining scientific rigor and patient safety throughout the development process. Dr. Janet Woodcock, chair of the FDA’s pharmaceutical division, emphasized that though accelerated approval would help get critical new antibiotics on the market, there were inevitable tradeoffs in other areas.
The hearing’s witnesses ultimately stressed that even if passed, the ADAPT act would just be a part of a decades-long strategy that will require extensive funding and commitment.
“In the movies, heroic research scientists discover the cure before the credits roll; in real life, research programs require at least a decade and generally longer to deliver an effective antibiotic,” said Outterson.
Photo courtesy of Creative Commons
