21st Century Cures Explores Paths to Address Antibiotic Resistance and Encourage New Drug Development

Press Release

The Subcommittee on Health, chaired by Rep. Joe Pitts (R-PA), today held a hearing to review the growing threat of antibiotic resistance and discuss ways to foster new drug development. Members heard from the Director of the Food and Drug Administration's Center for Drug Evaluation and Research Dr. Janet Woodcock and important health leaders and stakeholders to gain input on the global health crisis as part of the committee's ongoing 21st Century Cures initiative. Witnesses suggested improving incentives for new drug development, streamlining clinical trials for highly resistant drug development, and considering changes to exclusivity periods for new drug development.

Pitts explained, "British Prime Minister David Cameron warned in July that if we do not confront the threat of antibiotic resistance, we could be "cast back into the dark ages of medicine where treatable infections and injuries will kill once again.' And, just yesterday, the president announced an Executive Order focused on efforts his administration plans to take with regards to the antibiotic resistance issue."

Energy and Commerce Committee Chairman Fred Upton (R-MI) added, "This public health crisis is an important topic for us to explore as we continue our work on the bipartisan 21st Century Cures initiative and work to bring more effective treatments to patients more quickly."

"It is virtually undisputed that we are facing a tremendous public health crisis because of the rise of serious antibacterial infections and the simultaneous decline in R&D in this area," said Dr. Woodcock. "FDA is using the tools we have to begin to strengthen the antibiotic drug pipeline. However, more work is needed to improve the current climate, and FDA is looking forward to continuing to work with stakeholders to address this public health crisis."

Dr. Barbara Murray, President the of Infections Diseases Society of America, offered support for the committee's efforts as well as the ADAPT Act, bipartisan legislation authored by committee members Rep. Phil Gingrey (R-GA) and Rep. Gene Green (D-TX). She explained, "Antibiotic R&D, as you have heard, faces significant barriers. Discovery is hard. Scientific challenges lead to very high development costs. Economically, antibiotics have a very poor return on investment, because they are typically priced low, used for a short duration, and held in reserve by us to try to control antibiotic resistance."

Gingrey added, "As we continue with the 21st Century Cures initiative we must work in a bipartisan manner to address this growing problem across the country. … Make no mistake, the cost of inaction in the fight against life threatening infections is grave and the CDC has already provided us with the statistics to prove that."

"In the design of policies to meet this need of growing magnitude, focus must be fixed on the end goal, namely: more therapeutic and preventive options for patients, sooner," said Dr. Adrian Thomas of Janssen Global Services. "To achieve this, we must foster more "shots on goal,' galvanizing and mobilizing the larger innovator community to apply its time, talents and resources to the challenge of antibiotic resistance."

"Currently in the news and foremost on our minds is Ebola. Ebola is a viral disease, but the next pandemic could be bacterial and arise in our own hospitals and communities," commented Boston University Law Professor Kevin Outterson. "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."

Dr. Kenneth Hillan with Achaogen, Inc. added, "The process from initiation of an antibiotic discovery program through clinical trials and licensure can take well over 10 years. Given this long timeline, it is important to provide incentives to launch antibacterial research programs on an ongoing and predictable basis."

The Pew Charitable Trusts Director Allan Coukell commented, "The Energy & Commerce committee has long understood the threat of antibiotic resistance and has done great work to bring this issue to the national stage. The need for new antibiotics and the potential an LPAD pathway has to bring therapies to critically-ill patients has been highlighted at a number of hearings and roundtables the committee has held as part of the 21st Century Cures initiative. We appreciate your leadership and continued commitment to this issue."

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