Congress Should Oppose Bill That Undermines Patient Safety and Fails to Tackle the Rise of Antibiotic Resistance

Note: The U.S. House Committee on Energy and Commerce holds a subcommittee hearing today titled "21st Century Cures: Examining Ways to Combat Antibiotic Resistance and Foster New Drug Development." The subcommittee is examining the serious public health issues involving the rise of antibiotic resistant pathogens. On Thursday, the President's Council of Advisors on Science and Technology (PCAST) released a report to the President, Combating Antibiotic Resistance. Below are comments from Public Citizen experts.

"Antibiotic resistance is an urgent public health problem affecting millions of people across the country and around the world. However, the Antibiotic Development to Advance Patient Treatment (ADAPT) Act of 2013 is the wrong proposal to address this issue. ADAPT does not address the core economic challenges and bottlenecks regarding the development and discovery of new antibiotics. Instead, the legislation places patient safety at risk by compromising the U.S. Food and Drug Administration's (FDA) approval process."

"Still worse, ADAPT places key parts of the approval process in the hands of private stakeholders who may be unduly influenced by the industry."

"To effectively combat antibiotic resistance in the 21st century, we need incentives that spur the development of truly novel antibiotics that help patients. We should not and cannot undermine necessary approval protections that are in place to tackle antibiotic resistance."

- Lisa Gilbert, director, Public Citizen's Congress Watch division

"ADAPT fails to address the source of antibiotic resistance. Antibiotic use is the most important factor that leads to resistant pathogens. ADAPT has no safeguards to conserve novel antibiotics for use in limited populations. Instead it attacks the standards set by the FDA."

"Despite good intentions, ADAPT does not tackle the grave public health concern caused by antibiotic resistance. A better and more comprehensive approach to confront this problem would be to support the National Institutes of Health in addressing the real scientific challenges underlying innovation. It would strengthen, not undermine, the FDA approval process as well as remove any conflicts of interests. Finally, a better approach would be to emphasize the role of antibiotic stewardship."

"Congress must oppose this legislation and instead embrace a stronger proposal that aligns the proper incentives for medication discovery while maintaining the public's trust that approved antibiotics are both safe and effective for treatment."

- Vijay Das, health care advocate, Public Citizen's Congress Watch division

View Public Citizen's submitted comments for the hearing.