Pew Applauds 21st Century Cures Act’s Antibiotic Resistance, Substance Abuse, Medical Device Provisions
WASHINGTON—The U.S. House of Representatives today passed the 21st Century Cures Act, a wide-ranging bipartisan health bill. Allan Coukell, senior director for health programs at The Pew Charitable Trusts, issued the following statement:
“We applaud the U.S. House of Representatives for taking concrete steps to address the critical public health issues of antibiotic resistance and prescription drug abuse, while also supporting a medical device safety provision. The 21st Century Cures Act directs the Food and Drug Administration to establish a targeted approval pathway for new, much-needed antibiotics. It also authorizes the use of patient review and restriction programs (PRRs) in Medicare to help curb inappropriate uses of opioids and other controlled substances that have resulted in a nationwide prescription drug abuse epidemic. Last, the legislation would express Congress’ support for giving patients and doctors better information on the medical devices used in care.
“Antibiotic-resistant bacteria continue to emerge and spread at an alarming rate and are becoming increasingly difficult—even impossible—to treat with existing medications. Millions of patients acquire serious and life-threatening infections in the U.S. each year, and tens of thousands die as a result. At the same time, the development of new antibiotics has dwindled, leaving too many patients with few or no treatment options.
“The Limited Population Antibacterial Drug, or LPAD, pathway called for in the 21st Century Cures Act would help to make it more feasible—scientifically and economically—to develop new antibiotics that address the unmet medical needs of specific patient populations. It is not currently feasible to identify and enroll patients with highly resistant bacterial infections in sufficient numbers for large clinical trials because of the sporadic and concentrated nature of outbreaks and the relatively small numbers of patients with these serious conditions. By allowing approval of targeted antibiotics based on smaller clinical trials, the LPAD pathway will help to address regulatory barriers to developing desperately needed treatments while still requiring new antibiotics to meet existing FDA standards of evidence for safety and effectiveness.
“The legislation also addresses prescription drug abuse. Opioid-related prescription drug overdoses kill more than 16,000 people each year in the United States—an increase of more than 300 percent since 1998. At the same time, the rate at which health care professionals prescribed these drugs quadrupled from 1999 to 2010.
“The 21st Century Cures Act allows Medicare plan sponsors to use PRR programs, which require individuals at risk for prescription drug abuse to obtain controlled substances only from predesignated pharmacies and prescribers. These programs—which have helped state Medicaid plans decrease prescription drug abuse and improve continuity of care—are essential for reducing abuse of pain medications and other controlled substances while preserving access for patients with legitimate medical needs.
“Although no single policy will address all the complex challenges of these pressing public health issues, we are encouraged to see LPAD and PRR legislation advancing in Congress and hope the bipartisan and bicameral support will continue to grow.
“Separately, leaders in the Senate have put forward similar legislation on these issues, and we strongly urge the Senate to pass the Promise for Antibiotics and Therapeutics for Health (PATH) Act, as well as legislation authorizing the use of PRRs in Medicare./p>
“Furthermore, the legislation includes support for capturing medical device information, known as unique device identifiers, in patients’ electronic health records. These codes identify the manufacturer and model of medical devices, such as artificial hips and heart valves, and are integral to building a robust postmarket surveillance system to improve device safety, track performance, locate recalled products, and improve care coordination among clinicians treating an individual.
"Pew—along with FDA, large hospital systems, surgeons, patients, and other key health care stakeholders—have all supported the inclusion of these identifiers in patients’ health records. In addition to documenting identifiers in patients’ records, improving device surveillance requires the addition of these codes to insurance claims, which would create a large database for analyses of product performance.
“These policy solutions are endorsed by a large and diverse group of stakeholders and are imperative to protecting the health of the public. We look forward to ongoing collaboration with stakeholders and policymakers who share Pew’s sense of urgency on the issues of antibiotic resistance, prescription drug abuse, and medical device safety.
The Pew Charitable Trusts is driven by the power of knowledge to solve today’s most challenging problems. Learn more at www.pewtrusts.org