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With continued community transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in the US, there has been sustained focus on the role of testingtomitigateandsuppressspread.Afterthefirstcase of coronavirus disease 2019 (COVID-19) was diagnosed in the US in mid-January 2020, testing lagged behind due to challenges with test validation at the Centers for Disease Control and Prevention. In late February 2020, the US Food and Drug Administration (FDA) eased its restrictions on Emergency Use Authorization, which led to a rapid increase in the number of authorized tests. By May 2020, the private sector was performing 99% of US COVID-19 testing. By August 2020, the number of SARS-CoV-2 tests peaked and then plateaued at approximately 1 million tests per day. Multiple parallel efforts to bring diagnostic innovation to COVID-19 testing are underway and are likely to result in more tests as well as new innovative platforms. For instance, the Rapid Acceleration of Diagnostics program is a $1.5-billion US government program launched by the National Institutes of Health to support development, production scale-up, and deployment of rapid tests with a goal of 6 million tests available per day. 1

949s o u n d i n g b o a r d T h e n e w e ng l a n d j o u r na l o f m e dic i n e ELECTION 2012In this election year, U.S. national spending on health care will reach $2.8 trillion, or about 18% of total spending on all goods and services. This high level of spending reduces our ability to invest in other important parts of the economy and also adds to our unsustainable national debt. There is wide agreement that we must find ways to bend the health care cost curve. Taking different approaches, the two articles that follow present a range of options, including reducing both the prices and quantity of services for public and private payers, reducing administrative costs, implementing new market-based incentives, and reforming the tax subsidy for employer-sponsored health insurance. It is our hope that these articles will stimulate discussion and debate on the best ways to address the cost problem and to place our health care system on a more sustainable path.

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IMPORTANCE Transmucosal immediate-release fentanyls (TIRFs), indicated solely for breakthrough cancer pain in opioid-tolerant patients, are subject to a US Food and Drug Administration (FDA) Risk Evaluation and Mitigation Strategy (REMS) to prevent them from being prescribed inappropriately. OBJECTIVES To evaluate knowledge assessments of pharmacists, prescribers, and patients regarding appropriate TIRF use; to describe sponsor assessments, based on claims data, of whether the REMS program was meeting its goals; and to characterize how the FDA responded to REMS assessments. DESIGN, SETTING, AND PARTICIPANTS Qualitative analysis of 4877 pages of FDA documents obtained through a Freedom of Information Act request, including 6 annual REMS assessment reports (2012-2017), FDA evaluations of these reports, and FDA-sponsor correspondence about safety issues. EXPOSURE A REMS program to reduce the risk of adverse outcomes, including misuse, abuse, addiction, and overdose, arising from use of TIRFs. MAIN OUTCOMES AND MEASURES (1) Knowledge assessments of pharmacists, prescribers, and patients; (2) survey and claims-based prescribing assessments; (3) FDA and TIRF sponsor communications; (4) modifications to the REMS program; and (5) disenrollment of noncompliant prescribers. RESULTS Twelve months after initiation of the program, 24 of 302 pharmacists (7.9%), 35 of 302 prescribers (11.6%), and 5 of 192 patients (2.6%) incorrectly reported that TIRFs can be prescribed to opioid-nontolerant patients, with similar levels of misunderstanding maintained in the subsequent reports. At 60 months, product-specific analyses of claims data indicated that between 34.6% and 55.4% of patients prescribed TIRFs were opioid-nontolerant. In the 48-month survey, 106 of 310 prescribers (34.2%) reported prescribing TIRFs for opioid-tolerant patients with chronic, noncancer pain; at 60 months, 54 of 302 prescribers (18.4%) and 148 of 310 patients (47.7%) erroneously reported that TIRFs were FDA-approved for such use. Over the 60-month period examined, there were few substantive changes made to the REMS to address evidence of high rates of off-label TIRF use, and, although the REMS program had a noncompliance plan, there was no report of prescribers being disenrolled for inappropriate prescribing. CONCLUSIONS AND RELEVANCE In this review of FDA documents pertaining to the TIRF REMS, surveys of pharmacists, prescribers, and patients reflected generally high levels of knowledge regarding proper TIRF prescribing, yet some survey items as well as claims-based analyses indicated substantial rates of inappropriate TIRF use. Despite these findings, the FDA did not require substantive changes to the program.