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This Viewpoint explains how a recent Supreme Court decision clarifies rules for prescribing controlled substances so that patients are not denied appropriate care and physicians are not unjustly prosecuted.

This medical news feature discusses the challenges of treating pregnant patients diagnosed with cancer following the reversal of Roe v Wade.

This study assesses changes in abortions performed and at what gestational age following a Texas order postponing non–medically necessary surgeries due to the COVID-19 pandemic compared with abortions performed during the same months in 2019.

This Viewpoint discusses the importance of preventive measures and supplies to reduce workplace COVID-19 transmission and calls for the US Occupational Safety a

The Centers for Disease Control and Prevention (CDC) recommends cloth face coverings in public settings to prevent spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (COVID-19). Face coverings decrease the amount of infectious virus exhaled into the environment, reducing the risk an exposed person will become infected.1 Although many states and localities have ordered mask use, considerable variability and inconsistencies exist. Would a national mandate be an effective COVID-19 prevention strategy, and would it be lawful? Given the patchwork of state pandemic responses, should the CDC have enhanced funding and powers to forge a nationally coordinated response to COVID-19 and to future health emergencies?

The confluence of coronavirus disease 2019 (COVID-19) and seasonal influenza this fall and winter will result in considerable morbidity and mortality, stressing the health system. With more than 100 000 COVID-19–related deaths already, the US could see a second wave of disease later this year. In 2018-2019 (a “moderate” year for influenza), the US experienced 35.5 million influenza cases, with 490 600 hospitalizations and 34 200 deaths related to influenza.1 An effective COVID-19 vaccine is unlikely until 2021. Even though seasonal influenza vaccines have variable year-to-year effectiveness, they can significantly reduce morbidity and mortality, especially with high coverage. The health system, and wider society, must prepare for the likelihood of co-epidemics of COVID-19 and influenza. What are the most effective strategies for increasing influenza vaccine coverage across the population and particularly in schools, businesses, and hospitals? Should states or businesses require vaccinations? Influenza vaccination, moreover, could offer valuable lessons for ensuring vaccine acceptance and uptake when COVID-19 vaccines become available.

The president and all 50 governors have declared health emergencies to combat the spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which causes coronavirus disease 2019 (COVID-19). While researchers race for vaccines, officials are implementing physical distancing, including orders to stay at home, restrict travel, and close non-essential businesses. To limit cross-border spread, a few states have issued mandatory quarantines for interstate travelers. Models suggest physical distancing would have to persist for 3 months to mitigate peak impacts on health systems and could continue on an intermittent basis for 12-18 months. What legal powers do governments have? What is the role of the courts? How can we balance public health with personal and economic rights?

This study uses data from the Connecticut Public Utilities Regulatory Authority to describe trends in medical exemptions from utility disconnection and characteristics and health care use of adults applying for such exemptions at a Yale New Haven Hospital care practice between 2011 and 2017.

Importance US law requires testing of new drugs before approval to ensure that they provide a well-defined benefit that is commensurate with their risks. A major challenge for the US Food and Drug Administration (FDA) is to achieve an appropriate balance between rigorous testing and the need for timely approval of drugs that have benefits that outweigh their risks. Objective To describe the evolution of laws and standards affecting drug testing, the use of new approval programs and standards, expansions of the role and authority of the FDA, and changes in the number of drugs approved from the 1980s to 2018. Evidence Sources of evidence included principal federal laws and FDA regulations (1962-2018) and FDA databases of approved new drugs (1984-2018), generic drugs (1970-2018), biologics (1984-2018), and vaccines (1998-2018); special development and approval programs (Orphan drug [1984-2018], Fast-Track [1988-2018], Priority Review and its predecessors [1984-2018], Accelerated Approval [1992-2018], and Breakthrough Therapy [2012-2018]); expanded access (2010-2017) and Risk Evaluation and Mitigation Strategies (2008-2018); and user fees paid to the FDA by industry (1993-2018). Findings From 1983 to 2018, legislation and regulatory initiatives have substantially changed drug approval at the FDA. The mean annual number of new drug approvals, including biologics, was 34 from 1990-1999, 25 from 2000-2009, and 41 from 2010-2018. New biologic product approvals increased from a median of 2.5 from 1990-1999, to 5 from 2000-2013, to 12 from 2014-2018. The median annual number of generic drugs approved was 136 from 1970 to the enactment of the Hatch-Waxman Act in 1984; 284 from 1985 to the enactment of the Generic Drug User Fee Act in 2012; and 588 from 2013-2018. Prescription drug user fee funding expanded from new drugs and biologics in 1992 to generic and biosimilar drugs in 2012. The amount of Prescription Drug User Fee Act fees collected from industry increased from an annual mean of $66 million in 1993-1997 to $820 million in 2013-2017, and in 2018, user fees accounted for approximately 80% of the salaries of review personnel responsible for the approval of new drugs. The proportion of drugs approved with an Orphan Drug Act designation increased from 18% (55/304) in 1984-1995, to 22% (82/379) in 1996-2007, to 41% (154/380) in 2008-2018. Use of Accelerated Approval, Fast-Track, and Priority Review for new drugs has increased over time, with 81% (48/59) of new drugs benefiting from at least 1 such expedited program in 2018. The proportion of new approvals supported by at least 2 pivotal trials decreased from 80.6% in 1995-1997 to 52.8% in 2015-2017, based on 124 and 106 approvals, respectively, while the median number of patients studied did not change significantly (774 vs 816). FDA drug review times declined from more than 3 years in 1983 to less than 1 year in 2017, but total time from the authorization of clinical testing to approval has remained at approximately 8 years over that period. Conclusions and Relevance Over the last 4 decades, the approval and regulation processes for pharmaceutical agents have evolved and increased in complexity as special programs have been added and as the use of surrogate measures has been encouraged. The FDA funding needed to implement and manage these programs has been addressed by expanding industry-paid user fees. The FDA has increasingly accepted less data and more surrogate measures, and has shortened its review times.

This study estimates what 2020 national US savings would have been using international reference pricing rather than US manufacturer and net prices for insulins and 50 top brand-name drugs.

Importance US law generally requires testing of high-risk medical devices prior to approval, as well as premarket evaluation of moderate-risk medical devices, with the goal of ensuring that the benefits of these products exceed their risks. The US Food and Drug Administration (FDA) attempts to balance the need for evidence generation with an approval process that facilitates access and encourages innovation. Objective To review the development of laws and standards affecting the evaluation and oversight of medical devices by the US regulatory system and the outcomes of this system from 1976 to 2020. Evidence Review Laws enacted by US Congress and regulations promulgated by the FDA through 2020; databases maintained by the FDA of device authorizations from 1976 to 2020; and annual reports of user fees paid to the FDA by industry. Findings Since Congress and the FDA initiated premarket review of medical devices in 1976, some fundamental innovations in the device regulation system have included special pathways to accelerate availability of investigational devices, more flexible evidence and review requirements, and increased funding to the FDA through industry-paid user fees. From 1987 to 2020, the annual number of novel devices granted premarket approval (which excludes supplements) ranged from 8 to 56 (median, 32), and the number of clearances for 510(k) devices (those that are “substantially equivalent” to marketed devices) ranged from 2804 to 5762 (median, 3404). User fee funding for devices was established in 2002 and annual fees collected increased from $30 million in 2003 (in 2019 dollars) to more than $208 million in 2019; this represented 43% of FDA funding related to the review of medical devices. Although many new devices have led to considerable patient benefit, such as hypodermic needles and magnetic resonance imaging machines, important adverse events caused by some devices, such as an implanted device for birth control and a surgical mesh implant for pelvic organ prolapse, have led to calls to reexamine the regulatory system for such products. Conclusions and Relevance Over the last 45 years, medical device regulation has become more complex, with more regulatory pathways and greater variations in the evidence and controls required for authorization. Increased FDA support from industry and concern about flexible authorization requirements reflect the tension between efficient access and the need for assurances that products will safely benefit patients.

This study uses Department of Health and Human Services data to analyze surveillance of electronic health records for patient safety issues to identify those with a potential for patient harm, and the frequency of these issues.