JAMA Health Forum最新文献

Importance: Manufacturers of drug-device combinations, such as inhalers and injectable medications, often obtain patents not just on the active pharmaceutical ingredients of these products (primary patents) but also on other features, such as their formulations and methods of use (secondary patents) and delivery devices (tertiary patents). Courts, policymakers, and regulators have recently begun scrutinizing whether manufacturers may be improperly listing tertiary patents with the Food and Drug Administration (FDA) that lack claims on active pharmaceutical ingredients and whether such patents may be delaying generic competition. However, the full scope of patenting practices on drug-device combinations remains unknown.

Objective: To analyze patent protection on small-molecule drugs approved by the FDA from 1986 to 2023 with 1 or more tertiary patents.

Design, setting, and participants: In this retrospective cohort study of patenting practices on drug-device combinations, all patents listed in the FDA's Approved Drug Products With Therapeutic Equivalence Evaluations (Orange Book) were categorized (primary, secondary, or tertiary), and products with at least 1 tertiary patent were included. Analyses were performed between May 2024 and October 2025.

Main outcomes and measures: The primary outcome of the study was the duration of expected patent protection on each product, measured from the time of approval until expiration of the last-to-expire patent. Added protection from tertiary patents that went beyond protection afforded by primary or secondary patents was also analyzed.

Results: The FDA approved 331 products from 1986 to 2023 with 1 or more tertiary patents; 137 of 3241 patents (4.2%) listed on these products were primary patents, 1353 of 3241 were secondary patents (41.7%), and 1751 of 3241 were tertiary patents (54.0%). Among tertiary patents, 1047 of 1751 (59.8%) lacked claims making any mention of active pharmaceutical ingredients. The median (IQR) duration of expected patent protection among products in the cohort was 17.6 (14.4-21.2) years. There were 180 products (54.4%) that had tertiary patents extending periods of expected protection beyond other patents, and the median (IQR) duration of added protection was 7.5 (2.8-13.9) years.

Conclusions and relevance: The findings of this cohort study suggest that policymakers and regulators should take steps to ensure that tertiary patents are not improperly listed in the Orange Book and that generic competition occurs in a timely fashion.

Importance: Twenty-seven states have enacted targeted regulation of abortion providers (TRAP) laws that may disproportionately affect higher-risk pregnancies such as those conceived through fertility treatment.

Objective: To assess the association of TRAP laws with the relative rates of adverse outcomes of pregnancies conceived through fertility treatment.

Design, setting, and participants: This cohort study of singleton births conceived through fertility treatment used National Vital Statistics System data on births between 2012 and 2021. Data were analyzed from August 15, 2024, to September 8, 2025.

Exposure: Included participants were categorized as either living under the legal jurisdiction of states with or without TRAP laws enacted during the study period. As laws were not passed in every state uniformly, the first year of enforcement was excluded.

Main outcomes and measures: Demographic characteristics of individuals who conceived with fertility treatments living in states with and without TRAP laws were compared using χ2 and analysis of variance tests. A maternal composite of adverse outcomes was constructed. Secondary outcomes included a neonatal composite of adverse outcomes and rate of preterm birth. Controlling for potential confounders, generalized estimating equation models with binomial distribution, identity link, and robust sandwich SE estimators were used to assess adjusted absolute percentage point differences comparing states with and without TRAP laws across the enactment of TRAP laws.

Results: This study included 416 019 singleton births (mean [SD] maternal age, 34.5 [5.3] years; mean [SD] gestational age, 38.3 [2.4] weeks; 213 294 males [51.3%]) conceived with fertility treatment. Of these births, 174 671 (42.0%) occurred in states with TRAP laws and 241 348 (58.0%) in states without these laws. Generalized estimating equation models demonstrated a greater increase in the composite of adverse maternal outcomes (absolute adjusted difference-in-differences, 0.25; 95% CI, 0.003-0.50) in states with TRAP laws relative to states without.

Conclusions and relevance: These findings suggest an increase in maternal morbidity among patients using fertility care in states that passed TRAP laws relative to states that did not.

Importance: Public health decisions increasingly rely on large-scale data and emerging technologies such as artificial intelligence and mobile health. However, many populations-including those in rural areas, with disabilities, experiencing homelessness, or living in low- and middle-income regions of the world-remain underrepresented in health datasets, leading to biased findings and suboptimal health outcomes for certain subgroups. Addressing data inequities is critical to ensuring that technological and digital advances improve health outcomes for all.

Observations: This article proposes 10 core concepts to improve data equity throughout the operational arc of data science research and practice in public health. The framework integrates computer science principles such as fairness, transparency, and privacy protection, with best practices in public health data science that focus on mitigating information and selection biases, learning causality, and ensuring generalizability. These concepts are applied together throughout the data life cycle, from study design to data collection, analysis, and interpretation to policy translation, offering a structured approach for evaluating whether data practices adequately represent and serve all populations.

Conclusions and relevance: Data equity is a foundational requirement for producing trustworthy inference and actionable evidence. When data equity is built into public health research from the start, technological and digital advances are more likely to improve health outcomes for everyone rather than widening existing health gaps. These 10 core concepts can be used to operationalize data equity in public health. Although data equity is an essential first step, it does not automatically guarantee information, learning, or decision equity. Advancing data equity must be accompanied by parallel efforts in information theory and structural changes that promote informed decision-making.

Importance: Housing cost burden is at an all-time high in the US and may disproportionately affect health outcomes among low-income populations. Medicaid-insured individuals and those diagnosed with cardiovascular (CV) disease, such as heart failure (HF), may be especially at increased risk of adverse health outcomes associated with housing cost burden.

Objective: To assess the association between area-level housing cost burden and the probability of CV-related hospitalization or emergency department (ED) visits among Medicaid beneficiaries aged 19 to 64 years with HF.

Design, setting, and participants: This cross-sectional study used individual-level health care utilization data obtained from the Transformed Medicaid Statistical Information System Analytic Files (2018-2019). All zip codes in the US with resident Medicaid beneficiaries aged 19 to 64 years who had a preexisting diagnosis of HF and were continuously enrolled in 2019 were included except for those in Alabama, Rhode Island, and Utah due to data quality issues. Data were analyzed from October 2024 to October 2025.

Exposure: Area-level housing cost burden was defined as the zip code-level proportion of housing units occupied by individuals with an annual household income less than $35 000 who spent 30% or more of their income on housing costs.

Main outcomes and measures: The probability of a CV-related hospitalization and of a CV-related ED visit in 2019. Generalized estimating equation models were used to evaluate the association between housing cost burden and outcomes after adjusting for individual and area-level factors.

Results: This study included 233 195 individuals (mean [SD] age, 51.5 [9.6] years, 107 447 female [46.1%]) who were living in 19 577 zip codes. The mean (SD) zip code housing cost burden was 67.4% (16.5%). In 2019, 42 886 beneficiaries (18.4%) had at least 1 CV-related hospitalization and 75 392 (32.3%) had an ED visit. After covariate adjustment, a 10-percentage point increase in housing cost burden was associated with higher odds of CV-related hospitalizations (odds ratio [OR], 1.03; 95% CI, 1.01-1.06) and ED visits (OR, 1.03; 95% CI, 1.01-1.04). There were also higher odds of HF-related hospitalizations (OR, 1.04; 95% CI, 1.01-1.07).

Conclusions and relevance: The findings of this study suggest that area-level housing cost burden may be associated with outcomes among Medicaid beneficiaries with HF and highlights the need to investigate whether strategies that address housing affordability can play a role in improving health outcomes in this population.