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1.
Biol Pharm Bull ; 47(3): 611-619, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38479885

RESUMO

The addition of clinically significant adverse reactions (CSARs) to Japanese package inserts (PIs) is an important safety measure that can be used to inform medical personnel of potential health risks; however, determining the necessity of their addition can be lengthy and complex. Therefore, we aimed to construct a machine learning-based model that can predict the addition of CSARs at an early stage due to the accumulation of both Japanese and overseas adverse drug reaction (ADR) cases. The target comprised CSARs added to PIs from August 2011 to March 2022. The control group consisted of drugs without the same CSARs in their PIs by March 2022. Features were generated using ADR case accumulation data obtained from the Japanese Adverse Drug Event Report and the U.S. Food and Drug Administration Adverse Event Reporting System databases. The model was constructed using DataRobot, and its performance evaluated using the Matthews correlation coefficient. The target for the addition of CSARs included 414 cases, comprising 302 due to domestic case accumulation, 22 due to both domestic and overseas case accumulation, 12 due to overseas case accumulation, and 78 due to revisions of the company core data sheet. The best model was a generalized linear model with informative features, achieving a cross-validation of 0.8754 and a holdout of 0.8995. In conclusion, the proposed model effectively predicted CSAR additions to PIs resulting from the accumulation of ADR cases using data from both Japan and the United States.


Assuntos
Rotulagem de Medicamentos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Humanos , Estados Unidos , Japão , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Preparações Farmacêuticas , Sistemas de Notificação de Reações Adversas a Medicamentos
2.
Pharmacoepidemiol Drug Saf ; 33(3): e5766, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38418933

RESUMO

PURPOSE: To explore how boxed warning (BW) information fits within the context of prescribers' overall treatment decision-making and communication with patients. METHODS: In-depth interviews (N = 52) were conducted with primary care providers and specialists. Participants were presented with one of two prescribing scenarios: (1) estrogen vaginal inserts to treat vulvovaginal atrophy (VVA) associated with menopause; or (2) direct-acting antivirals (DAA) to treat chronic hepatitis C virus infection (HCV). The semi-structured interviews explored participants' treatment decision-making within the scenario, reactions to current prescribing information for a product within the FDA-approved drug class, as well as their perceptions of BWs generally. RESULTS: Across scenarios, providers described that the BW is only one of several factors that influence treatment decision-making. In the VVA scenario, symptom severity, family history, and experience with nonprescription drugs were raised as common factors that influence prescribing considerations; compared to comorbid infections, viral load, and HCV genotype in the HCV scenario. Perceptions of the DAA BW were generally positive or neutral, as many participants found the information important and appropriate. The VVA BW was viewed less favorably, with many participants stating the BW overstates the risk for this drug. CONCLUSIONS: Findings suggest that BWs are one of several factors that influence providers' treatment decisions, and BW influence largely depends on context. Providers across scenarios expressed notable differences in their perceptions of the risk information provided in the presented BWs; however, across scenarios participants expressed consideration of how patients may perceive the BW.


Assuntos
Antivirais , Hepatite C Crônica , Feminino , Humanos , Estados Unidos , Rotulagem de Medicamentos , Hepatite C Crônica/tratamento farmacológico , Pesquisa Qualitativa , United States Food and Drug Administration
3.
JAMA ; 331(10): 818-820, 2024 03 12.
Artigo em Inglês | MEDLINE | ID: mdl-38381427

RESUMO

This Medical News article discusses the US Food and Drug Administration's new boxed warning requirement and investigation of secondary malignancies after CAR T-cell therapy.


Assuntos
Rotulagem de Medicamentos , Imunoterapia Adotiva , Segunda Neoplasia Primária , Humanos , Imunoterapia Adotiva/efeitos adversos , Segunda Neoplasia Primária/etiologia , Estados Unidos , United States Food and Drug Administration
4.
JAMA ; 331(11): 974-976, 2024 03 19.
Artigo em Inglês | MEDLINE | ID: mdl-38393714

RESUMO

This study examines the accuracy of labeling for galantamine products formulated as both generic drugs and dietary supplements, as well as tests for contamination with microorganisms.


Assuntos
Suplementos Nutricionais , Rotulagem de Medicamentos , Medicamentos Genéricos , Galantamina , Contaminação de Medicamentos , Rotulagem de Medicamentos/normas
5.
JMIR Public Health Surveill ; 10: e49755, 2024 Jan 30.
Artigo em Inglês | MEDLINE | ID: mdl-38289650

RESUMO

BACKGROUND: Drug-induced suicide (DIS) is a severe adverse drug reaction (ADR). Although clinical trials have provided evidence on DIS, limited investigations have been performed on rare ADRs, such as suicide. OBJECTIVE: We aimed to systematically review case reports on DIS to provide evidence-based drug information. METHODS: We searched PubMed to obtain case reports regarding DIS published until July 2021. Cases resulting from drugs that are no longer used or are nonapproved, substance use, and suicidal intentions were excluded. The quality of each case report was assessed using the CASE (Case Reports) checklist. We extracted data regarding demographics, medication history, suicide symptoms, and symptom improvement and evaluated the causality of DIS using the Naranjo score. Furthermore, to identify the potential suicidal risk of the unknown drugs, we compared the results of the causality assessment with those of the approved drug labels. RESULTS: In 83 articles, we identified 152 cases involving 61 drugs. Antidepressants were reported as the most frequent causative drugs of DIS followed by immunostimulants. The causality assessment revealed 61 cases having possible, 89 cases having probable, and 2 cases having definite relationships with DIS. For approximately 85% of suspected drugs, the risk of suicidal ADRs was indicated on the approved label; however, the approved labels for 9 drugs, including lumacaftor/ivacaftor, doxycycline, clozapine, dextromethorphan, adalimumab, infliximab, piroxicam, paclitaxel, and formoterol, did not provide information about these risks. CONCLUSIONS: We found several case reports involving drugs without suicide risk information on the drug label. Our findings might provide valuable insights into drugs that may cause suicidal ADRs.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Suicídio , Humanos , Doxiciclina , Rotulagem de Medicamentos , Ideação Suicida , Relatos de Casos como Assunto
6.
Eur J Clin Pharmacol ; 80(4): 575-588, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38282080

RESUMO

Medication errors are one of the biggest problems in healthcare. The medicines' poor labelling design (i.e. look-alike labels) is a well-recognised risk for potential confusion, wrong administration, and patient damage. Human factors and ergonomics (HFE) encourages the human-centred design of system elements, which might reduce medication errors and improve people's well-being and system performance. OBJECTIVE: The aim of the present study is twofold: (i) to use a human reliability analysis technique to evaluate a medication administration task within a simulated scenario of a neonatal intensive care unit (NICU) and (ii) to estimate the impact of a human-centred design (HCD) label in medication administration compared to a look-alike (LA) label. METHOD: This paper used a modified version of the human error assessment and reduction technique (HEART) to analyse a medication administration task in a simulated NICU scenario. The modified technique involved expert nurses quantifying the likelihood of unreliability of a task and rating the conditions, including medicine labels, which most affect the successful completion of the task. RESULTS: Findings suggest that error producing conditions (EPCs), such as a shortage of time available for error detection and correction, no independent checking of output, and distractions, might increase human error probability (HEP) in administering medications. Results also showed that the assessed HEP and the relative percentage of contribution to unreliability reduced by more than 40% when the HCD label was evaluated compared to the LA label. CONCLUSION: Including labelling design based on HFE might help increase human reliability when administering medications under critical conditions.


Assuntos
Unidades de Terapia Intensiva Neonatal , Erros de Medicação , Recém-Nascido , Humanos , Reprodutibilidade dos Testes , Preparações Farmacêuticas , Rotulagem de Medicamentos/métodos
7.
Pharmacogenomics J ; 24(1): 2, 2024 Jan 17.
Artigo em Inglês | MEDLINE | ID: mdl-38233388

RESUMO

This work aimed to analyse the pharmacogenetic information in the Spanish Drug Regulatory Agency (AEMPS) Summary of Products Characteristics (SmPC), evaluating the presence of pharmacogenetic biomarkers, as well as the associated recommendations. A total of 55.4% of the 1891 drug labels reviewed included information on pharmacogenetic biomarker(s). Pharmacogenomic information appears most frequently in the "antineoplastic and immunomodulating agents", "nervous system", and "cardiovascular system" Anatomical Therapeutic Chemical groups. A total of 509 different pharmacogenetic biomarkers were found, of which CYP450 enzymes accounted for almost 34% of the total drug-biomarker associations evaluated. A total of 3679 drug-biomarker pairs were identified, 102 of which were at the 1A level (PharmGKB® classification system), and 33.33% of these drug-pharmacogenetic biomarker pairs were assigned to "actionable PGx", 12.75% to "informative PGx", 4.9% to "testing recommended", and 4.9% to "testing required". The rate of coincidence in the assigned PGx level of recommendation between the AEMPS and regulatory agencies included in the PharmGKB® Drug Label Annotations database (i.e., the FDA, EMA, SWISS Medic, PMDA, and HCSC) ranged from 45% to 65%, being 'actionable level' the most frequent. On the other hand, discrepancies between agencies did not exceed 35%. This study highlights the presence of relevant pharmacogenetic information on Spanish drug labels, which would help avoid interactions, toxicity, or lack of treatment efficacy.


Assuntos
Antineoplásicos , Farmacogenética , Humanos , Biomarcadores , Resultado do Tratamento , Rotulagem de Medicamentos , Testes Farmacogenômicos
9.
Res Social Adm Pharm ; 20(2): 75-85, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-38030546

RESUMO

INTRODUCTION: Written instructive information for the patient is key in pharmaceutical care. However, the preexisting literature agrees on the discordance between the readability of written medication messages intended for patients. The aim of our work was to systematically review the available evidence on the effect of pharmaceutical pictograms as elements that facilitate understanding of the text in primary or secondary medication packaging. METHODS: A parallel systematic search was conducted of the literature covering evidence of the effect of including pictograms in primary or secondary packaging on comprehension by potential users or caregivers up to April 9, 2023. The databases consulted were Scopus, MEDLINE and Web of Science. Only randomized controlled studies, whose main outcome measure was comprehension, were included. RESULTS: Only 8 papers met our search criteria. In most of the included studies, the intervention of including pictograms improved participants' performance in comprehending instructions. A debatable methodological quality, and differences in the target population, textual complexity of the materials or the cultural affinity of the pictograms with the target population in each study, could have had a decisive influence on the results. CONCLUSION: The heterogeneity in the design of each study poses a significant barrier to establishing commonalities and generalizing the results. This heterogeneity also prevented us from conclusively confirming the usefulness of pictograms complementary to instructional text in improving the comprehension of instructions for the rational use of medicines.


Assuntos
Compreensão , Rotulagem de Medicamentos , Letramento em Saúde , Humanos , Embalagem de Medicamentos , Preparações Farmacêuticas
11.
Clin Pharmacol Ther ; 115(1): 22-24, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-37873843

RESUMO

Patents prevent generic drug entry. Brand firms file new "method of use" patents for old drugs to prevent generic entry. Congress addressed this issue by creating the "skinny label" pathway, which allows generic firms to use the drug label to indicate that the old drug can only be used for non-patented uses. This pathway is now in jeopardy due to a recent court case. This paper outlines the issues and suggests possible legislative solutions.


Assuntos
Indústria Farmacêutica , Medicamentos Genéricos , Humanos , Estados Unidos , Rotulagem de Medicamentos , Legislação de Medicamentos , Custos de Medicamentos
12.
Ther Innov Regul Sci ; 58(2): 357-367, 2024 03.
Artigo em Inglês | MEDLINE | ID: mdl-38135862

RESUMO

PURPOSE: To develop a machine learning (ML)-based model for predicting the addition of clinically significant adverse reaction (CSAR)-associated information to drug package inserts (PIs) based on information of adverse drug reaction (ADR) cases during the post-marketing stage in Japan. METHODS: We collected data on CSARs added to PIs from August 2011 to March 2020. ADR cases that led to CSARs resulting in PI revisions were considered as a positive case, and ML was used to construct a binary classification model to predict the PI revisions. We selected 34 features based on the ADR aggregate data collected 6 months before PI revisions. Prediction performance was evaluated using the Matthews correlation coefficient (MCC). RESULTS: We found CSAR information added to PIs in 617 cases, 334 of which were due to the accumulation of domestic cases, and used only domestic case data for the prediction model. Among prediction models developed using several kinds of algorithms, the support vector machine with the radial basis function kernel with feature selection showed the highest predictive performance, having an MCC of 0.938 for the cross-validation and 0.922 for the test dataset. The feature with the highest importance in the model was the "average number of patients reported per quarter." CONCLUSION: Our model accurately predicted PI revisions using information on ADR cases that occurred 6 months before. This is the first ML model that can predict the necessary safety measures and is an efficient method for guiding the decision to adopt additional safety measures early.


Assuntos
Rotulagem de Medicamentos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Humanos , Japão , Aprendizado de Máquina , Algoritmos
13.
Pharm. care Esp ; 25(6): 4-14, 15-12-2023. ilus, tab, graf
Artigo em Espanhol | IBECS | ID: ibc-228634

RESUMO

Introducción: La Atención Farmacéutica requiere que los pacientes comprendan la información brindada. La inclusión de ayudas visuales podría mejorar la comprensión de textos complejos como son los prospectos de los medicamentos. Nuestro objetivo fue evaluar los efectos de la inclusión de pictogramas farmacéuticos sobre la comprensión de instrucciones elementales para el uso de medicamentos por estudiantes que finalizan la enseñanza básica. Método: De un total de 309 alumnos participantes, se aleatorizaron 160 para leer tres prospectos de medicamentos de uso frecuente (ibuprofeno, amoxicilina/ácido clavulánico y omeprazol), mientras que 149 recibieron pictogramas junto a los prospectos. La aleatorización fue alterna según la posición de los alumnos en el aula. La comprensión fue estimada mediante cuestiones básicas del uso de medicamentos. Resultados: En el grupo control solo el 38.75% de los alumnos contestaron correctamente cuándo tomar el ibuprofeno en relación a las comidas el 32.25% acertaron cual es la dosis habitual del antibiótico y el 61.88% identificó la indicación del omeprazol. En los tres casos, se encontraron diferencias significativas en favor de la comprensión en el grupo experimental (OR = 1.93; 95% IC, 1.23 – 3.05; p = 0.0041, OR = 3.87; 95% IC, 2.43 – 6.25; p = 10-7 y OR = 3.55; 95% IC, 2.07 – 6.29; p = 3.67x10-5 respectivamente). Conclusiones: La inclusión de pictogramas farmacéuticos en los prospectos es una estrategia sencilla que podría potencialmente favorecer el uso racional del medicamento. (AU)


Introduction: Pharmaceutical Care requires that patients understand the information provided. The inclusion of visual aids could improve the comprehension of complex texts such as drug package inserts. Our objective was to evaluate the effects of the inclusion of pharmaceutical pictograms on the comprehension of elementary instructions for the use of drugs by students completing basic education. Methods: Among a total of 309 participating students, 160 were randomized to read three frequently used drug package inserts (ibuprofen, amoxicillin/clavulanic acid and omeprazole), while 149 received pictographs together with the package inserts. Randomization was alternated according to the position of the students in the classroom. Comprehension was estimated by means of basic questions on the use of drugs. Results: In the control group only 38.75% of the students answered correctly when to take ibuprofen in relation to meals, 32.25% were right about the usual dose of the antibiotic and 61.88% identified the indication for omeprazole. In all three cases, significant differences in favor of understanding were found in the experimental group (OR = 1.93; 95% CI, 1.23 - 3.05; p = 0.0041, OR = 3.87; 95% CI, 2.43 - 6.25; p = 10-7 and OR = 3.55; 95% CI, 2.07 - 6.29; p = 3.67x10-5 respectively). Conclusions: The inclusion of pharmaceutical pictograms in package inserts is a simple strategy that could favor potentially the rational use of drugs. (AU)


Assuntos
Humanos , Adolescente , Letramento em Saúde , Rotulagem de Medicamentos , Medicamentos sem Prescrição , Recursos Audiovisuais/tendências
14.
J Clin Pharmacol ; 63 Suppl 2: S18-S24, 2023 11.
Artigo em Inglês | MEDLINE | ID: mdl-37942908

RESUMO

Pediatric obesity is a global public health concern. Obesity-related physiological changes may affect the pharmacokinetics of drugs and lead to therapeutic failure or toxicities. An earlier review of pediatric drug development programs from 2007 to 2016 found that, of 89 programs listing obesity-related terms, only 4 (4%) products described pharmacokinetic changes associated with obesity. This review examined obesity considerations for 185 drug products for which pediatric drug development programs were submitted to the US Food and Drug Administration (FDA) between 2016 and 2021. The FDA-authored review documents and drug product labeling were queried for obesity-related terms and the review found 97/185 (52%) drug products had obesity-related terms in these sources. Of the 97 drug products, 55/97 (57%) had obesity-related terms in the FDA-authored reviews only, 13/97 (13%) had obesity-related terms in the drug product labeling only, and 29/97 (30%) had obesity-related terms in both FDA-authored reviews and drug product labeling. Most of the obesity-related information in the drug product labeling originated from data collected from adults. Only 13/185 (7%) drug product labeling contained obesity-related terms in reference to drug pharmacokinetics. Specific dosage recommendations for the use of the drug products in pediatric patients who are obese remain lacking. The dearth of available information to guide drug dosages in the obese pediatric population suggests that further research, innovative approaches, and evidence-based guidelines are needed to inform the optimal therapeutic use of drugs in this population.


Assuntos
Desenvolvimento de Medicamentos , Obesidade Pediátrica , Adulto , Estados Unidos , Criança , Humanos , Preparações Farmacêuticas , Obesidade Pediátrica/tratamento farmacológico , Rotulagem de Medicamentos , United States Food and Drug Administration
15.
Healthc Policy ; 19(1): 65-70, 2023 08.
Artigo em Inglês | MEDLINE | ID: mdl-37695708

RESUMO

Building upon the article by Moore Hepburn et al. (2023), this rejoinder acts to reinforce the inadequacy of current drug labelling laws and the urgency of the need for improved paediatric drug regulation in Canada. To facilitate a path forward, specific examples of success in other trusted foreign jurisdictions are provided. A call to educate parents and the public about the current lack of paediatric drug labelling and the ways that multi-stakeholder groups can work together to ensure safe and effective pharmacotherapy for Canadian children are highlighted.


Assuntos
Rotulagem de Medicamentos , Internacionalidade , Humanos , Criança , Canadá
16.
Ther Innov Regul Sci ; 57(6): 1248-1259, 2023 11.
Artigo em Inglês | MEDLINE | ID: mdl-37592154

RESUMO

BACKGROUND: Look-alike sound-alike (LASA) medications have similar pronunciation (phonetic) and/or manifestation (orthographic), which could create confusion among users and challenge the safe use of medicines. The availability of foreign products in local markets aggravates the situation. This study was designed to examine the registered medicine proprietary names in Sri Lanka to discern the presence of similar medicine names in the industry. METHODS: A cross-sectional study was conducted on the registered drug proprietary names in Sri Lanka. Using the RAND and RANK functions in Microsoft® excel® 365, a random sample of 385 proprietary names was selected. Two evaluators independently evaluated each proprietary name in the sample against the other registered proprietary names following a stepwise text filtering method. After each filter, the resulting proprietary names were manually examined for identical, similar-looking, and similar-sounding proprietary names to the name under evaluation. The observations were matched, categorized, and collated into ten groups. RESULTS: Among the 385 names evaluated, 138 (35.84%) proprietary names had no similarity to existing other registered proprietary names. The rest of the names (n = 247, 64.15%) were found to be either identical (n = 03 pairs), look-alike (n = 91 pairs), or sound-alike (n = 80 pairs) to the registered proprietary names. CONCLUSION: The findings revealed the presence of equal and similar proprietary names in the system. A multifactorial strategy led by the National Medicine Regulatory Authority (NMRA) is recommended to minimize the confusing names entering the system. Primarily the NMRA's call for action should include adequate industry guidance with specific guidelines, a significant pre-submission assessment process, and denying approval of LASA proprietary names.


Assuntos
Rotulagem de Medicamentos , Erros de Medicação , Humanos , Estudos Transversais , Sri Lanka
17.
Pharmacogenomics J ; 23(6): 149-160, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-37626111

RESUMO

Epilepsy treatment is challenging due to heterogeneous syndromes, different seizure types and higher inter-individual variability. Identification of genetic variants predicting drug efficacy, tolerability and risk of adverse-effects for anti-seizure medications (ASMs) is essential. Here, we assessed the clinical actionability of known genetic variants, based on their functional and clinical significance and estimated their diagnostic predictability. We performed a systematic PubMed search to identify articles with pharmacogenomic (PGx) information for forty known ASMs. Functional annotation of the identified genetic variants was performed using different in silico tools, and their clinical significance was assessed using the American College of Medical Genetics (ACMG) guidelines for variant pathogenicity, level of evidence (LOE) from PharmGKB and the United States-Food and drug administration (US- FDA) drug labelling with PGx information. Diagnostic predictability of the replicated genetic variants was evaluated by calculating their accuracy. A total of 270 articles were retrieved with PGx evidence associated with 19 ASMs including 178 variants across 93 genes, classifying 26 genetic variants as benign/ likely benign, fourteen as drug response markers and three as risk factors for drug response. Only seventeen of these were replicated, with accuracy (up to 95%) in predicting PGx outcomes specific to six ASMs. Eight out of seventeen variants have FDA-approved PGx drug labelling for clinical implementation. Therefore, the remaining nine variants promise for potential clinical actionability and can be improvised with additional experimental evidence for clinical utility.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Farmacogenética , Humanos , Estados Unidos , Rotulagem de Medicamentos , United States Food and Drug Administration
19.
Expert Rev Clin Immunol ; 19(11): 1385-1397, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37596779

RESUMO

INTRODUCTION: Janus kinase inhibitors (JAKi) have dramatically improved the treatment of various autoimmune and myeloproliferative disorders. Recently, concern has arisen regarding their safety in patients with rheumatoid arthritis. AREAS COVERED: Here, we provide a comprehensive summary of the major current and emerging JAKi and their indications, address recent studies on comparative safety, and provide insight into their future and use. We emphasize that the application of the research findings on a case-by-case basis should consider a patient's age, comorbidities, disease for which JAKi is being considered, disease activity, the JAKi target(s), alternate treatment options available for the patient, and the planned duration of JAKi. EXPERT OPINION: Rheumatologists are used to prescribing therapies in which a risk-to-benefit assessment is required as well as to screening and monitoring the safety of medications. Thus, rheumatologists are already practiced in applying specific criteria to effectively screen and monitor patients who are candidates for JAKi therapy. Ongoing research will help to clarify any mechanisms underlying differential safety signals between JAK and other therapies, what the balance between risk and efficacy is, who the susceptible subpopulations are, and whether safety signals are shared between different JAKis and across indications.


Assuntos
Antirreumáticos , Artrite Reumatoide , Inibidores de Janus Quinases , Humanos , Rotulagem de Medicamentos , Inibidores de Janus Quinases/efeitos adversos , Artrite Reumatoide/tratamento farmacológico , Antirreumáticos/efeitos adversos
20.
JAMA Health Forum ; 4(7): e231718, 2023 Jul 07.
Artigo em Inglês | MEDLINE | ID: mdl-37418270

RESUMO

Importance: The US Food and Drug Administration (FDA) often relies on independent advisory committees when making decisions about the approval of prescription drugs or their withdrawal from the market. These committees provide the FDA with valuable insight and an opportunity to build public trust through transparent deliberation, but recent controversies have raised questions about the optimal use of FDA advisory committees. Objective: To assess the frequency, purposes, and voting outcomes of human drug advisory committees convened from 2010 to 2021 and the FDA's corresponding actions. Design, Setting, and Participants: This qualitative study used a manual review of meeting summaries prepared by FDA staff for the 18 human drug advisory committees active at any time from January 1, 2010, to December 31, 2021, as well as FDA announcements and press releases, drug labels and approval data, industry publications, and company press releases. Main Outcomes and Measures: Outcomes of votes on regulatory questions were recorded using meeting minutes. Alignment of FDA action with advisory votes for new drugs and indications was judged as of 1 year after the vote was held and as of November 30, 2022. Results: The FDA held 409 human drug advisory committee meetings from 2010 to 2021. Committees were convened less frequently over time, from a high of 50 in 2012 to a low of 18 in 2020 and 2021. Much of this decrease occurred at committee meetings involving votes on initial approvals, which declined from a high of 26 in 2012 to a low of 8 in 2021. Overall, FDA regulatory actions aligned with 262 of 298 advisory committee votes on initial approvals, supplemental approvals, withdrawals of approval, and safety actions (88%). Approval followed 142 of 147 positive votes for initial approvals (97%) and 33 of 36 positive votes for supplemental indications (92%), while nonapproval followed 40 of 60 negative votes on initial approvals (67%) and 18 of 21 negative votes on supplemental indications (86%). Conclusions and Relevance: In this qualitative study, there was consistent alignment between advisory votes and FDA action across years and subject areas, but the number of meetings decreased over time. Discordance between FDA actions and advisory committee votes was most frequently an approval after a negative vote. This study demonstrated that these committees have played a key role in the FDA's decision-making process but that the FDA sought independent expert advice less frequently over time even as it continued to follow it. The role of advisory committees in the current regulatory landscape should be more clearly and publicly defined.


Assuntos
Medicamentos sob Prescrição , Estados Unidos , Humanos , Comitês Consultivos , United States Food and Drug Administration , Política , Rotulagem de Medicamentos
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