China
Africa
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Applications of RWE for Regulatory Uses
Published in Kelly H. Zou, Lobna A. Salem, Amrit Ray, Real-World Evidence in a Patient-Centric Digital Era, 2023
Eleanor E. Panico, Corinne S. Pillai, Ewa Filipowska, Kelly H. Zou
Regardless of the potential advantages of harnessing RWE for the purpose of further characterizing the safety of a product, there are some limitations. Such limitations primarily include bias introduced by the inconsistency in the nature of the data sourced and confounding i.e., variables that can influence the dependent and independent variables being measured thus skewing the results. Such limitations can be mitigated by properly-designed and well-discussed protocol and statistical analysis plan with the health authority of interest or other statistical or non-statistical strategies (Beaulieu-Jones et al., 2020). Furthermore, global health authorities have specific programs or pilot programs designed to help assess utility of RWE and other novel approaches to reach a common goal, like drug safety characterization. As expressed in this chapter, FDA and other regulators are willing to think creatively and collaborate with industry in the interest of public health to ensure the safety and effectiveness of drugs.
Litigation trends in the EU, EU Member States, and UK
Published in Andrea Parziale, The Law of Off-label Uses of Medicines, 2023
National pharmaceutical regulators are not the only institutions that can be liable for negligent pharmacovigilance. In fact, the pivot of the EU pharmacovigilance system is the European Commission, as advised by EMA. Formally, the regulatory authority in charge to make decisions about MAs of centrally authorised medicines is the EU Commission. This latter typically follows the scientific advice provided for by the scientific committees of EMA, in particular, the Committee for Medicinal Products for Human use (CHMP) and the Pharmacovigilance Risk Assessment Committee (PRAC). Although EMA has no formal regulatory power over centrally authorised medicines, its advisory function makes it a para-regulatory body.81 Therefore, by EU pharmaceutical regulators (or just EU regulators) we will mean both the commission and EMA.
Regulation and Performance Improvement 1
Published in Rui Nunes, Healthcare as a Universal Human Right, 2022
Pluralistic competition among providers, often found in traditional purchaser–provider splits and free-market systems, is not intrinsically inconsistent with the principles of equity, efficiency, and responsiveness (Khaleghian and Gupta 2005). However, market failure can lead to unacceptable consequences in healthcare that require effective regulation. Managed competition is itself a function of regulation, both in principle and in the traditional healthcare policy sense of a purchasing strategy that balances the competing demands of payers and users. However, independent agencies can go even further in the control of the system. Independent regulators can avoid potential negative consequences, such as unjust discrimination of patients who need access to medical services. For example, since the creation of the National Health Service (NHS) in Britain and elsewhere, unsurprisingly, direct government regulation through the direct intervention of public officials has played a major role in regulation. In vertical healthcare systems in which financing and provision are accomplished in a hierarchical manner, regulation is always integrated with the delivery of healthcare. Direct regulation is a fundamental component of integrated vertical systems (Baldwin et al. 2011).
The development of a stakeholder-endorsed national strategic plan for advancing pain education across Canadian physiotherapy programs
Published in Canadian Journal of Pain, 2022
Timothy H. Wideman, Geoffrey Bostick, Jordan Miller, Aliki Thomas, André Bussières, David Walton, Yannick Tousignant-Laflamme, Lisa Carlesso, Judith Hunter, Kadija Perreault, Barbara Shay
However, an important challenge that remains underaddressed within the pain education literature includes potential avenues for facilitating collaboration across the different stakeholders within health professions. Within each profession there are multiple and diverse stakeholders that are directly or indirectly involved and/or invested in pain education. For instance, clinical educators and students are directly involved in pain-related teaching and learning and may be influenced by important upstream and downstream stakeholders. In this context, people living with pain can be considered downstream stakeholders because they may receive treatment from newly trained clinicians but are not always positioned to influence how clinical students learn about pain. Immediately upstream to pain educators are program administrators who coordinate curricula and who are well positioned to influence the curricula and resources available for pain education. Further upstream are stakeholders that help govern the profession and regulate professional education. These include the regulators that set standards for entry-to-practice licensure and accreditation of health education programs as well as professional associations that advocate on behalf of the profession. Though each of these stakeholders is invested in pain education, there is very little research that addresses how these groups might approach the coordination required to achieve the type of population-level change that is called for within the national pain strategy.
Limitations on the Capability of the FDA to Advise
Published in The American Journal of Bioethics, 2022
Leah Z. Rand, Aaron S. Kesselheim
The FDA fulfills multiple roles as a regulator and communicator in its oversight of tobacco products, and these roles also affect its regulation of medical products. Flexibility in approvals, like Accelerated Approval, affect not just individual patients using the new medicine, but also future patients and the public’s health interest in safe and effective medicines. As tobacco regulation highlights, products used by individuals may have population-level effects. Reforming evidence requirements and approval pathways, particularly Accelerated Approval, at the FDA would promote its responsibilities as a producer of knowledge, so that it can provide better evidence and advice to patients, prescribers, and the public. The FDA should be proactive in communicating the individual and public health reasons for approvals, particularly for products like vaccines, and where there is a lack of evidence for newly approved drugs. As the experience regulating medicines shows, the FDA can effectively use its regulatory power to compel evidence production prior to approval, which supports its role as an advisor with guidance rather than information-provider only. Though different approval standards apply to medicines and tobacco products, the evidence development and communication of both share common features that can inform the FDA’s role in regulating each area.
How do safety warnings on medicines affect prescribing?
Published in Expert Opinion on Drug Safety, 2022
Barbara Mintzes, Ellen Reynolds, Priya Bahri, Lucy T Perry, Alice L Bhasale, Richard L Morrow, Colin R Dormuth
In part, inconsistencies between countries reflect underlying differences in legislated authority. A comparison of the EMA, FDA, HC and TGA found that both the EMA and FDA have more explicit legislative mandates for post-market risk communication than the TGA or HC [8]. The EMA’s PRAC, which includes national and independent experts and health professionals and patient representatives, evaluates post-market risks, and issues legally binding recommendations that guide risk communication across all treatment areas [8]. The EMA publishes its rationale for issuing advisories via PRAC reports; the FDA routinely provides a data summary supporting risk assessments in advisories; HC and the TGA do not always provide a detailed rationale for judgments. The TGA also differs from the other included regulators in not making DHPCs publicly available [15].