Patient-centered pharmacovigilance: priority actions from the inherited bleeding disorders community.

"The authors declared the following potential conflict of interest with respect to the research, authorship, and/or publication of this article: HFA and the NHF, co-leaders of the 2020 Product Safety Summit, sought participation in and support of the Safety Summit from all manufacturers of bleeding disorders medications. HFA and NHF contributed equally to the development and deployment of the Safety Summit and subsequent work and materials; all funding supporting was split equally between the two nonprofit organizations. S.W. is employed by HFA as VP for Public Affairs. S.M. is employed by HFA as President & CEO. HFA receives honoraria for their participation on patient advocacy advisory boards for Takeda, BioMarin, and Sanofi. M.G. is employed by HFA as a director of policy. HFA is a national nonprofit organization that assists, educates, and advocates for the bleeding disorders community. HFA receives funding in the form of donations from individuals, philanthropic foundations, drug/biotech manufacturers, and specialty pharmacies; a cooperative grant from the US Centers for Disease Control; an engagement award from the Patient-Centered Outcomes Research Institute; sponsorship income from a symposium it holds annually. A list of corporate supporters can be found at https://www.hemophiliafed.org/home/our-role-and-programs/what-is-hfa/our-supporters/. F.R. is a consultant and was paid by NHF/HFA to contribute her expertise to this article. She has received consulting fees from F. Hoffmann-La Roche Ltd for speaking at a symposium, and for work with the World Federation of Hemophilia, American Thrombosis and Hemostasis Network, and European Haemophilia Consortium. The opinions expressed in this article by N.S. and L.A.V. are their own and not necessarily reflective of those of the NHF or its Board of Directors. The other authors have no conflicts of interest relevant to this article."

"Funding: The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The entire Safety Summit initiative and this manuscript were funded by NHF and HFA, with support from LFB Pharmaceuticals, HEMA Biologics, Pfizer, Bayer, Octapharma, CSL Behring, Genentech, Spark Therapeutics, BioMarin, Novo Nordisk, Sanofi, Kedrion, Grifols, Takeda, BPL, and Roche. Additional support from Takeda and Genentech was provided to support the preparation of this manuscript. F.R. provided professional consulting services to NHF/HFA for this article."