Abstract
In the wake of the withdrawal of the nonsteroidal anti-inflammatory drug rofecoxib, regulators worldwide reconsidered their approach to postmarket safety. Many have since adopted a “life cycle” approach to regulation of medicines, facilitating faster approval of new medicines while planning for potential postmarket safety issues. A crucial aspect of postmarket safety is the effective and timely communication of emerging risk information using postmarket safety advisories, commonly issued as letters to healthcare professionals, drug safety bulletins, media alerts, and website announcements. Yet regulators differ in their use of postmarket safety advisories. We examined the capacity of regulators in the United States, Europe, Canada, and Australia to warn about postmarket safety issues through safety advisories by assessing their governance, legislative authority, risk communication capabilities, and transparency.
| Original language | English |
|---|---|
| Pages (from-to) | 1424-1442 |
| Journal | Clinical Pharmacology and Therapeutics |
| Volume | 109 |
| Issue number | 6 |
| Early online date | 1 Jan 2020 |
| DOIs | |
| Publication status | Published - Jun 2021 |
Funding
This study was partially supported by funding provided by the Australian Government National Health and Medical Research Council (grant ID #1122332) with cofinancing by the Canadian Institutes of Health Research (grant ID #153275). A.L.B. received funding from a University of Sydney PhD Scholarship and a Harvard University Mobility Grant. A.S.'s work is funded by Arnold Ventures and the Harvard‐MIT Center for Regulatory Science. A.S. serves as the principal investigator on a grant from the US Food and Drug Administration on Risk Evaluation and Mitigation Strategy (REMS) Programs to Promote Appropriate Medication Use and Knowledge (75F40120C00044). M.L.D.B. is appointed as professor in Regulatory Science, for which the Chair is funded by the University of Copenhagen. In addition, she is director of the Copenhagen Center for Regulatory Science (CORS), based at the same university. CORS is a cross‐faculty university anchored institution involving various public (Danish Medicines Agency, Copenhagen University) and private stakeholders (Novo Nordisk, Lundbeck, Ferring pharmaceuticals, and LEO pharma) as well as patient organizations (Rare Diseases Denmark). The center is purely devoted to the scientific aspects of the regulatory field and with a patient‐oriented focus and its research is not company‐specific product or directly company related. Apart from the position at the University of Copenhagen, M.L.D.B. is employed part‐time by Utrecht University as a senior researcher conducting research under the umbrella of the Utrecht‐WHO Collaborating Center for Pharmaceutical Policy and Regulation. This center receives no direct funding or donations from private parties, including pharmaceutical industry. Research funding from public‐private partnerships, e.g., IMI, The Escher Project ( http://escher.lygature.org/ ) is accepted under the condition that no company‐specific product or company related study is conducted. The Center has received unrestricted research funding from public sources, e.g., World Health Organization (WHO), Netherlands Organization for Health Research and Development (ZonMW), the Dutch National Health Care Institute (ZIN), EC Horizon 2020, the Dutch Medicines Evaluation Board (MEB), and the Dutch Ministry of Health. In 2017–2020, J.L. received payment for being on a panel at the American Diabetes Association, for talks at the Toronto Reference Library, for writing a brief in an action for side effects of a drug for Michael F. Smith, lawyer and a second brief on the role of promotion in generating prescriptions for Goodmans LLP and from the Canadian Institutes of Health Research for presenting at a workshop on conflict‐of‐interest in clinical practice guidelines. He is currently a member of research groups that are receiving money from the Canadian Institutes of Health Research and the Australian National Health and Medical Research Council. He is member of the Foundation Board of Health Action International and the Board of Canadian Doctors for Medicare. He receives royalties from University of Toronto Press and James Lorimer & Co. Ltd. for books he has written. B.J.M. is a member of Health Action International (HAI‐Europe Association), a nonprofit organization that supports public interests in pharmaceutical policy. She was a member of Health Canada's Expert Advisory Group on the Marketing of Opioids in 2018 and 2019, and acted as an expert witness for Health Canada in 2020 in a legal case related to marketing of an unregistered product. She has no other interests to declare and receives no funding from pharmaceutical companies. All other authors declared no competing interests for this work.
