Secret safety warnings on medicines: A case study of information access requests

Abstract

Purpose There has been less attention to the transparency of postmarket evidence of harmful effects of medicines than of premarket clinical trial data. This is a case study of requests for Australian “direct health professional communications” (DHPCs). These letters are used by regulators and manufacturers to inform clinicians of emergent evidence of harm. DHPCs are not made public by Australia's Therapeutic Goods Administration (TGA). Methods We requested all DHPCs sent out in Australia from 2007 to 2016 inclusive for 207 drugs that were subject to safety advisories over this decade in Canada, the United Kingdom, and/or the United States. We contacted 39 manufacturers (February to May 2018), with repeat requests to nonrespondents, and a follow‐up freedom‐of‐information (FOI) request to the TGA. Results Fifteen companies provided information, either sending DHPCs (n = 4, on five drugs) or affirming none were sent out (n = 11). The remaining 24 of 39 (62%) companies did not provide DHPCs: nine (23%) refused the request, often citing commercial confidentiality; the rest provided no answer despite repeat requests. In total, we had no information for 170 of 207 (82%) of the drugs. Our FOI request to the TGA was unsuccessful. Conclusions Our experience highlights unacceptable secrecy concerning safety warnings previously sent to thousands of Australian clinicians. In the absence of explicit regulatory policy supporting disclosure, companies differed in their response. These letters warn of serious and often life‐threatening harm and guide safer care; full ongoing public access is needed, ideally in searchable online databases.

A descriptive analysis of medicines safety advisories issued by national medicines regulators in Australia, Canada, the United Kingdom and the United States ‐ 2007 to 2016

“…For example, the FDA changed its approach to risk communication during the study period, consolidating multiple communications into a single Drug Safety Communication and using REMS as a tool to manage post‐approval medicine risks. In addition, unlike the other included jurisdictions, in Australia, DHPCs have never been made publicly available 18 …”

“…Solid circles represent the advisories about NOACs and hemorrhage risk, open circles represent the advisories about hemorrhage associate with dabigatran drug interactions [Colour figure can be viewed at wileyonlinelibrary.com]approval medicine risks. In addition, unlike the other included jurisdictions, in Australia, DHPCs have never been made publicly available 18.…”

Regulatory post‐market drug safety advisories on cardiac harm: A comparison of four national regulatory agencies

“…For Canada, the US, and the UK, we were able to access DHPCs from the regulators. In Australia, however, DHPCs are not made publicly available and our team was unable to obtain a comprehensive set via requests to companies or a freedom of information request to the TGA 25 . Therefore, DHPCs from Australia have not been included in this study.…”

Postmarket Safety Communication for Protection of Public Health: A Comparison of Regulatory Policy in Australia, Canada, the European Union, and the United States

“…73 There is no formal requirement in Australian regulation or guidance for the TGA to oversee postmarket safety communications by industry, but discussions about DHPCs occur informally. 74 The TGA does not publish DHPCs issued by industry or provide them to parties requesting them. 74 The TGA formally adopts many EMA guidelines (for example for risk management plans), and these may be adopted unchanged or with modifications.…”

“…74 The TGA does not publish DHPCs issued by industry or provide them to parties requesting them. 74 The TGA formally adopts many EMA guidelines (for example for risk management plans), and these may be adopted unchanged or with modifications. Public consultation occurs prior to adoption.…”