The hazards of rapid approval of new drugs

Martin, Jennifer; Shenfield, Gillian M.

doi:10.18773/austprescr.2016.005

Cited by 9 publications

(5 citation statements)

References 7 publications

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“…27 Several countries, such as the United States and Canada, have developed a Fast-Track process for drug approval, although not without controversy and increased safety warnings, compared to drugs approved through the usual regulatory process. 28 Yet, "cutting red tape" in Australia has been beneficial for bringing technologies and drugs to patients, 29 and some benefit of Fast-Tracking measures has been documented by the US FDA. 30 During the current pandemic, accelerated regulatory procedures for drug approvals have already been implemented, including the FDA's Emergency Use Authorization for remdesivir.…”

Section: Resultsmentioning

confidence: 99%

Caregivers' Willingness to Accept Expedited Vaccine Research During the COVID-19 Pandemic: A Cross-sectional Survey

Goldman

Marneni

Seiler

et al. 2020

Clinical Therapeutics

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Purpose To determine predictors associated with caregivers’ willingness to accept an accelerated regulatory process for Coronavirus disease 2019 (COVID-19) vaccine development. Methods An international cross-sectional survey of 2557 caregivers arriving with their children to 17 pediatric Emergency Departments (ED) across six countries from March 26 to June 30, 2020. Caregivers were asked to select one of four choices they agreed with the most regarding a proposed COVID-19 vaccine approval process, in addition to questions regarding demographics, the ED visit, and attitudes about COVID-19. Univariate analyses were conducted using the Mann-Whitney test for comparing non-normal continuous variables, independent t-test for comparing normally distributed continuous variables, and Chi-square or Fisher’s exact test for categorical variables. Variables of interest subsequently underwent a multivariable logistic regression analysis to determine independent factors associated with caregivers’ willingness to accept abridged COVID-19 vaccine development. A p-value less than 0.05 was considered significant. Findings Almost half (1101/2557; 43%) of caregivers reported that they are willing to accept less rigorous testing and post-research approval for a new COVID-19 vaccine. Independent factors associated with willingness to expedite COVID-19 vaccine research included children that were up-to-date on their vaccination schedule (Odds Ratio (OR) = 1.72, 95% Confidence Interval (CI) = 1.29-2.31), caregivers concerned that they had COVID-19 at the time of survey completion in the ED (OR = 1.1, 95% CI 1.05-1.16), and caregivers that intend to vaccinate their children against COVID-19 if a vaccine becomes available (OR = 1.84, 95% CI 1.54-2.21). Mothers completing the survey were less likely to approve changes in the vaccine development process (OR = 0.64, 95% CI = 0.53-0.78). Implications Less than half of caregivers in a global sample are willing to accept abbreviated vaccine testing during the COVID-19 pandemic. As part of an effort to increase acceptance and uptake of the new vaccine, especially in order to protect children, public health strategies and individual providers should understand caregivers’ attitudes towards approval of the vaccine and consult them appropriately.

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Section: Resultsmentioning

confidence: 99%

Caregivers' Willingness to Accept Expedited Vaccine Research During the COVID-19 Pandemic: A Cross-sectional Survey

Goldman

Marneni

Seiler

et al. 2020

Clinical Therapeutics

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show abstract

“…Even then, there are several examples of rapidly registered therapeutic goods where product removal was required once the “real world” phase 4 data became available. A recent article suggested that registration approval can be made too early for drugs with limited data or data reliant on biochemical surrogate markers, which can potentially translate into less chance of identifying adverse drug reactions before marketing 4 . We found evidence of at least 35 drugs removed — not including those with reduced indications or black box warnings —after United States Food and Drug Administration registration due to adverse drug events 5 .…”

mentioning

confidence: 75%

Medicinal cannabis in Australia: the missing links

Martin

Bonomo

2016

Medical Journal of Australia

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“…Similar pathways currently operate in Europe, Canada and the USA. 14 In response to the review, the TGA released two consultation papers in 2017. The first aimed to seek opinions on enhancements to the current Medicines Vigilance Framework in order to better identify and address medicine safety concerns.…”

Section: Pharmacovigilance and Expedited Approvalsmentioning

confidence: 99%