Monthly Round-Up of What to Read on Pharma Law and Policy
Topics range from issues related to FDA’s approval of aducanumab, to an analysis of the communication of survival data in cancer drug labels.
FDA
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Read more: To Address the Overdose Epidemic, Tackle Pharma Industry Influence To Address the Overdose Epidemic, Tackle Pharma Industry Influence
To combat the opioid epidemic, we have to understand how regulators failed to protect the public health as the market for prescription opioids grew.
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Read more: COVID-19 and the New Reproductive Justice Movement COVID-19 and the New Reproductive Justice Movement
The pandemic finally shifted the reproductive justice movement’s focus to abortion access, rather than abortion rights.
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Read more: Appeals Court Overturns FDA’s Partial Ban on Shock Devices: Analysis of Ruling Appeals Court Overturns FDA’s Partial Ban on Shock Devices: Analysis of Ruling
The court held that prohibiting electrical stimulation in some settings, but not others, runs afoul of a “practice of medicine” statutory provision.
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Read more: Why Do Differences in Clinical Trial Design Make It Hard to Compare COVID-19 Vaccines? Why Do Differences in Clinical Trial Design Make It Hard to Compare COVID-19 Vaccines?
Because of differences in how they were tested in clinical trials, it is difficult to make apples-to-apples comparisons for COVID-19 vaccines.
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Read more: A Proposal for Localized Review to Safeguard Genetic Database Privacy A Proposal for Localized Review to Safeguard Genetic Database Privacy
We must take action to make genetic data sharing more secure and increase the public’s perception of its importance and safety.
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Read more: “Stick to the Science”? FDA, Ethics, and Pandemics “Stick to the Science”? FDA, Ethics, and Pandemics
This post reflects on the ethical implications of FDA’s use of its emergency powers, and suggests opportunities for greater accountability moving forward.
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Read more: FDA Approves Aducanumab for Alzheimer’s Disease: An Unethical Decision? FDA Approves Aducanumab for Alzheimer’s Disease: An Unethical Decision?
FDA’s approval of aducanumab may run against the bioethical principles of beneficence and non-maleficence.
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Read more: What’s the Difference Between Vaccine Approval (BLA) and Authorization (EUA)? What’s the Difference Between Vaccine Approval (BLA) and Authorization (EUA)?
A Biologics License Application, or BLA, is FDA’s standard “full approval” mechanism for biological products, including therapeutics and vaccines.
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Read more: Aducanumab: A Bitter Pill to Swallow Aducanumab: A Bitter Pill to Swallow
Patients are understandably desperate, but their needs are best served by following the science, rather than lowering the standards for drugs.