Ottawa passes drug safety law

Quebec passes right-to-die law.

Health Canada "passes the buck" on diabetes drug, researcher charges.

Traffic law enforcement and safety.

The inverse benefit law: how drug marketing undermines patient safety and public health.

Recent highly publicized withdrawals of drugs from the market because of safety concerns raise the question of whether these events are random failures or part of a recurring pattern. The inverse benefit law, inspired by Hart's inverse care law, states that the ratio of benefits to harms among patients taking new drugs tends to vary inversely with how extensively the drugs are marketed. The law...

Drug Safety Unscrambling Post - Approval Drug Safety Monitoring

Among the thorny issues confronting newlyconfirmed FDA Commissioner Gottlieb is the unresolved rulemaking proposal to permit generic drug manufacturers to amend safety warnings in their labels without prior FDA approval. At present, only pioneer branded manufacturers holding New Drug Applications may make such amendments to respond to newlydiscovered evidence of a reasonable association between...