FDA Inspectors Say Valisure’s Former Pharmacy Division Failed to Meet Drug Security Requirements
Inspectors say Valisure appeared to be unfamiliar with key portions of the Food, Drug and Cosmetic Act linked to drug supply chain security.
Inspectors say Valisure appeared to be unfamiliar with key portions of the Food, Drug and Cosmetic Act linked to drug supply chain security.
Plaintiffs plan to appeal the decision, maintaining that there is more than sufficient evidence about the link between Zantac and cancer to allow juries to consider lawsuits
Valisure has regularly found cancer-causing chemicals in drugs and consumer products before the FDA in recent years.
The EU and Canada have set daily acceptable limits for all nitrosamines, but the FDA has not. During a meeting this week the U.S. regulators met to discuss how to bets address the problem with nitrosames in drugs.
Research published last month highlight the link between various cancers and Zantac, including liver, lung, gastric and pancreatic cancers.
Zantac cancers supported in the federal courts are limited to bladder, esophageal, gastric, liver and pancreatic. Thousands of other lawsuits are being filed in state courts involving breast, kidney, colorectal, prostate, and other cancers.
Zantac Daubert hearings will be held by the judge to determine whether proposed expert witness testimony about the risk of specific cancers from Zantac is sufficiently sound to present to a jury.
Shortly before trial was set to begin in Illinois state court, a Zantac cancer settlement was reached with generic drug makers, and the plaintiff dismissed their lawsuit against name-brand manufacturers
Approaching trial dates and analyst estimates that Zantac settlement payouts may reach $45 billion caused investor stock selloff this week
The cancer-causing contaminant, a nitrosamine, was detected at levels exceeding the daily acceptable allowance set by the FDA, but there will be no recall due to fears of a shortage.