This week the PharmaTell team has been catching up with the latest headlines on some Intel we covered previously. Check out the updates on the US Baby Formula Shortage & new moves in the Zantac litigation.
US Infant Formula Shortage
In the spring we wrote about the Infant Formula Shortage in the US and some of the events that led up to the crisis – see this post US Baby Food Shortage.
Last week the FDA issued a Press Release and report of the FDA Evaluation of the Infant Formula Response. In the press release Dr. Califf, Commissioner of Food & Drugs at the FDA notes that they have been working with other government agencies such as USDA and USHHS to expand access to infant formulas and ensure the products meet nutritional, safety, and quality standards. As part of their efforts, they are working on expanding manufacturing, diversifying suppliers, and allowing new entrants into the US marketplace. We are glad to see these as some of the outcomes of the investigation and that the agency is once again focusing on identifying potential shortages, and enhancing review of manufacturing and operations associated with nutritional products.
The evaluation report was written by Dr Steven Solomon – a veteran of the FDA’s Office of Regulatory Affairs. He highlighted five areas of improvement for the agency – among the 15 key findings & recommendations from the investigation.
The need for modern information technology that allows for the access and exchange of data in real time to all the people involved in response.
Sufficient staffing, training, equipment, and regulatory authorities to fulfill the FDA’s mission.
Updated emergency response systems that are capable of handling multiple public health emergencies occurring simultaneously.
Increased scientific understanding about Cronobacter, its prevalence and natural habitat, and how this translates into appropriate control measures and oversight.
Assessment of the infant formula industry, its preventive controls, food safety culture and preparedness to respond to events.
Dr. Califf reiterated that the agency is committed to addressing the issues uncovered – and will be providing updates as they work through the findings, as mentioned in the conclusions of the document:
Throughout the fall, the FDA will form working groups charged with implementing the recommendations. While the scope of this evaluation is limited to infant formula, some of the findings highlight systemic challenges that may require enterprise-level changes.
Another Dimension to the Zantac Litigation
The first trial against the major pharma firms associated with the Zantac litigation was dropped – apparently after the plaintiff settled with generics manufacturers [see our post Heartburn from Zantac]. The remaining federal class action suits are scheduled to begin in October.
A recent article from FiercePharma states that the Zantac manufacturers are now facing litigation at the state level. The suits are from plaintiffs suffering from cancers not covered in the federal action.
The Federal litigation addresses 5 specific cancer types: bladder, esophageal, gastrointestinal, liver, and pancreatic. This list is a subset of a larger set of cancers originally compiled for the litigation. The list was narrowed for the Federal trials, but now claimants with the omitted cancer types – breast, kidney, colorectal, prostate, and lung – are filing cases in the state courts. This adds another level of risk & complexity to the Zantac saga. We’ll keep our eyes out for updates as the cases move through the court systems.
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