March 2016

Global Pharma Primer

28. march 2016 at 8:00 | Veronika Valdova, ARETE-ZOE |  Risk Management

The material included in these modules serves many interests by facilitating understanding of construct, dynamics, and influences affecting regulatory policies and corporate decision-making that ultimately determine access, availability, and effectiveness of pharmaceutical products. In the following modules we will introduce and describe the highly specialized and often disconnected components of pharmaceutical research, drug development/manufacturing, marketing, regulatory policies and practices, and use case studies to qualify the relative effectiveness of safeguards to prevent harm. Additionally, how have pressures to reduce health care costs or increase safety actually affected both aspects of public concern within a global context because transnational interests influence national circumstances.

FDA Draft Guidance on Stem Cells

21. march 2016 at 8:00 | Veronika Valdova, ARETE-ZOE |  Medicine & Pharmacy

Due to considerable interest in the Public Hearing, "Request for Comments - Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products," the FDA intends to extend the comment period and has postponed the hearing. The agency also intends to schedule a scientific workshop to gather information from stakeholders regarding the generation of scientific evidence to facilitate the development of safe and effective cell based therapeutics.

Operation Concord

7. march 2016 at 17:12 | Veronika Valdova, ARETE-ZOE |  Risk Management

In March 2015, New Zealand police announced in a public conference that suspected environmental activists are threatening to contaminate infant formula in a backlash against pesticide use. The threat had been under investigation since November 2014 under code name Operation Concord. In March 2015 the police appealed for public assistance to track down the blackmailer.

Anonymous letters were sent to dairy producers Fonterra and Federated Farmers, threatening to poison infant formula and other products if New Zealand did not cease to use the poison by the end of March. The threat was only made public in March 2015 but manufacturers, suppliers and distributors were advised to strengthen their supply chain already in November 2014.

More than 2600 people were considered in relation to the threats and 60 persons of interest were approached for interviews.

In October 2015, a businessman from Auckland was arrested and charged with criminal blackmail. His name was suppressed for 6 months for unrelated reasons and he was not named by the media.

In February 2016, the blackmailer was finally identified as Jeremy H. Kerr. The businessman sells alternative rat poison - cyanide-based Feratox. Among other customers he supplies his poison to the New Zealand government.

The motivation was to increase market share in pest control by replacing 1080 with his own product Feratox.

No consumer goods were ever laced with 1080 and no one was poisoned. However, the reputation of the dairy industry in New Zealand was severely affected by the affair as the result of consumer panic. Many producers and distributors of nutraceuticals were affected by the affair, and had to adopt numerous measures to secure their supply chain.