Proposed regulations mandated by the Sanitary Food Transportation Act and the Food Safety Modernization Act hold powerful implications for the future of the cold chain industry. The business environment is shifting, and the proposed rule is just one piece of this changing landscape, as the industry experiences an overall increase in regulations, customer-required audits and augmented public pressure from food recalls.
The times they are a changin' for the players across pharmaceutical supply chains, from API suppliers to CMOs, to manufacturers, packagers, distributors, dispensers/pharmacies ... just about everyone across the chain.
In 2011, batches of a cancer medication called Avastin, on their way to U.S. doctors from Canada, were found to contain no active ingredients. They were counterfeit - a rarity on U.S. soil. While no patient ever received the drugs, the fact that a potentially life-threatening counterfeit was able to make it to the U.S. shocked the pharmaceutical industry. It pointed to a growing trend - triggered by the rise of e-commerce and globalization - reaching the United States.
Of all the issues the Obama administration is grappling with, a modest redesign of what food labels say about sweeteners might not have seemed among the more controversial. But ever since First Lady Michelle Obama unveiled the plan last year, a lobbying frenzy has ensued.
The furious pace of M&A activity in life sciences indicates there is serious money to be made there. But successful companies must quickly adapt their supply chains to the challenges that shifting customer needs and industry regulations bring. Five crucial ideas that winners must understand are outlined below.
Analyst Insight: The industry finds itself in the eye of a perfect storm. Profits are falling from the patent cliff, pressuring companies to adopt new supply chain value propositions. Regulatory compliance and the Affordable Healthcare Act create process and cost pressure. The cold chain manages the Cs: challenges from complexity, connectivity, compliance and continuum of care. And, above all is the shift from fee-based services to outcome-based care and payment. - Rich Sherman, Principal Essentialist, Trissential
The Food and Drug Administration proposed rules on Friday that would govern the production of pet food and farm animal feed for the first time.
The regulation would help prevent food-borne illness in both animals and people, officials at the agency said, as people can become sick from handling contaminated animal food and from touching pets that have eaten it.