Month: September 2022

US FOOD AND DRUGS ARE TREATED DIFFERENTLY. The FDA nominally has jurisdiction over food and drugs. The regulation of meat products is led by USDA, with FDA giving guidance, and food additives by the FDA, who also has exclusive preview over drugs. The Precautionary Principle is rigorously applied to drugs. In food additives, the approach is risk management, when applied at all. View in LinkedIn

SPLIT POLICY AGENCY. The FDA employs completely divergent philosophies for the regulation of pharmaceuticals versus food additives. This contrasts with the USDA regulation of meat, which is both permissive, light-handed, and based entirely risk assessment, not need. The WTO is also based on similar permissive risk-assessment principles. View in LinkedIn

QUALITY BY DESIGN (QbD) by the FDA: "The focus of this concept is that quality should be built into a product with an understanding of the product and process by which it is developed and manufactured along with a knowledge of the risks involved in manufacturing the product and how best to mitigate those risks." http://en.m.wikipedia.org/wiki/Quality_by_Design View in LinkedIn

QbD FOR DRUG MANUFACTURING AT FDA. "In FDA’s Office of New Drug Quality Assessment (ONDQA), a new risk-based pharmaceutical quality assessment system (PQAS) was established based on the application of product and process understanding." http://en.m.wikipedia.org/wiki/Quality_by_Design View in LinkedIn

GREAT SPOKESPERSON. "Peter Montague is director of the Environmental Research Foundation ... longtime editor of Rachel’s Environment and Health News ... He has co-authored two books on toxic heavy metals in the natural environment and is presently writing a book about the precautionary principle." http://www.multinationalmonitor.org/mm2009/032009/interview-montague.html View in LinkedIn

PETER MONTAGUE will be extensively quoted in the next sections because of his clear-sighted analysis of the issues at stake, and the consequences, when we are guided by the Precautionary Principle versus Risk-Benefit analysis in regulation of potentially harmful products. View in LinkedIn

THE ROOT CAUSE of the enormous divide between the U.S.and EC food safety regulators and which us behind the enormous gulf in TTIP food harmonization talks: the Precautionary Principle which charges governments to safeguard the people and Cost-Benefit or risk based analysis that assumes that economic good trumps all other goods. View in LinkedIn

COST-BENEFIT ANALYSIS ASKS, "Is this harm justified by related benefits?" If the answer is yes, or even if the answer is unknown, the harm is allowed to continue. The precautionary principal asks, "Is this harm avoidable?" http://www.multinationalmonitor.org/mm2009/032009/interview-montague.html View in LinkedIn

"COST-BENEFIT ANALYSIS enjoys a special status in U.S. law and policy. With few exceptions, statutory law, common law and government regulations all presume that economic growth provides net benefits (more benefits than costs) to society until an explicit cost-benefit analysis can show otherwise." http://www.multinationalmonitor.org/mm2009/032009/interview-montague.html View in LinkedIn

RED BLOODED CAPITALISM is the root of the US cost-benefit approach to managing risk; that economic good trumps all others (within reason), and is a proud US value that joins rugged individualism and less government oversight of private capital. Given its due it has made the USA a world power in a very short period of time. View in LinkedIn