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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

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

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

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

THE FDA "is the oldest comprehensive consumer protection agency in the U. S. federal government. The FDA and its responsibilities have undergone a metamorphosis since 1906. Yet the core public health mission of the agency remains now as it did then." The EU food agencies adopt the same mantra of consumer protection. http://lnkd.in/dZ7RaBU View in LinkedIn

DRUG PRECAUTIONARY PRINCIPLE is alive and well at the FDA and other drug regulatory agencies worldwide. The proponent of a new product undertakes the cost and responsibility of proving, to an objective statistical criterion, that the drug is both safe and effective. Obviously, safety is tempered by cost-benefit analysis, but efficacy (read "need" here) is held to the highest standards. View in LinkedIn

PRECAUTIONARY PRINCIPLE USED IN DRUG APPROVALS. "When a drug company wants to market a new drug, we ask them to provide reasonable evidence of no harm and we ask them to show that their new product will do some good (they must show "efficacy"). The assumption is that a new drug will be harmful or useless (or both) and it's up to the company to prove otherwise." http://www.multinationalmonitor.org/mm2009/032009/interview-montague.html View in LinkedIn

BILGE PURGING BAN IS RECKLESS PARALYSIS. "An early environmental application of the precautionary principle involved the prohibition of the purging of ship bilge contents and other wastes into the oceans. This requirement was justified by the paucity of data on the effects of the purged substances. Hence, a scientific risk assessment on this practice was not possible." http://www.agbioforum.org/v3n4/v3n4a13-hathcock.htm View in LinkedIn

EXCESSIVE PRECAUTION. "Excellent examples include the outbreak of cholera resulting from fear of chlorinated water." ( I.e., "unjustified fear"). http://www.agbioforum.org/v3n4/v3n4a13-hathcock.htm View in LinkedIn

ACTUAL QUOTE. "Upon initial consideration, it might seem that the only alternative to precaution is recklessness but, in fact, excessive precaution leads to paralysis of actions resulting from unjustified fear. In many cases, the slight but non-zero risk associated with a product or process is far safer than the alternative of doing nothing." http://www.agbioforum.org/v3n4/v3n4a13-hathcock.htm View in LinkedIn