How Do Other Drug Regulators Compare to the FDA?

The United States Food and Drug Administration (FDA) is a regulatory body vetted by the US Federal Government. It is responsible for securing the safety of its citizens and livestock in the realm of consumables like food, medicines, chemicals and all of their biological delivery methods. The FDA charter, by default, makes it intimately tied to various industrial and economic entities within the United States.

Since the United States is the principal world leader in economics, the FDA is often viewed as the most efficient, thorough, and authoritative food and drug organization in the world. While the US FDA oversees the majority of food and medical innovation internationally, it is not the only world class regulatory department actively engaged in the safety of the world’s population. Comparable government committees throughout the industrialized world have matching, if not higher, standards than the US FDA. Without the “red tape” associated with overseeing an astronomically-huge country, many other regulatory bodies enjoy similar safety records, but have more streamlined processes.

A functional, if not scientific, method of surveying a food and drug regulatory body is a tri-fold comparison of the amount of time it requires to approve a product for consumption, the volume of new products, and the number of approved products that are recalled because of complications.

The four-phase approval process of the US FDA results in an average of 12 years from inception to approval. Statistically, only 1 in 5000 new products make it to market. In 2014, there were nearly 40 FDA-approved products and devices recalled. 40 recalls represent thousands of affected lives, and billions of invested dollars. Does the US FDA have a corner on efficiency and efficacy?

The food and drug regulatory bodies of the world are divided into six categories according to location. Here are the ratios of approval time, volume and recalls for each region.

AFRO: Africa

– completely import dependent region
– 50/50 introduction to success rate of approved new drugs and devices
– nearly all approvals have market and human success

AMRO: The Americas

– outlined above

EMRO: The Eastern Mediterranean

– 80-90% approval rate
– few recalls because of youth complications

EURO: Europe

– 9% marked decrease in food and drug reports and notifications by hazard in 2013, meaning an extremely efficient rate of product approval

SEARO: South And East Asia

– food and drug approvals according to need, population and mortality issues largely controlled by local Health Services Departments (HSD)

WPRO: The Western Pacific

– dependency upon western food and drug regulatory bodies
– nearly all resources devoted to HIV and malnutrition issues

A complete survey of all major food and drug regulatory bodies in the world separated by region can be viewed here. Many of these national agencies are established to oversee the importation of products, foods and medicines that are approved by larger authorities like the US FDA.

The purpose of a food and drug regulatory body is to provide oversight of the many products innovated by companies and individuals before they are introduced to the public. The matter of safety and efficiency is not necessarily commensurate with the size, richness and influence of a particular body. The US FDA is responsible for approving many innovations that the world’s population can benefit from. It is however, mired in certain processes which make it less-than-ideal. There are many methods and protocols from each regional food and drug regulatory body, that the US FDA could learn from. Humans need the best food and medicine innovations without the interference of ridiculous governmental blockades. After all, lives are at stake!


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