Why Is FDA Clearance So Difficult?

The U.S. Food and Drug Administration (FDA) is empowered to review every new food, cosmetic, radioactive and pharmaceutical product for its safety and effectiveness. The review process is rigorous and often takes years. Many corporations and private citizens wonder why the FDA is so strict.

Process

• The FDA's clearance process for pharmaceutical drugs is the most time consuming. According to Drugs.com, "once a company develops a drug, it undergoes around three and a half years of laboratory testing before an application is made to the [FDA] to begin testing the drug in humans. Only one in 1,000 of the compounds that enter laboratory testing will ever make it to human testing." The human testing phase lasts six years, and the FDA's final review process usually takes two to three years. A successful drug will take over a decade to complete FDA clearance.

Safety

• The FDA justifies its high standards by appealing to its mission: "protecting the public health by assuring the safety, effectiveness and security of human and veterinary drugs, vaccines and other biological products, medical devices, our nation's food supply, cosmetics, dietary supplements and products that give off radiation." In order to abide by this mandate, the FDA claims the lengthy review process is necessary. Only such a rigorous process can ensure that companies do not sell injurious products to consumers.

Limited Resources

• The FDA is also limited by its resources. With such a broad mandate, the FDA is always investigating a wide range of products. Although there are almost 12,000 staff members working for the FDA, this is not enough to ensure a quick review of each product.