Plague described a confluence of interests whose purpose in business is to undermine health. It pointed to an axis of evil and the acronyms of regulators (the FDA, the FTC, the USP and the DEA) as the causative agents.. The food and pharmaceutical industries are major contributors to their budgets.
The Food and Drug Administration (FDA) is responsible for regulating food, dietary supplements, drugs, cosmetics, medical devices, blood products and vaccines in the United States. It derives its power from the Federal Food, Drug, and Cosmetic Act passed in 1938, amended in 1997, updated for bioterrorism after 9-11 and modified to include new user fees in 2003.
The FDA is supposed to ensure that only safe and effective drugs are approved. They are also required to monitor these drugs for continued safety once they are approved.
As a part of the Department of Health and Human Services, the FDA’s mission is to promote and protect the public’s health.
In 1992, Congress passed the Prescription Drug User Fee Act. They created the user fee program to help solve the FDA’s chronic resource shortages.
This law gave the FDA the authority to collect user fees from pharmaceutical manufacturers seeking drug approval. The law provides that any company that wants to submit a new drug to the FDA for approval, must pay a fee to support the review process. In addition, companies pay annual fees for each of their already approved prescription drugs on the market.