University of Miami Business Law Review


Nicole C. Perez

Document Type



The pharmaceutical industry is one of the largest, and most lucrative, industries in the world, worth about one trillion U.S. dollars. Specifically, the United States accounts for more than one-third of the global pharmaceutical market with about 340 million dollars in sales. Not only is the pharmaceutical industry one of the biggest industries profit-wise, but it is also an industry that affects almost every single person in the world. In a nation where healthcare issues are always on the rise, ensuring that American citizens benefit from pharmacology is essential to improving the nation’s healthcare system. The Food and Drug Administration (FDA) is responsible for protecting the public’s health by assuring its consumers that the pharmaceutical drugs approved in the United States are both safe and effective. However, with great responsibility, great problems are sure to follow.

The FDA’s approval process for pharmaceutical drugs is highly stringent, costly, and lengthy. While it makes sense to have a stringent approval process for pharmaceutical drugs, the cost and duration of the process outweigh the benefits that the FDA is trying to achieve. The FDA’s stringent approval process refuses to allow U.S. consumers access to potentially life-saving medicines that have already been approved in other countries, such as Great Britain, whose pharmaceutical regulatory system is most similar to that of the United States than any other country. By enacting an international reciprocity agreement that allows the U.S. to automatically approve drugs that have been approved in similar countries, the cost and duration of the FDA’s drug approval process would substantially decrease, which could potentially save millions of lives.