Worldwide Regulatory Agencies

Worldwide Regulatory Agencies

HCA 375

Heidi Marshall

Prof Kendra West

08/17/2009

In a day and age where pharmaceutical companies are developing drugs at an astonishing pace, it is important patient safety is a number one priority. Pharmaceutical companies are working hard to provide consumers with the safest and most effective products possible, but who decides what is considered safe? The US is fortunate to have an agency that monitors, regulates, and enforces laws to protect consumers from possible sub-standard products. This paper will discuss the arm of the government that regulates the pharmaceutical companies for consumers, the laws that are enforced by this agency, how CRO’s comply with these regulations and guidelines, and finally what is being done about the regulation process from a global stand point.

The US Food and Drug Administration, also known as the FDA, is the branch of the US Department of Health and Human services that is responsible for “protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation” [ (US Department of Health and Human Services, 2009) ]. The FDA laws, regulations, and guidelines provide a roadmap of expectations from a customer who has complete authority over the approval process [ (McLaughlin & Kaluzny, 2006) ]. The office within the FDA that specifically deals with over-the-counter and prescription drugs is the Center for Drug Evaluation and Research or CDER [ (US Department of Health and Human Services, 2009) ]. Americans benefit from having the safest and most advanced pharmaceutical system in the world and the main watch dog for the pharmaceutical system is the CDER [ (US Department of Health and Human Services, 2009) ].

Part of the FDA’s job is not only to monitor pharmaceutical companies but to enforce the laws that are in...