You may have remembered some of these concepts during your law course in pharmacy school, but it’s important to remember our country’s regulation policy as much of our industry is highly regulated!
In the United States, all food, drugs, cosmetics, and medical devices, for both humans and animals, are regulated under the authority of the Food and Drug Administration (FDA). The FDA and its laws were created by government bodies in response to promoting and protecting the safety of the public when it comes to food, medicines, and medical devices. We highly recommend participating in a FDA rotation despite being highly competitive and costly for a budget-minded student, it is well worth the experience! Our pharmacists that have had this opportunity speak very highly of the rotation.
This introduction to federal pharmacy law discusses the FDA’s regulatory oversight and that of other agencies, the drug approval and development process, the mechanisms used to regulate manufacturing and marketing, as well as various violation and enforcement actions taken by the FDA to ensure pharmaceutical and corporate industry companies are maintaining compliance.
The main responsibility for the regulation of pharmaceuticals and the pharmaceutical industry is the Food and Drug Administration (FDA), with headquarters located in Silver Springs, MD.
The FDA formed in 1931 and is one of several branches within the US Department of Health and Human Services (HHS). The “sister” agencies to the FDA that also work in HHS are the Centers for Disease Control and Prevention (CDC), National Institute of Health (NIH), and the Healthcare Financing Administration (HCFA). These sites could be competitive to get rotations at during pharmacy school, but a lot of information can be found on their websites. Other agencies that fall under HHS also include the Agency for Healthcare Research and Quality (AHRQ), Centers for Medicare and Medicaid Services (CMS), Substance Abuse and Mental Health Services Administration (SAMHSA), and the Indian Health Service (IHS). Our main focus will be the FDA as they are the agency that solely regulates the drug industry.
The FDA is organized into a number of offices and centers headed by a commissioner. It is a scientifically based law enforcement agency whose mission is to protect the public health and ensure fairness between health-regulated industries (i.e., pharmaceutical, device, biological, and the consumer). The vast number of tasks done at the FDA is more than you think. It licenses and inspects manufacturing facilities to ensure they follow Good Manufacturing Practices (GMP); tests products on a smaller scale; evaluates claims and prescription drug advertising to ensure there is no false marketing done; monitors research and reviews clinical trial methods; and creates regulations, guidelines, standards and policies.
It does all of this through its Office of Operations, which contains component offices and centers such as the Center for Drug Evaluation and Research (CDER), the Center ...