March 7, 2024
Nearly 280,000 facilities, with more than half of those outside the United States, manufacture medications, vaccines, cosmetics and other products that must be approved by the U.S. Food and Drug Administration before they can be sold in this country, Dr. Anne-Laura Cook, an internal medicine physician with University Medical Center, said during a February Mini Medical School presentation.
In 2023, the FDA reviewed more than $2.1 trillion worth of products manufactured both in the United States and abroad.
The FDA is one of 12 divisions of the U.S. Department of Health and Human Services, and its mission is to protect the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, foods, cosmetics and products that emit radiation.
“The FDA is charged with making sure medical and other products are reviewed and approved in a speedier fashion,” Cook said.
Mini Medical School is a series of lectures provided each semester by UMC health care providers to UA’s Osher Lifelong Learning Institute (OLLI) members.
Beginning in 1848 as the Division of Chemistry, and then in 1901 as the Bureau of Chemistry, the FDA was officially established in 1906 when the Pure Food and Drugs Act was passed.
“This act prohibited the interstate transport of unlawful food and drugs under penalty of seizure of questionable products and prosecution of the responsible parties,” Cook said. “The act (today) is really focused on the labeling of products to make sure that the product says and does what it is supposed to do.”
Cook said the FDA also regulates the manufacturing, marketing and distribution of tobacco products and is charged with discouraging tobacco use by minors.
The FDA’s approval process is broken down into five steps: discovery and development, preclinical research, clinical research, drug review and post-market drug safety monitoring.
“The FDA does not develop new therapies or conduct clinical trials,” Cook said.
Once enough evidence and data are gathered demonstrating that a product is safe and effective, the company applies to get FDA approval. A team of FDA experts evaluates the clinical trial and other research to ensure the product meets FDA standards, including safety, quality, efficacy and if the benefit of the product outweighs the risks.
Cook said if the standards are met, the FDA inspects the facility where the product is made to make sure it meets manufacturing standards.
“If the FDA team determines the research data and evidence showing that the product is safe and effective for intended use, the FDA approves the product,” said Cook. “Once the product is approved and is out in the market, the FDA continues to monitor the product safety, effectiveness and quality for years to come.”
If a product shows evidence of safety complications in certain populations, the FDA has the right to pull it off the market.
“When you reach for your prescription medications, you trust that the medicine is going to do what it is supposed to do and that is to make you feel better,” Cook said. “That trust comes from knowing that teams of doctors, biologists and chemists of FDA are working tirelessly to protect the health of the American public by making careful and informed decisions about which new drugs to approve.”
For more information about the FDA, visit here.
