Biological products play an increasingly central role in modern medicine, offering treatments for many serious illnesses. Commonly referred to as biologics, these medicines are generally made from natural or living sources, like animal and plant cells, and microorganisms such as bacteria or yeast, and developed using advanced science. They are usually more complex than other drugs and are particularly critical in the treatment of cancer and autoimmune conditions, such as rheumatoid arthritis, psoriasis and inflammatory bowel disease.

Public health and safety is the highest priority at the U.S. Food and Drug Administration. We maintain a robust practice of postmarket surveillance and risk evaluation programs to identify new adverse events that did not appear during the product development process, or to learn more about known adverse events. Evaluations occur on more than two million adverse event reports submitted every year to the FDA Adverse Event Reporting System (FAERS) through the MedWatch Program and to the Vaccine Adverse Event Reporting System (VAERS) by patients, family members, and health care providers, as well as adverse event reports submitted by regulated industry. Staff in our Office of Surveillance and Epidemiology and CBER’s Office of Biostatistics and Epidemiology use this information to identify safety concerns and recommend actions to improve product safety and protect the public.

The U.S. Food and Drug Administration announced that, for the first time, it has authorized the marketing of products through the modified risk tobacco product (MRTP) pathway. The authorizations are for eight Swedish Match USA, Inc. snus smokeless tobacco products sold under the “General” brand name.

Affordable access to medicines is a public health concern and more generic drug competition can help reduce prices, improve access and benefit the public health. Safe, effective and high-quality generic drugs play a vital role in our health care system. Generic drugs account for about 90% of all prescription drug purchases in the U.S. In 2018, competition from generic drugs saved the health care system about $293 billion.