The 1960s are a time remembered either fondly or distastefully, depending on your designated family historian. If a friend or family member happens to be a medical professional, they will note one important event in their field which lay audiences may not be entirely familiar with, the tale of the, “thalidomide disaster.”
In the late 1950s the drug thalidomide was introduced to the world as a safe sedative and anxiolytic. In the 1960s the drug was marketed in 46 countries and, as occurs with many popular drugs, began to be used off-label. The particular indication was morning sickness. Not long after, doctors began to notice horrible birth defects such as phocomelia (shortening or absence of limbs) and flipper-like limbs in children born to mothers taking thalidomide. Around this time, the U.S. FDA realized the complete lack of evidence surrounding the safety of thalidomide and blocked its approval in the United States. This disaster not only woke up our FDA but led to a new era of increased regulatory surveillance of clinical trials and a greatly lengthened drug approval process throughout the world.
Along with a much safer approval process, the next few decades brought a transformation in the world’s interconnectivity and technological prowess. Pharmaceutical companies were developing seemingly endless drug pipelines and expanding continually into new markets, each with their own regulatory body. Thus, the ICH was born in 1990 out of necessity for more standardized, or harmonized, regulatory requirements between countries.
The ICH was originally a partnership between the regulatory industries of Europe, Japan, and the United States but is now a global organization. ICH’s mission is to:
“make recommendations towards achieving greater harmonisation in the interpretation and application of technical guidelines and requirements for pharmaceutical product registration, thereby reducing or obviating duplication of testing carried out during the research and development of new human medicines.
Specifically, the ICH develops consensus guidelines based on input from the World Health Organization, regulatory and industry experts, Drug Regulatory Authorities, and Departments of Health in order to promote greater synchronization between regulatory bodies of different nations. Please go to their website www.ich.org for additional information. While attaining regulatory approval can be quite cumbersome for both young and established companies alike, we are lucky to have organizations such as the FDA and ICH working to prevent disasters such as that caused by thalidomide not so long ago.