The U.S. Food and Drug Administration (FDA) is quite an impressive agency. They regulate the safety and security of all foods that are produced, imported, or created in any other way for the American people. As if that weren’t enough, this same governmental organization is also responsible for the testing and approval of all medication allowed on the market, both over the counter and by prescription. That’s every drug for every ailment from the common cold and itch relieving ointment to chemotherapy and radiation.
They also cover all the exotic diseases, like paroxysmal nocturnal hemoglobinuria (PNH) and Hutchinson-Gilford progeria.
The amount of effort that goes into approving these medications is impressive. There must be numerous clinical trials. The evidence produced in said trials must have statistical significance. The evidence must be confirmed by double-blind studies, meaning that neither the patient nor the doctor knows who gets the medicine and who gets the control. The logistics and paperwork involved in such an operation are mindboggling.
Again, if this list of responsibilities was not impressive enough, there is still the little part of the process that requires proper advertising and notification of possible side effects that must be dispersed to the public. The FDA ensures that the advertisements are factual and substantiated by evidence. They’re responsible for that folded up piece of paper inside the box or under the label of your favorite medications.
This impressive number of feats is accomplished with a remarkably high degree of accuracy. It is all too easy to fall into the trap of thinking that the FDA makes lots of mistakes because drugs have been approved then later recalled. It is less easy to fall into this trap once you realize how many drugs are tested in a given year. That number is in the thousands. It takes, on average, more than eight years for a drug to be developed, tested, and approved.
Of course, no one, and especially no government agency, is perfect, but given the task on their hands, the FDA should be given their appropriate due.
You can read more about the testing process for a new PNH drug by clicking here.
