On any given day, almost everyone deals with medication. It may be a few aspirin for a headache or an antibiotic for a sick child, or countless other products. Whatever the product and whatever the purpose, it has its roots in laboratory and a resulting FDA approval process.
We all know that’s how new drugs come about, but what is that process really like? Generally speaking, drugs go through a process of five steps to reach your local pharmacy.
This is the obvious step, where a particular compound is created in order to address a particular health issue. It seems fairly straightforward, but there can be a lot of logistical issues involved due to the long time it takes to get the chemistry of the product to exactly the right composition. The process must be carefully managed during transitions in personnel, situations that have the laboratory moving to a new location, and changes in funding.
- Preclinical Testing
Next is the process of verifying that the product does indeed achieve what the researchers are hoping it will achieve. This also involves testing for potential side effects and adverse reactions. It can also encompass testing the products chemically in test tubes as well as in test animals, such as laboratory mice. There must be satisfactory results in terms of both efficacy and safety before the process can proceed to the next step.
- Clinical Testing
That next step is actual use in humans. This process takes place over a period of years, and it works its way up from very small groups to much larger populations of test subjects. This allows the researchers to minimize the number of people exposed to the risks associated with a drug that is still largely unproven. As it is proven safer through each step, the number of subjects is increased to see if the health results can be replicated.
- FDA Review
At this point, the researcher submits all pertinent applications and data results to the FDA for review. The agency examines these documents and verifies that appropriate standards have been met. There may be a request made for additional data or for clarification of the information provided, but over a period of months, the drug completes the process and is ready to be placed on the market and prescribed by health care providers.
- Ongoing FDA Monitoring
Occasionally a drug successfully navigates the first four steps, only to be determined later to have dangerous side effects, undetected allergic properties, or just inadequate performance. The FDA continuously monitors medications, particularly immediately after their release, to ensure that any such unintended outcomes are quickly addressed by the manufacturer, either with recalls, the provision of additional information to patients, or perhaps even through a complete removal from the market.
When we have a medical condition and can quickly address it by simply taking a few pills each day, we can underestimate just how hard it was to get that product to us. This is the reason for the frequent public discontent when a new condition such as HIV emerges and is not immediately addressed with a new pharmaceutical.
While it can be a frustrating process, particularly for those who desperately need treatment, the fact is that the process is extremely important and must be slow and deliberate. Each step contains many layers of review and verification so that when a product finally hits the shelves, patients can have a high level of confidence that it will perform as advertised with minimal risk of detrimental side effects or reactions.