The FDA's process for approving drugs for human use can seem mysterious and convoluted. Created in 1906, the Food and Drug Administration originally didn't have the legal power to demand drug recalls. Their main purpose was to make creating and marketing food and medicines to the public safer. The process has been refined over time to better address the needs of consumers and companies. Currently, drug approval consists of Pre-Clinical Research, Clinical Trials, and Approval For Marketing.

Pre-Clinical Stage

This is the starting point for any new drug. Once the medication is created and refined, testing using animal subjects begins. After the company has compiled results, their data is submitted to the Center for Drug Evaluation and Research, the arm of the FDA that oversees this operation. An in-house panel looks over the numbers to see if they find the safety predictions credible. Very few drugs ever get past this first stage. The ones that do are allowed to recruit human subjects for clinical trials.

Clinical Trials

Trials happen in a few steps. First, healthy volunteers are used so the fundamental actions of the medicine on the human body can be recorded. This usually consists of tracking both how the drug is metabolized and what side effects occur.

If that goes well, the second stage involves recruiting people with the condition the medication is supposed to treat. These folks are worked with outside of a hospital setting. The goal at this point is to learn about and record short-term side effects.

In the last stages of clinical trials, large pools of volunteers in hospitals are studied over a longer period of time. The idea here is to continue to monitor drug interactions, looking mainly at long term side effects. This part of the process is especially important in avoiding approval of drugs that may cause death, such as with Fentanyl and Heparin.

Approval For Marketing/Standard Review

This is the phase most people are familiar with. After trials are all done, the company brings the data together in an application asking for the right to take the drug public. It can be a long process, but once approval is given, the drug can be officially dispensed, bought and sold.

Approval/Accelerated Review

Developed in 1992 partially due to the AIDS crisis, accelerated review cuts down the time it takes to get a drug to market. It has to either fill an unmet need or treat a life-threatening condition more effectively than anything else available. On average, accelerated drugs can be approved in around a year.

Afterward

What does all this mean for you? The risk of personal injury from new drugs is still great. The FDA usually only pays attention to "serious adverse effects" like death, and post market monitoring by companies is voluntary. Your life is valuable. If you or someone you love is hurt by the effects of a drug and you live in California, it may be in your best interest to talk to a professional Los Angeles personal injury lawyer.