The Food and Drug Administration’s (FDA) decisions affect Americans each day, but what is the FDA drug approval process? The process isn’t shrouded in secret. Instead, it’s transparent and easy to understand. If you want to know how new prescription drugs reach the market, keep reading.
1. The FDA Doesn’t Test Drugs
If you were to ask people what the FDA does, the most commonly heard response would be that the FDA tests drugs. Interestingly, that’s precisely what the FDA doesn’t do.
Don’t worry. Drugs are still tested before they’re allowed on the market. However, it’s not the FDA that’s responsible for conducting the tests. That obligation falls squarely on the shoulders of the pharmaceutical firm that’s developing
The manufacturer runs a series of tests known as clinical trials to make sure that the drug is both safe and effective. Afterward, the company presents its findings to the FDA.
In turn, the FDA reviews the trials to ensure that they were conducted according to accepted scientific standards. If the results are favorable, the drug inches closer to approval from the FDA, and thus closer to your neighborhood drugstore.
2. The FDA Acts Fairly Quickly
The FDA has gained a reputation among the general public for acting slowly to approve new drugs. However, the speed at which drugs reach the market has more to do with the manufacturer’s clinical trials.
Clinical trials are expensive and require a great deal of planning and oversight. A drug manufacturer routinely takes years to prepare a drug for submission to the FDA. So, the drug’s fate is in the hands of the FDA for a comparatively short time compared to the time it was under development and testing.
3. Badly Needed Drugs Can Move Faster Through the System
The FDA maintains avenues to bring drugs to the market faster than is typical. This process is reserved for drugs that promise to alleviate suffering on a widespread, perhaps, global basis. Medications used to fight HIV/AIDS received such treatment as did those that targeted COVID-19.
4. A Drug Needs More Benefits Than Risks
Often people wonder why a drug that is banned in the U.S. is available elsewhere in the world. One of the reasons is how the FDA decides whether a drug is safe for public consumption.
The FDA wants to make sure that the recognized benefits of the drug outweigh its known risks. Any medication can react badly with any particular individual; however, the side effects can’t override the patient’s improvement. In other words, the cure can’t be worse than the disease.
5. Non-Prescription Drugs Aren’t Approved By the FDA
The public assumes that every bottle on the shelves of the drugstore underwent FDA approval. However, over-the-counter (OTC) drugs aren’t reviewed by the FDA.
Once again, there’s no need for panic. The FDA does approve the active ingredient in OTC drugs.
That means that the ingredients in your favorite non-steroidal anti-inflammatory pill. It’s just that the FDA doesn’t conduct a new drug approval process for each version of that type of medication produced by a myriad number of competitors.
If there’s a problem with an OTC drug, an investigation can trigger its recall, as mentioned on this site.
You Now Better Understand the FDA Drug Approval Process
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Wayne Probert is a senior reporter at Zobuz, covering state and national politics, and he is a grantee with the Pulitzer Center on Crisis Reporting. Before joining Zobuz, he worked as a freelance journalist in Kentucky, having been published by dozens of outlets including NPR, the Center for Media.