A brief description of the FDA’s drug approval process

On Behalf of | Aug 3, 2018 | Uncategorized

If you have ever watched a commercial for a prescription medication on television, you have heard an announcer outline a handful of the side effects, some of which sound quite severe. This may make you wonder how a drug that could cause such serious side effects even makes it to consumers.

You may loosely understand that the Food and Drug Administration is supposed to approve all drugs before they reach you. However, you may wonder what that really means and entails.

How a drug finds its way to you

Pharmaceutical company scientists begin by coming up with a drug compound they believe will help with a particular condition. Companies conduct the first level of testing on animals in order to determine whether the drug is toxic, effective and safe. Thereafter, human trials may begin, but only after receiving approval to do so from the FDA. Below is an outline of the process:

  • The drug’s creator submits an Investigational New Drug application to the FDA that includes information the drug’s composition, results of initial testing and a plan for human testing, among other things.
  • The FDA reviews the application to determine whether the human subjects face any unreasonable risk of harm, receive certain protections and submit an informed consent to participate in the clinical trials.
  • During the first phase of the clinical trials, scientists attempt to identify how the human body metabolizes and excretes the drug and what common side effects occur. These tests often involve anywhere from 20 to 80 healthy individuals and focuses on safety.
  • The second phase usually involves hundreds of people who suffer from a particular condition. The goal is to determine whether the new drug works as a treatment when compared to another group receiving a placebo, with scientists evaluating short-term side effects, along with safety.
  • The third phase involves thousands of people taking different dosages and using the drug in combination with other medications.
  • The process then moves from an investigational application to a new drug application, but before submitting the application, a meeting occurs to review all of the findings obtained from the creation process through the clinical trials.
  • The FDA has up to 60 days to file a new drug application. Once filed, it goes into review status during which reviewers evaluate it for effectiveness and safety.
  • The FDA then reviews the drug’s labeling and takes steps to make sure that medical professionals and consumers receive all of the appropriate information regarding the drug.
  • The FDA then inspects the manufacturing facility.

If everything meets the expectations of the FDA reviewers, then the FDA approves the drug for release into the market.

How a drug still ends up causing harm

You might think that with all of the seemingly rigorous testing and reviewing that a drug goes through that there is no way a dangerous or defective drug could make its way to you. Unfortunately, many drugs slip through the cracks, make it to the market and cause a significant amount of damage and harm to patients like you.

Many drugs are recalled, but the recalls and other warnings often fail to get to you before any harm is done. If you suffered harm from a defective or dangerous drug, you may be entitled to compensation through a product liability claim.