What Goes Into Approving a New Drug?

When a new medication is created by a pharmaceutical company, this is nowhere near the end of the road for getting it approved. In order to have their medicine prescribed or sold, drug sponsors must submit to a long and rigorous process of approval. When companies fail to complete these requirements, submit untrue or misleading data, or any steps are skipped, negligence has occurred and can lead to injury and death of those taking the medication. In fact, a study performed with the American Association for the Advancement of Science (AAAS) found that 27% of scientists encountered some form of misconduct during these drug trials

Let’s review the Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) and the steps needed to pass board approval for a new drug. 

Step 1: Development of New Drug and Animal Testing

Once a drug is developed by a pharmaceutical company, it must be first tested on non-human subjects. This can include a variety of animals, like mice, birds, domestic animals, and apes. The goal of such testing is to establish any potential threats to living creatures prior to the necessary human clinical trials. Once these animal testing phases have been completed, the drug company can then submit an Investigational New Drug (IND) permit that lays out the drug’s composition, manufacturing details, and the company’s plans for testing the drug on humans. 

Step 2: Clinical Studies and Trials for New Drug

When the IND permit has been formally approved by the CDER’s team of physicians, chemists, statisticians, and pharmacologists, it can then enter into a series of clinical trials on humans. These tests have three phases, each one escalating in terms of size and scope.

  • Phase One

In the initial phase of clinical studies, drug companies use 20-80 healthy volunteers to determine what side effects exist and how the drug is metabolized and then later passed out of the body 

  • Phase Two 

The second phase is all about proving the effectiveness of the drug. Clinical trials will be performed on a few hundred people all suffering from the illness or condition the medicine is claimed to treat.

  • Phase Three

Finally, clinical testing expands to thousands of people to prove effectiveness but on a wider scale. 

Step Three: New Drug Application (NDA) Review

Once clinical trials have been performed and approved, it’s time for the Food and Drug Administration to meet and review the medication in question. The drug sponsor’s application must include all relevant animal and human testing data, chemical analyses of the drug, and marketing plans for the medication. This includes how many people the marketing will reach, and where it will be distributed. 

Once the NDA application has been submitted, the FDA has 60 days to make a decision on whether they want more information. If the FDA thinks the current evidence is enough, more reviews are performed, including on the medicine’s labeling and the facilities where it’s manufactured. If all this goes well, the drug can finally be approved for public sale. 

The approval process of a new drug is a long and detailed one. These steps have been put in place to help avoid dangerous side effects on those taking it or producing it. If any corners are cut, or data is incorrectly submitted or forged, this is a form of negligence that can be pursued in case of product liability or medical negligence case. If you’ve taken a prescription that wasn’t adequately tested or should not have been prescribed to you, contact the Indiana personal injury attorneys at Christie Farrell Lee & Bell We want to be your advocate in the courtroom to help you get the compensation you need to move on in life with peace of mind.

Dial (317) 245-3709 or send us a message online to discuss your legal options.