The FDA’s Drug Approval Process – Part 2 of a 3-part series

by Christie Bell, CLP

The timeline, steps and cost.

When not expedited by special programs, the standard drug development process can take from 10-15 years. For more in-depth information on the four special programs (Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review) please review Part 1 of this 3-part series. 

The path to FDA approval starts with Step 1, Discovery and Development. In this phase, researchers in the laboratory gain new insights into a disease process and begin design on a product to slow, stop, or reverse a disease. Tests of molecular compounds are conducted to find beneficial effects, and thousands of new chemical combinations may be considered, tested, eliminated or advanced. Precursors to the potential new drug can evolve from many sources including unanticipated effects of existing treatments and novel technologies that provide new ways to target medical products. 

In Step 2, Preclinical Research, scientists determine whether the prospective solutions have the potential to cause serious harm, also called toxicity. General tests are initially conducted in vitro, or in glass or plastic vessels in the laboratory. In vitro is followed by in vivo testing, which means the testing is conducted in a living organism. Animal models are nearly almost always used before testing is allowed in humans. There are regulations that cover in vitro and in vivo testing including standards for study conduct, personnel, facilities, equipment, written protocols, operating procedures, study reports, and quality assurance oversight. 

Clinical Research is Step 3 in the process. During this stage, testing on humans is carried out to be sure the drug is safe and effective. This phase, also known as clinical trials, adheres to a protocol designed and proposed by the inventors of the product who work for a research institution, university, private laboratory or manufacturing operation. The study designer uses the protocol and guidelines to determine factors such as qualifications of participants, number of people in the study, duration of the study, and whether there will be a control group to help eliminate bias. Assessments are conducted during the trial, and data is collected, reviewed, and analyzed. 

During Step 4, the drug developers complete and submit a New Drug Application (NDA). The NDA describes the drug from early conception to the outcome of the trials. Along with the NDA, the clinician submits the proposed labeling, safety updates, drug abuse information, patient information, international studies, institutional review board (IRB) compliance information and directions for use. If the NDA is considered complete, the review team has 6 to 10 months to decide on whether to approve the drug. 

Step 5 is the last step of the process, and it marks the beginning of the Post-marketing Drug Safety Monitoring phase. The true picture of a product’s safety evolves over the months and even years after entering the marketplace. Concerns, observations, and side effects that arise in the prescription and over-the-counter drug marketplace are reviewed. Measures can then be taken to resolve the limitations discovered in the post-marketing phase. According to a study of 63 new therapeutic drugs and biologics published in Jama Network in 2020, the median cost of bringing a new drug to market is about $985 million.

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