This is the final post in a brief series of posts (five in total) designed to demystify the high cost of prescription drugs in the U.S. Today’s post focuses on the fourth and final stage the of the FDA drug approval process: post-marketing. Before we dive into the final stage, here’s a quick recap of the blog series:
- Introduction: Overview of the FDA drug approval process
- Preclinical: Compound development, animal testing, and investigational new drug (IND) applications
- Clinical: Clinical trial phases I, II, and III
- NDA Review: Pre-meeting for a new drug application (NDA), the NDA itself, the NDA review process, drug labeling, facilities inspections, and (finally!) drug approval
- Post-Marketing: Clinical trial phase IV
Now, let’s look at the post-marketing stage.
Phase IV Clinical Trials
Once the FDA approves a drug, the post-marketing stage begins, and it lasts the full lifespan of the drug. Throughout this stage, the sponsor is required to submit periodic safety updates to the FDA. Additionally, sponsors often run phase IV clinical trials, which are used to identify and evaluate the long-term effects of new drugs, including efficacy, safety, and side effects.
If you’ve been following this series of posts, you now know that the process of bringing a breakthrough product to market is complex, time-consuming, and costly, but, that it is all in the name of safety and efficacy. The regulations and processes in place trace their roots back to tragic, historical events in which the rights and safety of patients were not properly protected. While it is hard to argue against protecting patients, there is also a competing need to get a life-saving drugs into the hands of the patients that need it, as quickly and cost-effectively as possible.
Because drug sponsors cannot sacrifice compliance or quality, they seek efficiencies in their operations, which are most often realized through leveraging technology. Having the right IT strategy and systems in place helps organizations increase productivity, maximize efficiency, eliminate duplicate efforts, and maintain compliance and quality, all while reducing timelines and cost. This leads to patients receiving the treatments they need, when they need them, at a price they can afford, which is what life sciences is all about.
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