In order for a pharmaceutical company to market a drug to healthcare providers and consumers, they must go through the U.S. Food & Drug Administration (FDA) approval process. This process takes, on average, around 12 years to complete. From laboratory to pharmacy shelves, the cost of the FDA approval process costs around $350 million per drug.

The goal of the FDA approval process is to ensure that the drugs marketed and distributed to consumers are safe and effective. Sadly, even with millions of dollars and more than a decade of study and tests, many drugs that make it to consumers are not as safe or effective as they should be.

At Drug and Device Watch, we advocate for safe and effective drugs. When the drugs you are prescribed to restore you do more harm than good, you deserve answers. Often times, those answers can be found by investigating the FDA approval process, including the clinical trials, testing, and marketing.  

The FDA Approval Process

When pharmaceutical companies, called sponsors, decide they want to market a new drug, they must proceed through a series of FDA processes. These include:

Pre-Clinical Process:

  • Drug Development: The sponsor develops the drug or compound.
  • Animal Testing: The sponsor conducts tests on animals in order to determine the safety and effectiveness of the drug.
  • Application: The sponsor submits an Investigational New Drug (NDA) Application to the FDA.

Clinical Process:

  • Phase 1: Phase 1 of the clinical process focuses on safety. In this phase, 20-80 volunteers take the drug so that the FDA can determine the most common side effects, how the drug is metabolized in the body, and how it is excreted.
  • Phase 2: Phase 2 focuses on effectiveness. In this phase, hundreds of volunteers take the drug, with the FDA recording data on how the drug works in volunteers with various medical conditions or diseases. Controlled trials involve studying patients taking the drug compared to patients taking a placebo. Safety, effectiveness, and side effects are recorded.
  • Phase 3: Phase 3 focuses on how the drug affects different populations, how different dosages effect volunteers, and how it reacts with other drugs. This phase usually consists of thousands of volunteers.

NDA Review:

  • Review Meeting: The FDA holds a review meeting with the sponsor prior to official filing of the NDA.
  • NDA Application: The sponsor formally asks the FDA to approve the drug for marketing in the United States. This stage of the process includes the sponsor submitting all documentation about animal and human testing, and how the drug interacts with the human body.
  • Application Review: The FDA has 60 days to review the NDA and make a decision about the drug. A team is assigned to review the NDA and evaluate the drug for safety and effectiveness.
  • Drug Labeling: The FDA will review the professional labeling on the drug and ensure that it contains all appropriate information. The FDA will determine if the label communicates appropriate information to healthcare providers and consumers.
  • Inspection: The FDA conducts an inspection of the facility or facilities where the drug is manufactured.
  • Approval: The FDA makes its final decision and either approves the drug, or issues a response letter to the sponsor.

Post-Marketing:

  • Phase 4: Phase 4 is the FDA’s continued and ongoing involvement in monitoring the drug and ensuring that it meets safety and effectiveness standards. Periodic safety updates will be required from sponsors. During this phase, the FDA will also investigate consumer complaints or adverse events reports. If a drug is found to be dangerous or defective, then the FDA may proceed with a recall.

It is important to remember that the FDA’s review and decision process is based on safety and effectiveness studies and tests provided by the sponsor. If these documents are altered or fraudulent, then the FDA could approve a drug that is actually not as safe or effective as the sponsor has led them to believe.

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