New Drug Approval Process

Statistics indicate that the development and approval process of a new drug can take between 12 to 15 years. A drug manufacturing company incurs approximately $2.6 billion to get a new drug from the lab to pharmacies.

Scientists worldwide are dedicated to finding treatments and cures for various diseases that threaten humanity. The Food and Drug Administration (FDA) defines a drug as any product that is used for cure mitigation, diagnosis, or prevention of diseases.

The FDA Center for Drug Evaluation and Research (CDER) is the regulating agency for potential medication seeking approval for use in the United States. The following are the stages of the new drug approval process.

Phase 1: Discovery and Development

During this stage, scientists find new possibilities for medication through molecular testing. They also evaluate the effects from existing treatments or develop new technologies that allow different ways of administering medical products to the body.

Additionally, research is conducted on the following:

  • The appropriate dosage
  • The method of drug administration
  • Side effects and how they may vary on different demographics
  • The effectiveness of the drug compared to similar compounds
  • The drug interaction with the body
  • How the drug is absorbed and metabolized in the body

Phase II: Pre-Clinical Trials

Once the drug sponsor (usually the pharmaceutical company) has examined the possibility the drug may have a particular disease, they must test the drug to determine its toxicity (its ability to cause harm) by testing on various animal species. Researchers are required to follow a particular set of laboratory guidelines during this stage.

Pre-clinical trials are smaller than most clinical trials. However, they must generate data and information on the safety and toxicity levels of the compounds being investigated. If the safety results are promising, the pharmaceutical company submits a formal request to the FDA known as Investigational Drug Application (IND). The application must contain pre-testing details, the drug’s composition, and a plan for human trials.

If the FDA reviews the application and finds the drug is safe for human testing, they give it a nod for the next development phase.

Phase III: Clinical Trials

Once the pharmaceutical company gets an IND approval, they examine how the drug interacts with the human body. These trials involve testing of the drug on people. This is the most involved and vital process in the new drug approval process. The results of clinical trials must answer certain questions developed by the drug researcher. They design a clinical study by determining the participants and the method of data collection and analysis. The following are the sub-phases of clinical trials.

Phase I: This stage Involves administering the drug to a relatively small number of healthy participants, typically less than 100. This phase aims to determine the safety of the drug by examining its side effects, metabolism, and excretion. If successful, the trials can proceed to the next stage; if not, the trials are canceled.

Phase II: Once the drug is deemed safe, a larger number of participants (typically 100) with certain diseases or conditions are given the drug. This phase aims to determine the effectiveness, safety, and side effects of the drug. This phase is a controlled research, involving comparisons of the results from those administered with the actual drug and those given a placebo (a non-active drug). This stage lasts from a few months to two years, and only around 30% of drugs make it to the next phase.

Phase III: Involves a large sample of participants (typically 1000s) and can last up to four years. The trials gather more information on the drug’s effectiveness on different demographics, long-term adverse effects, and its effect when combined with other medication. About 25% to 30% of these drugs advance to the final phase.

Phase IV: Thousands of participants with the diseases or conditions are monitored for safety and efficacy. If successful, it can advance to the New Drug Application (NDA) review.

Phase IV: Review by the FDA

Once the drug sponsor proves that the drug is safe and effective to use through pre-clinical and clinical trials, they file an application with the FDA to allow the marketing of the drug. The application must contain:

  • Clinical trials results
  • Labeling information
  • Potential for drug abuse
  • Safety Information
  • Directions for use
  • Patient information

Once the application is complete, the FDA team takes almost ten months to make a decision. In case there are issues, the team may request additional data before making a decision. If the FDA team gives a green light, the manufacturing company can move to the next phase.

Phase V: Post Marketing and Post Approval Risk Assessment

During this stage, the drug’s safety is monitored after it’s on the market, and an FDA drug safety expert detects any adverse events that were not possible to detect in the clinical trials. The manufacturing company must provide FDA with periodic updates and data.

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