How Prescription Drugs Get Approved: How Did Yours Make The Cut?

Posted on

No prescription drug makes it to the U.S. market without approval by the The Food and Drug Administration (FDA). All FDA-approved drugs undergo a stringent development process before reaching your pharmacy. The first three steps involve research. The last two steps involve approval and safety monitoring.

The Research and Development Steps

Researchers sift through thousands of molecular compounds to find the small number of them that warrant further testing. Of these that make the initial cut, experiments are conducted to investigate how the compounds react: absorption, metabolization, and excretion, etc. Scientists will further determine dosing levels and toxicity in its preclinical studies. These studies will include both laboratory and animal testing. Once the preclinical safety studies wrap up, then it is on the clinical research.

The clinical step is the most involved stage in all the research. This is where researchers design the clinical trials that will eventually take a new drug to its FDA review. It can take years to complete the process as there are four distinct phases:

  • Phase 1: This is the smallest phase. It's purpose is to determine safety and dosage parameters. There will be 20 to 100 patients who are either healthy or who have the particular disease or condition that a particular medicine will treat. This is the only phase to employ healthy individuals in the clinical study. It will take several months to complete. Seven out of 10 drugs usually go on to phase 2.
  • Phase 2: Several hundred people with the particular disease or condition being studied will participate in this phase. It can last up to two years to determine how well the drug works and what side effects there are. Only about a third of the drugs making it to phase 2 will move on to phase 3.
  • Phase 3: Up to 3,000 volunteers with the particular disease or condition will take part in this long-lasting phase. It can take up to four years to complete phase 3. Around a quarter of the drugs that made it to phase 3 will go on to the final phase.
  • Phase 4: Several thousand volunteers with the particular disease or condition take part in the final phase. This phase further ascertains the safety and efficacy of the proposed drug. The drug's developer reviews the data and determines if the drug is safe and effective. The next step would be to file a marketing application so that the FDA can review the data, and approve, or not approve, the drug.

Steps 4 and 5: The FDA Review and Post-Market Data Monitoring

The final two steps in the drug development process are the FDA review and the marketed drug's safety monitoring. Step 4 is the FDA review process. The developer hands over all the research and development data with their New Drug Application. Once all information is completely submitted and reviewed, the FDA can approve the drug and it can be marketed to consumers. This process take less than a year as a rule.

Step 5 monitors the new drug while it is on the market since the best picture of its efficacy and safety evolves over time. Your pharmacy or drug store may even have a generic version of your prescription eventually. The FDA will review all new information about the drug: new formulations, safety issues, advertising and promotional issues, as well as conducting routine inspections of manufacturer facilities. The entire development process ensures that your next prescription is safe and effective.

Understanding the drug development services and approval process helps you understand where your medications come from.