President Donald Trump's call to deregulate the Food and Drug Administration has drawn much attention to the agency's drug approval process, reports Business Insider.
Here's a step-by-step breakdown of how a drug earns FDA approval.
1. Preclinical phase. Before a drug company can test an experimental treatment on humans, it must prove the drug is safe and effective in animals. Scientists run tests in various animals before presenting the data to the FDA as an investigational new drug application. Once the FDA signs off on the application, the company can start testing the drug in humans, reports Business Insider.
2. Phase one clinical trial. In the first round of clinical trials, the drug company attempts to establish the drug's safety in humans. Drug researchers administer the treatment to healthy individuals — instead of patients suffering from the disease the drug is intended to treat — and gradually increase the dose to see if the drug is toxic at higher levels or if any possible side effects occur. These drug trials are usually small, containing about 20 to 80 participants, according to the FDA.
3. Phase two clinical trial. In the second round of clinical trials, researchers give the treatment to patients who have the disease to assess the drug's efficacy. The trial is randomized, meaning half of the study participants receive the drug and half receive a placebo. These trials usually contain hundreds of participants, according to the FDA. There is about a 30 percent chance of a drug moving on to a phase three clinical trial, according to data from the biotech trade organization BIO.
4. Phase three clinical trial. In the third phase of clinical trials, researchers work with the FDA to design a larger trial to test the drug's ideal dosage, patient population and other factors that could decide whether the drug is approved, according to the report. These trials usually contain thousands of participants.
5. New drug application. Once a drug company collects and analyzes all data from the clinical trials, it submits a new drug application to the FDA. The application includes trial data, preclinical information and details on the drug's manufacturing process. If the FDA accepts the application for review, the agency has 10 months — or six months if the drug has priority review status — to make a decision, according to the report. The FDA can hold an advisory committee meeting where independent experts assess the drugmaker's data and recommend whether to approve the drug. From there, the FDA will either approve the drug or give the drugmaker a complete response letter, which explains why the drug did not get approved and what steps the drugmaker must take before resubmitting the application for approval.
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