Modern medicine has helped save countless lives over the past two centuries. Insulin, penicillin, the polio virus, and other drugs have kept many deadly illnesses at bay. The pharmaceutical industry does not distribute drugs as soon as they suspect that the drug might be able to cure or alleviate these diseases. Most drugs must undergo a lengthy and tedious testing and trial process before they can be considered safe and effective in treatment. The Drug Development Process has five distinct steps, including discovery and development; preclinical studies; clinical trials and FDA reviews.
According to FDA, the FDA defines the first stage as discovery and Development. Laura Lansdowne explains this process in her article, “Target Identification & Validation in Drug Discovery”. She argues that drug development begins when scientists discover a good “target”, which is a biochemical entity that has both a role in disease as well as the ability to be altered by therapeutic methods. It’s a process of finding the “causes” of disease, so the new drug can be developed. Target validation is then performed, which involves a series of experiments on the target in question to confirm it plays a part in the illness. After that, drug development begins. Scientists now look for drugs that have the ability to affect a target. In this stage, tens of thousands of compounds are tested and screened using a brute force trial-and-error approach. Scientists then modify and further develop drugs that have passed testing in order to improve their effects on target. Toxicology is used to determine the dangers that a drug could pose. In vitro studies, in which experiments are done in Petri dishes or test tubes, and in-vivo studies, in which experiments are done on mice, rats, and monkeys are the two most common methods used to conduct these tests. Preclinical studies are required to provide information about dosing, toxicity, and other factors. This is important, as the FDA says, because dangerous drugs may be used in clinical trials on humans.
Scientists must first fill out an Investigational New Drug Application, which includes information on manufacturing and previous research data. Then, Phase I of clinical research is conducted, in which the drug in question will be tested on 20 to 100 patients with the disease. Scientists spend several months in this phase to test the safety of a drug and determine its dosage. Phase II is the next phase and involves testing hundreds of people. The next phase, Phase II, is a series of tests with hundreds of participants. Phase III and Phase III are similar, but the biggest difference is in the size of the experiments. This stage may involve up to a thousand participants over a period of four years.
The FDA will only approve the release of a drug after the clinical trial is completed. This is the stage where developers submit an NDA along with all of the data they have collected in previous steps. The FDA Review Team decides whether to approve or reject a new drug after 6-10 months. The FDA may, in certain cases, ask the drug developer to address specific issues regarding the drug. Delaying approval can be a result.
The FDA must still ensure that the drug will be safe once it hits the market, even if the drug has been approved. The FDA can receive Form FDA3500 from healthcare professionals who find problems with a drug. Consumers can also report issues by using Form FDA3500B. Form FDA3500A is required from the manufacturer and importer of the drug if they believe that their device may have been responsible for a death, serious injury, or both. The FDA also actively monitors databases of health information to detect any potential problems. The FDA’s Sentinel Initiative uses the Sentinel System which is a statistical, data-science, and other tools to detect problems in real time.
Drug Development Processes are not easy. The Drug Development Process is not a simple one. The fact that there are laws and regulations in place that protect American consumers is reassuring.
Works Cited
The Center for Devices and Radiological Health provides services related to medical devices and radiation safety. “Mandatory Reporting Requirements.” U.S. Food and Drug Administration, FDA, www.fda.gov/medical-devices/postmarket-requirements-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities.
The Center for Drug Evaluation and Research is a government agency that oversees the safety and effectiveness of drugs. “FDA’s Sentinel Initiative.” U.S. Food and Drug Administration, FDA, www.fda.gov/safety/fdas-sentinel-initiative.
“The Drug Development Process.” U.S. Food and Drug Administration, FDA, www.fda.gov/patients/learn-about-drug-and-device-approvals/drug-development-process.
“Reporting Serious Problems to FDA.” U.S. Food and Drug Administration, FDA, www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda.
“Step 3: Clinical Research.” U.S. Food and Drug Administration, FDA, www.fda.gov/patients/drug-development-process/step-3-clinical-research.
“Step 4: FDA Drug Review.” U.S. Food and Drug Administration, FDA, www.fda.gov/patients/drug-development-process/step-4-fda-drug-review.
Lansdowne, Elizabeth. “Target Identification & Validation in Drug Discovery.” Drug Discovery from Technology Networks, www.technologynetworks.com/drug-discovery/articles/target-identification-validation-in-drug-discovery-312290.
Compound interest, 5 April. 2017, www.compoundchem.com/2016/01/16/drug-discovery/.
