The FDA Approval Process
American consumers have access to some of the safest and most advanced pharmaceutical systems on the world. However, that system is not flawless.
Process Overview
The process of developing and testing a new drug is extensive. Once a company develops a drug, it undergoes more than three years of lab testing before an application is even made to the Food and Drug Administration (FDA). It then takes the FDA about eight years to complete its clinical testing. Because some patients who are terminally ill cannot wait that long for a drug, efforts are underway to reduce this lengthy approval time.
Pre-Clinical Research Stage
The first step is pre-clinical research, where the new drug is synthesized and purified. Animal tests are performed, and an institutional review board will assess these research findings and make a recommendation on how to proceed. If the recommendation is to move forward, the drug company will make an application to the FDA and clinical tests on human subjects will begin. Only one in every 1,000 or so compounds that enter laboratory testing will ever make it to the human testing phase.
Clinical Testing Phases
Phase 1 uses between 20 and 80 healthy volunteers or patients to establish a drug’s safety and profile. This step takes about one year and focuses on the drug’s:
- Structure-reactivity relationship
- Metabolism
- Mechanism of action
- Side effects
Phase 2 involves between 100 and 300 patient volunteers to assess the drug’s effectiveness. This step takes about two years, treating patients with a specific disease or condition. The studies in phase 2 are conducted on a larger scale, making it more effective for learning about short-term risks and side effects.
Phase 3 uses between 1,000 and 3,000 patients in clinics and hospitals. Test subjects are carefully monitored to determine the drug’s effectiveness and any other adverse reactions over a three year period.
The FDA Application
Following these clinical trials, the drug’s manufacturing company will submit an application to the FDA for final approval. This application can be up to 100,000 pages long, and take up to two-and-a-half years to be approved. Once the FDA approves the drug, it becomes available for prescription and public sale. The drug company must continue to monitor the drug and report any adverse reactions and other follow-up data to the FDA.
Problems with Clinical Testing
One major problem with clinical testing trials is that the long-term consequences of a drug cannot be evaluated. In an attempt to assess the long-term impact of new pharmaceuticals, drug companies are instructed to conduct post-marketing studies as a condition of FDA approval. However, few of these lucrative pharmaceutical companies take the post-marketing studies seriously because the FDA has little enforcement power once it approves a drug.
You Can Help the FDA Regulate Dangerous Drugs
The possibility of pharmaceutical injury is constantly increasing as hundreds of new pharmaceuticals and medical devices are approved each year.
Once the FDA approves a drug, it cannot force the drug company perform post-approval safety reviews. Because of this, consumers have the responsibility to watch their drugs and devices carefully to identify any adverse side effects or complications. By paying close attention, you can help get dangerous and defective drugs recalled and removed from the marketplace before they injure a significant number of consumers.
Article Source : The Cochran Firm – The Fda Approval Process : ArticleBase
Erich Shrefler
If you have been hurt by a defective drug, please visit the website for The Cochran Firm to learn more. We serve clients nationwide.
Posted on February 13th, 2010 | By: admin | Filed under Plaintiff Lawsuit Funding