What process does a new drug go through before it reaches the marketplace?
The Federal organization charged with regulating and approving any drug placed in the U.S. marketplace is the U.S. Food and Drug Administration (FDA). Each year, the FDA is responsible for regulating an estimated $1 trillion worth of products, with pharmaceuticals representing a large percentage of these products.
The pharmaceutical manufacturing industry reports that it takes, on average, 12 years and purportedly over $350 million to get each new drug from the drawing board to laboratory and onto the pharmacy shelf. Once a pharmaceutical company develops a new drug, it undergoes approximately three and a half years of laboratory testing, before an application is made to the U.S. Food and Drug Administration (FDA) to begin testing the drug in humans. Only one in 1000 of the compounds that enter the pharmaceutical manufacturer’s laboratory will ever end up being tested on a human being.
If the FDA eventually gives the green light, the “investigative” drug will then enter three phases of clinical trials: 1) Phase 1 employs a group of 20-80 healthy volunteers. This test’s end goal is to establish a drug’s safety and profile. Phase 1 normally takes one year to achieve the data necessary to advance to the next phase; 2) Phase 2 consists of a larger group, 100-300 patient volunteers, to assess the drug’s effectiveness, and lasts about two (2) years; and 3) Phase 3, the final phase, involves involved a much larger test group, 1000-3000 patients, located in clinics and hospitals who are monitored carefully to determine effectiveness and identify any adverse reactions. This process takes an additional three (3) years.). Upon completion of the three phases, the company then submits an application to the FDA for approval, a process that can take an additional two and a half years. After final FDA approval, the drug enters the commercial market and becomes available for physicians to prescribe. At this stage, the drug company is charged with ongoing testing and must continue to report any incidents revealing adverse reactions discovered, and other clinical data the drug company collects, to the FDA.
While the testing process described above seems complete and comprehensive it is significant to note that the majority of the testing activities are conducted under the exclusive direction and control of the pharmaceutical manufacturer itself. Some critics of this arrangement have suggested that the drug companies, in an effort to promote their own self interest for profit and getting their product to the market in as short a time period as possible, may take short cuts at the expense of potential consumers to have a drug approved and placed into the stream of commerce.
Questions about how a drug gets approved to be sold to the public? Concerns about your rights if a defective medicine causes you to be injured? Call the Law Office of Dan Newlin & Partners today. We would be honored to answer any questions you may have about Pharmaceutical Malpractice and defective drugs. Help is just a phone call away. Call (407) 888-8000. In a free phone call you can get valuable information to help you receive all the benefits you deserve and protect all of your legal rights if you are injured as the result of a defective drug. Call us now.