Investigational New Drugs: The Patient’s Perspective
James E. Hamilton | Friday, June 25th, 2010 | No Comments »In recent years, the FDA has expanded the use of investigational new drugs providing a lifeline to seriously ill patients who have exhausted all other options. Investigational new drugs are not yet approved for general use. However, they are under research by clinical investigators and practicing physicians using subjects who have given their informed consent to participate.
From the patient’s perspective, it is important to consider all of the facts. Patients should contact the manufacturer as well as the FDA for more information. ClinicalTrials.gov is a resource of information on expanded clinical studies. In addition, there are patient advocacy groups that provide assistance. The drug manufacturer, in addition to providing product information, can provide information about the cost of the new drug. It is important to note that most health insurance companies will not pay for investigational new drugs, no matter how seriously ill the patient may be.
There are regular news announcements of promising new drugs in the pipeline for various serious diseases and conditions. With the FDA’s expanded access and the increasing cooperation of the pharmaceutical manufacturers some patients might enjoy a more functional and perhaps extended life.
Helpful Links:
