The FDA testing process for new drugs
December 29, 2010
Americans rely on the FDA to know which drugs are safe for human consumption, and which are not. All drugs sold legally in the United States must first receive an Investigational New Drug (IND) designation. Without this designation, companies cannot legally ship the drug across state lines. When deciding whether a new drug will be designated an IND, the FDA is concerned primarily with whether research subjects involved in the clinical trials will be exposed to “unreasonable risk.” Applications include “animal pharmacology and toxicology studies,” “chemistry and manufacturing information,” and “clinical protocols and investigator information.” An informational Investigator’s Brochure is also included for those who will be conducting clinical trials.Clinical trials are conducted in three phases. In the first, the drug is tested on a few healthy individuals to determine whether it is acutely toxic. In the second phase, volunteers receive varying dosages to determine what level is appropriate. In the third phase, the drug is tested in a double-blind, placebo-controlled experiment. Before this phase starts, the drug sponsor often networks with the FDA to determine what data is necessary for approval.Before the drug can be sold, the company must submit a New Drug Application (NDA) to the FDA, even if the new drug is a modified version of an older molecular compound. “Substantial evidence” must be shown from the clinical trials to guarantee that the drug will work. Testimonials generally have little bearing on the process. Even if the drug is highly effective, it will not be approved if its side effects outweigh the benefits.The sponsor must produce, and the FDA must approve, the product label, which should give healthcare providers all the information they need to safely use the drug. Depending on whether the NDA is given a standard or accelerated review, it can take from 6 to 10 months for the FDA to make their decision. In addition, a preliminary review can take up to 60 days, during which the FDA determines whether the application is complete enough to warrant a review. While this seems like a long time, it’s well worth the wait for the individuals who will be depending on this medication to be effective and safe.