FDA Creates Process to Expedite Approval of Revolutionary Drugs
On average, a new drug brought to market in the United States requires $1 billion spent over 10 years in order to meet the stringent standards of the U.S. Food and Drug Administration (FDA). In 2012, however, the FDA sought out ways to ameliorate these high costs and lengthy delays of bringing breakthrough drugs to pharmacies across the country, creating a new program that expedites the process for medicines that show evidence of having major benefits for people with serious injuries and illnesses. Since then, more than 50 drugs have been admitted to the program, including new treatments for blood cancers, cystic fibrosis, and hepatitis C. For pharmaceutical companies and patients alike, this has been a major boon in many cases. One drug spent only six years between its initial trials and ultimate approval after inclusion in the new FDA program. Some observers have criticized the degree to which the FDA’s new process has complicated both pricing considerations and marketing concerns, but the FDA itself has declared the program an unqualified success. Industry experts consider it likely that in the coming years, the effects of the FDA’s new rules will make it much easier for promising drug candidates to reach American hospitals.