Is There a Decrease in FDA Regulations?

According to an article in the Economist, FDA’s Commissioner Scott Gottlieb has overseen a fairly significant decrease in the amount of “economically significant” FDA regulations. The piece notes that some criticize the Commissioner for his industry ties. However, his tenure has pushed the agency to make it cheaper and easier for promising medications to reach patients. Issuing Regulations According to the article, FDA regulations have dipped to a two-decade low. The agency has concentrated instead on two areas regarding the development of therapies and medicines. The first area is the adoption of new technologies by the FDA. This includes gene therapy and printed organs. “The FDA is keen to harness the potential of new technologies, whether that means using information from wearables in drug trials or enabling faster approval for new digital therapeutics.” The second area of focus is on getting drunks to the market. The FDA has approved a record number of generic drugs in the past year. This, in turns, increases the amount of competition which is thought to bring the price down. Furthermore, the FDA is also working to limit the amount of burdens on bringing a new drug to market. According to the article, the average cost of bringing a new medicine to market is at $2 Billion, up from $1.2 Billion in 2010. FDA is also working to accelerate clinical trials. The agency is considering lowering the standard of efficacy but not safety. Instead of demonstrating t...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs