The FDA may speed up the approval process for drugs that have more benefits than risks, including obesity treatments and life-saving antibiotics among other drugs.
The plans would allow drug makers to conduct speedier clinical trials with a smaller group of patients than the agency currently requires.
According to Fulbright, the FDA Commissioner acknowledged the need for to better balance safety and innovation. Details are still being considered as to how a company would later expand this limited approval.
Specific drugs have not yet been identified, though, Arena Pharmaceuticals Inc’s Belviq weight-loss pill and Vivus Inc’s Qsymia are two such examples of drugs that could have benefited from speedier approval processes. Both drugs were first rejected by the FDA in 2010 due to concerns surrounding safety risks. It took the companies an additional two years to justify and bring these drugs to market. In June, Belviq became the first obesity pill approved in 13 years, followed shortly thereafter by Qsymia.