23 May 2018 - The US FDA oversees several programs that expedite approval of certain drugs that treat serious conditions and address unmet medical needs. 

On average, a drug in an expedited program reaches market almost a year sooner than other drugs. However, expediting drug approvals raises concerns that important safety or effectiveness information will be missed, potentially heightening risk of patient harm.

Most new drugs are approved with relatively little data about long-term outcomes. More than two-thirds of approvals are based on studies lasting less than 6 months. The FDA approves novel therapeutic agents more quickly than do similar regulatory bodies in Europe and Canada, with the median time for cancer drug approval of 6 months. Expedited reviews have increased in the last 2 decades, driven by drugs that are not first in their class, implying that they do not address unmet needs, according to a study by Aaron Kesselheim, MD, JD, MPH, of Harvard Medical School in Boston, and colleagues.

Read JAMA Forum article