14 January 2020 - How has the regulation of prescription drugs evolved from the 1980s to 2018, and what trends have occurred in drug approvals?

Approvals of new generic drugs have increased over time, leading to greater competition. Technological advances have been reflected in increased approvals of biologics over time. The number of expedited development and approval programs has expanded greatly since 1983, reducing the amount of evidence available at the time of approval and increasing uncertainty about the existence or amount of clinical benefit. These regulatory innovations have not clearly led to an increase in new drug approvals or to reduced total development times.

While retaining policies that encourage efficient review, Congress and other government officials should also consider the implications of less rigorous clinical outcome requirements and whether the current complex array of regulatory programs should be simplified.

Read JAMA Special Communication