This article is more than 5 years old. Information may no longer be current.

FDA should have more post-market authority

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

WASHINGTON — The Food and Drug Administration “lacks clear and effective processes for making decisions about, and providing management oversight of, postmarket safety issues,” according to a Government Accountability Office report.

Inherent in the problem, the report states, is a lack of criteria for determining what safety actions to take and when to take them.

According to GAO, the FDA may approve a therapeutic with the condition the marketer provide more data later, but lacks the regulatory authority to enforce company compliance.

“To help improve the decision-making process for postmarket drug safety, [GAO] suggests that the Congress consider expanding FDA’s authority to require drug sponsors to conduct postmarket studies when additional data are needed,” the report said.

FDA commented the findings in GAO’s report were “reasonable and consistent with actions that it has already begun or planned.”