FDA Under Fire for Being Influenced by External Forces

According to some comments submitted to the Center for Tobacco Products (CTP) performance evaluation under the Food and Drug Administration (FDA) given to Reagan-Udall, the FDA is in disarray and influenced by external forces rather than scientific research.

In July, after facing criticism for its handling of shortages in baby formula and the review of electronic cigarettes, the FDA appointed an independent review of its food and tobacco programs. FDA Commissioner Robert Califf chose the Reagan-Udall Foundation, a non-profit research group created by Congress to support the work of the FDA, to carry out the review.

As part of its work, the Reagan-Udall Foundation has been seeking feedback from stakeholders.

Many commentaries depict the image of an institution striving to accomplish its mission.

A commentator stated that the PMTA reviewers at the CTP Office of Science lacked autonomy to exercise "best scientific practices" in reviewing PMTAs prior to their market entrance.

The individual wrote, "Scientific dissent, even if not completely suppressed, is unwelcome and punished through various indirect means (such as a lack of tasks, projects, and other opportunities required for career development/promotion).

In some departments, such as non-clinical scientific departments, the leadership pushes a mentality of "must-haves" onto employees, which does not support the reviewers in fulfilling their basic duties to provide fair reviews using the best available science.

Another commenter claimed that an arbitrary and politically driven timeline set by external forces, such as judges, is driving the review process rather than allowing for a thorough scientific review. "When mistakes are found, CTP reviewers are blamed, when in fact the lack of sufficient time to complete the review is the mistake.

The commentator wrote: "Staff are exhausted and constantly told to do more in even less time, and are blamed for not meeting crazy deadlines. Even when they complete reviews and make scientific decisions, they can be overruled by political agendas and forced to change their decisions.

Statement:

This article is compiled from third-party information and is intended for industry exchange and learning purposes only.

This article does not represent the views of 2FIRSTS and we cannot confirm the authenticity and accuracy of its content. The translation of this article is intended solely for discussion and research within the industry.

Due to limitations in translation abilities, the translated article may not fully express the original content. Therefore, please refer to the original article for accuracy.

2FIRSTS maintains full alignment with the Chinese government on any domestic, Hong Kong, Macau, Taiwan, and foreign-related statements and positions.

The copyright of the compiled information belongs to the original media and author. If there is any infringement, please contact us for deletion.