FDA Staff Criticizes Tobacco Product Application Review Process

FDA Staff Criticizes Tobacco Product Application Review Process
FDA's Center for Tobacco Products is accused of lacking scientific independence in pre-market tobacco product applications review.

A commentary states that reviewers of Pre-Market Tobacco Product Applications (PMTA) at the CTP Office of Science lack the authority to exercise "best scientific practices" during their evaluation of PMTAs.

According to the commentary, disagreements in science are not fully suppressed, but are punished through various means of retaliation, such as lack of access to tasks, projects, and other opportunities needed for professional development and progression. In some departments, such as non-clinical science departments, employees are forced to adopt a "must accept" mentality by the leadership, which does not support reviewers in fulfilling their basic duty of providing impartial reviews using the best available science.

According to reports, many comments from staff members of the Food and Drug Administration (FDA) on the performance evaluation of the FDA Center for Tobacco Products (CTP) stated that the regulatory agency is in a state of confusion and is being influenced by external forces rather than scientific research.

In July, the FDA commissioned an independent review of its regulatory practices for food and tobacco, following several months of criticism over its handling of infant formula shortages and e-cigarette reviews. FDA Commissioner Robert Califf selected the non-profit Reagan-Udall Foundation, a non-governmental research group created by Congress to support the FDA's work.

This comment is anonymous and open to the public. Many of the comments depict an incompetent organization whose decisions are swayed by political agenda rather than based on science surrounding the next generation of nicotine products. According to reports, an FDA staff member claims that there is a toxic culture that permeates through the operating system, starting from the leadership team at the FDA.

The commentator wrote, "So-called leaders are not seeking feedback from actual reviewers, but only listening to a few of the loudest voices, who are not experts in any specific field." "Bias and nepotism, unconscious prejudices, racism and sexism, have permeated the entire office and department, and suggestions and feedback from minority groups and women have been ignored, even though they are the ones doing the most work.

Another critique suggests that arbitrary external pressures and politically-driven timelines (such as those imposed by judges) are driving the review process, rather than allowing for a thorough scientific examination. "When errors are found, CTP reviewers are blamed, when in fact there was not enough time allowed for a complete review. Staff are exhausted, constantly told to do more in less time, and blamed for not meeting crazy deadlines," the comment points out. "In cases where the review is completed and a scientific decision is made, they are also overruled by political agendas and forced to change their decision.

Another comment noted that the Tobacco Control Act (TCA) favors combustible tobacco products, allowing new combustible products to enter the market through easier pathways, such as being deemed substantially equivalent (SE) to existing tobacco products.

The CTP has stated that it supports the concept of risk continuum, where combustible products are the most harmful, while non-combustible products may appear safer in name only. However, the CTP has chosen to conduct individual pre-market reviews for new tobacco products," the commentary noted. "Therefore, any innovative products, such as e-cigarettes, will likely have to go through more robust and burdensome market pathways, such as e-cigarette PMTA.

However, it's not all doom and gloom, as some people claim that institution staff are simply overworked. A commentator stated that CTP has been working on impossible deadlines, dealing with a long queue of reviews, something that other FDA-regulated centers don't have to endure.

In comparison, the number of applications and products that it oversees is astronomical, yet we have received no protection, support, or leeway to deal with this burden," the comment stated. "Instead, it seems as though the CTP and OS are being blamed for queuing and not completing tasks on time, without anyone taking a look at how much work is being done to ensure completion as quickly as possible. As for queues and schedules, treating this center like any other is not helpful and only reinforces fatigue.

Another commentator pointed out that the FDA does not have the ability to conduct a "fair and equal" review of all PMTAs, a claim that the agency has denied in court cases surrounding its release of marketing refusals. "There are many layers to ensure that science is meaningful and communicated in a meaningful way. But there is no room for human error or breathing space to apply the system equitably to every application," the commentator noted. "Due to unreasonable deadlines, a lack of protection for personnel outside of CTP, and a shortage of personnel, we are all certainly overworked and stretched thin.


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