The Center for Tobacco Products, led by director Brian King, is adopting a comprehensive approach to reform its practices.
Brian King, director of the US Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP), outlined the agency’s response to the Reagan-Udall Foundation evaluation report which found FDA's tobacco program to have a number of wide-ranging issues that make it difficult for it to control the industry and lower the number of tobacco-related illnesses.
The review panel criticized FDA for not being proactive enough and claimed that CTP lacked true clarity, even about its goals, as well as saying the agency has some significant communication issues. It also criticized FDA for being too slow to take action.
First on the list of reforms is the development of a comprehensive 5-year strategic plan, building upon the foundation of the center’s previous strategic plans, which will include advancing health equity as a central tenet and focus on being proactive in its activities.
As suggested in the foundation’s report, CTP will immediately initiate the FDA hiring process to establish a new policy unit under the Office of the Center Director, which would be in charge of providing overall policy coordination across CTP. In order to increase transparency, the agency will also develop, publish, and maintain a full policy agenda of the guidelines and rules that the center is working on or intends to develop. CTP expects to publish the policy agenda by the end of the year, after reviewing its policy development program to ensure a more effective method of providing regulations and guidance that fulfills its strategic goals. After initial release, CTP will update the policy agenda every year.
For premarket tobacco applications (PMTA), CTP will improve communication of its procedures, expedite reviews when feasible, and use its Tobacco Products Scientific Advisory Committee more frequently to examine more general scientific issues that form the foundation for product applications.
In terms of compliance and enforcement, FDA will organize a meeting to examine how it should enforce its compliance efforts with the US Departments of Health and Human Services and Justice. FDA must cooperate with other authorities to investigate businesses that break the law because it lacks the independent authority to file lawsuits or seize products that are being sold illegally.
FDA will also establish a website this spring where it will publish what actions it has taken against corporations that are found to be in breach of the law in order to respond to criticism that the agency was not transparent enough.