Bowling Green Today

In a joint effort to prioritize harm reduction in the United States, Senators Rand Paul, Joe Manchin, and Ted Budd have sent a letter to Dr. Robert Califf, Commissioner of Food and Drugs at the U.S. Food and Drug Administration (FDA), urging the FDA Center for Tobacco Products (CTP) to reform its application review process for harm-reduced products. The senators are also seeking information about CTP's policies and actions to ensure that it is acting efficiently and based on scientific evidence.

Cigarette smoking remains the leading cause of preventable disease and death in the United States, with nearly 31 million Americans still smoking. Recognizing the importance of harm reduction, Congress passed the bipartisan Family Smoking Prevention and Tobacco Control Act in 2009, empowering the FDA to establish comprehensive approaches to reducing tobacco-related harm. However, the senators assert that the CTP has routinely failed to meet the Act's requirements, particularly in making timely application determinations.

To date, the CTP has authorized fewer than 50 out of over 26 million premarket tobacco product applications (PMTAs) and only 16 Modified Risk Tobacco Products (MRTPs). This authorization rate is not in line with the CTP's own policy recognizing the continuum of risk in tobacco products. The availability of scientifically substantiated harm-reduced products could potentially have a significant impact on improving public health outcomes for smokers.

Despite an increase in staffing levels and significant financial resources, the CTP has struggled to keep up with its responsibilities. The independent Reagan Udall Foundation (RUF) conducted a review of the CTP in December 2022, concluding that the agency needs to develop a clearer and more predictable framework for PMTA and MRTP application submission and reviews. In light of these findings, the senators have posed several questions to Dr. Califf and the FDA, seeking clarification on the CTP's review process, prioritization strategies, and efforts to expedite decision-making.

The senators are also interested in understanding whether the CTP has considered integrating concepts such as accelerated reviews or supplemental PMTA pathways into its review program for tobacco products. Additionally, they are keen to know what steps the agency is taking to raise public awareness about the differences in risk between product categories and to encourage smokers to switch to less harmful alternatives.

In their letter, the senators have requested a response from the FDA within 30 days, emphasizing the importance of addressing these questions and concerns. By urging the FDA to reform its application review process for harm-reduced products, Senators Paul, Manchin, and Budd are taking a significant step toward prioritizing public health and promoting evidence-based decision-making in tobacco regulation.