Bowling Green Today

WASHINGTON, D.C. - In a joint effort, U.S. 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 also requested information about CTP's policies and actions to ensure it is acting efficiently and based on science and evidence.

In the letter addressed to Dr. Califf, the senators highlighted the public health impact of cigarette smoking in the United States and the importance of harm reduction alternatives. They noted that cigarette smoking is the leading cause of preventable disease and death in the country, with nearly 31 million Americans still smoking. However, the availability of harm reduction alternatives has contributed to a decline in combustible cigarette smoking.

The senators emphasized the role of the FDA in establishing a comprehensive approach to tobacco harm reduction through the bipartisan Family Smoking Prevention and Tobacco Control Act of 2009. They pointed out that the Act requires the CTP to make application determinations within 180 days, but the agency consistently fails to meet this requirement.

According to the senators, since 2009, over 26 million premarket tobacco product applications (PMTAs) have been submitted for new tobacco products in the U.S., but the CTP has authorized fewer than 50. Furthermore, the CTP has only authorized a total of 16 Modified Risk Tobacco Products (MRTPs) for four unique products and their accessories. The senators believe that this low authorization rate does not align with the CTP's acknowledgment that tobacco products fall on a continuum of risk.

The senators also expressed concern about the CTP's backlog and staffing shortages. They highlighted that while the CTP's staff has more than doubled over the past decade, the agency still struggles to meet its requirements. The senators noted that the FDA has the authority to assess and collect user fees from tobacco manufacturers and importers, amounting to $712 million annually since 2019, providing significant resources for the CTP.

To address these issues, the senators referred to a December 2022 review of the CTP by the independent Reagan Udall Foundation (RUF). The RUF recommended that the CTP develop a clear and predictable framework for high-quality PMTA and MRTP application submission and reviews. In light of these recommendations, the senators posed several questions to Dr. Califf, including whether the agency prioritizes the review of PMTAs or MRTPAs, whether there should be a prioritization strategy, and whether the CTP has considered integrating accelerated review programs for tobacco products.

The senators also inquired about the CTP's support for a supplemental PMTA process, its efforts to raise public awareness about the difference in risk between product categories, and the specific scientific criteria considered in the assessment of a product's potential to promote complete switching or a significant reduction in combustible cigarette use.

In addition, the senators asked whether the CTP applies any criteria to determine whether applicants have the opportunity to address application deficiencies before receiving a Refuse to Accept (RTA) decision. They also referred to an article from the Society for Research on Nicotine and Tobacco that called on the FDA to set a definition for premium cigars, seeking the FDA's stance on establishing a separate category for premium cigars to promote risk-appropriate research and regulation.

The senators requested a response from Dr. Califf within 30 days of the date of the letter, emphasizing the importance of these questions.

This bipartisan effort by Senators Rand Paul, Joe Manchin, and Ted Budd demonstrates their commitment to ensuring that the FDA's application review process for harm-reduced products is based on science, evidence, and efficiency. By urging the CTP to reform its procedures and seeking information about its policies, the senators aim to improve public health outcomes and provide smokers with safer alternatives.

To find out more, go to this link: https://www.paul.senate.gov/senators-paul-manchin-budd-send-letter-to-fda-urging-ctp-reform-for-harm-reduced-products/