Bowling Green Today

WASHINGTON, D.C. - U.S. Senators Rand Paul (R-KY), Joe Manchin (D-WV), and Ted Budd (R-NC) 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 science and evidence.

Cigarette smoking is the leading cause of preventable disease and death in the United States, with nearly 31 million Americans smoking cigarettes, according to the Centers for Disease Control and Prevention (CDC). The Senators recognize the importance of harm reduction and highlight the decline in combustible cigarette smoking due to the availability of harm reduction alternatives. They reference the bipartisan Family Smoking Prevention and Tobacco Control Act of 2009, which tasked the FDA with establishing a comprehensive approach to tobacco harm reduction.

The Senators express concern that the FDA is not meeting its harm reduction goals due to a flawed authorization process. 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, only 16 Modified Risk Tobacco Products (MRTPs) have been authorized for four unique products and their accessories. The Senators argue that this low authorization rate does not align with the recognition that tobacco products fall on a continuum of risk.

The Senators also question the reasons behind the backlog in application reviews, as the CTP's staff has more than doubled over the past decade. Additionally, the FDA has been collecting user fees from tobacco manufacturers and importers, totaling $712 million annually since 2019. With these resources, the Senators argue that there is no reason for the CTP to be so far behind in meeting the Act's requirements.

A review conducted by the independent Reagan Udall Foundation (RUF) in December 2022 found that the CTP has been struggling as a regulator. The RUF recommended that the CTP develop a more clear and predictable framework for high-quality PMTA and MRTP application submission and reviews. In light of these recommendations, the Senators pose several questions to the FDA in their letter.

The Senators ask whether the FDA prioritizes the review of PMTAs or MRTPAs and what criteria the CTP applies in that prioritization process. They also inquire about the consideration of a prioritization strategy if one is not currently in place. The Senators suggest exploring the integration of accelerated review programs, similar to breakthrough designation, into the CTP's review program for tobacco products.

The Senators seek information on the CTP's support for a supplemental PMTA process and the agency's efforts to encourage its use and expedite decision-making on supplemental applications. They also inquire about the FDA's efforts to raise public awareness of the difference in risk between product categories and encourage smokers to switch to less harmful alternatives.

The Senators question the specific scientific criteria that the CTP considers in evaluating whether a PMTA product is "appropriate for the protection of public health." They also ask if the CTP applies any criteria to determine whether applicants should be given an opportunity to address application deficiencies before receiving a Refuse to Accept (RTA) decision.

Lastly, the Senators reference an article from the Society for Research on Nicotine and Tobacco that calls on the FDA to set a definition for premium cigars. They ask if the FDA agrees with this approach and establishing a separate category for premium cigars to promote risk-appropriate research and regulation.

The Senators request a response from the FDA within 30 days of the date of their letter. They emphasize the importance of these questions and look forward to the FDA's answers.

This letter from Senators Paul, Manchin, and Budd shows their concern about the FDA's application review process for harm-reduced tobacco products. They highlight the importance of harm reduction in reducing the prevalence of cigarette smoking and urge the FDA to act efficiently and based on science and evidence. The Senators raise questions about the FDA's prioritization process, the use of accelerated review programs, and the evaluation criteria for determining the protection of public health. They also inquire about the CTP's support for a supplemental PMTA process and the FDA's stance on establishing a separate category for premium cigars. The Senators expect a response from the FDA within 30 days.

Click this link to access more information: https://www.paul.senate.gov/senators-paul-manchin-budd-send-letter-to-fda-urging-ctp-reform-for-harm-reduced-products/