Bowling Green Today

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), calling for reform of the application review process for harm-reduced products. The Senators also requested information about the FDA Center for Tobacco Products' (CTP) policies and actions to ensure efficient and science-based decision-making.

In their letter, the Senators highlighted the importance of harm reduction in addressing the public health impact of cigarette smoking, which remains the leading cause of preventable disease and death in the United States. They noted that the availability of harm reduction alternatives has contributed to the decline in combustible cigarette smoking.

However, the Senators expressed concern that the CTP's application review process has been slow and inefficient. They pointed out that since 2009, the CTP has received over 26 million premarket tobacco product applications (PMTAs), but has authorized fewer than 50. The authorization rate for Modified Risk Tobacco Products (MRTPs) is even lower, with only 16 authorized for four unique products and their accessories. This low authorization rate is not in line with the CTP's recognition that tobacco products fall on a continuum of risk.

The Senators questioned the reasons behind the CTP's backlog, particularly considering the significant increase in staff and the authority to collect user fees from tobacco manufacturers and importers. They referred to a review by the independent Reagan Udall Foundation (RUF), which recommended that the CTP develop a clearer and more predictable framework for PMTA and MRTP application submission and reviews.

In their letter, the Senators posed several questions to Dr. Califf, seeking clarification on the CTP's prioritization process for PMTAs and MRTPAs, the consideration of accelerated review programs, the support for a supplemental PMTA process, and the agency's efforts to raise public awareness about the relative risks of different tobacco product categories. They also inquired about the specific scientific criteria used by the CTP to determine the potential public health impact of a PMTA product and whether the agency applies any criteria to provide applicants an opportunity to address application deficiencies before issuing a Refuse to Accept (RTA) decision.

Additionally, the Senators referenced an article from the Society for Research on Nicotine and Tobacco, which called on the FDA to establish a definition for premium cigars. They asked whether the FDA agrees with this approach and whether a separate category for premium cigars could promote risk-appropriate research and regulation.

The Senators requested a response from Dr. Califf within 30 days of the letter's date.

The FDA and CTP have yet to respond to the Senators' letter, but their call for reform in the review process for harm-reduced products underscores the importance of efficient and science-based decision-making to improve public health outcomes.