Bowling Green Today

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 letter also requests information about the CTP's policies and actions to ensure it is acting efficiently and based on science and evidence.

The Senators highlight the importance of harm reduction in combating the leading cause of preventable disease and death in the United States - cigarette smoking. They point out that less than eight percent of smokers successfully quit smoking each year, while thousands start smoking every day. The availability of harm reduction alternatives has contributed to the decline in combustible cigarette smoking.

In 2009, Congress passed the bipartisan Family Smoking Prevention and Tobacco Control Act, which tasked the FDA with establishing a comprehensive approach to tobacco harm reduction. However, the Senators express concern that the CTP has routinely failed to meet the Act's requirement to make application determinations within 180 days.

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. The Senators argue that this authorization rate is not in line with the CTP's acknowledgment that tobacco products fall on a continuum of risk. They believe that the availability of scientifically substantiated harm-reduced products could potentially improve health outcomes for smokers.

Despite staffing increases and significant user fees collected from tobacco manufacturers and importers, the CTP continues to struggle with backlog. The Senators reference a review by the independent Reagan Udall Foundation (RUF) that recommends the CTP develop a clearer and more predictable framework for application submission and reviews.

In their letter, the Senators pose several questions to Dr. Califf and the FDA, including whether the agency prioritizes the review of PMTAs or MRTPAs and if there should be a prioritization strategy. They also inquire about the CTP's consideration of integrating accelerated review programs for tobacco products and its support for a supplemental PMTA process.

The Senators also ask about the CTP's efforts to raise public awareness of the difference in risk between product categories and to encourage smokers to switch to less harmful alternatives. They seek clarification on the scientific criteria used by the CTP to determine if a product is appropriate for the protection of public health and whether applicants are given an opportunity to address application deficiencies before receiving a Refuse to Accept (RTA) decision.

Lastly, the Senators inquire about the FDA's stance on setting a definition for premium cigars and establishing a separate category for them to promote risk-appropriate research and regulation.

The Senators request a response to their questions within 30 days of the date of the letter.

This letter underscores the Senators' commitment to promoting harm reduction and ensuring that the FDA's review process for harm-reduced products is efficient and evidence-based. Their efforts align with the goal of reducing the harm caused by cigarette smoking and providing smokers with safer alternatives.

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/