Coming on the heels of the Reagan-Udall Foundation report on the Center for Tobacco Products (CTP) at the Food and Drug Administration (FDA), the U.S. House of Representatives’ Committee on Oversight and Accountability has commenced an investigation into CTP’s regulation of tobacco and nicotine products. In a letter to FDA Commissioner Robert Califf, the Committee notes that CTP has failed to effectively administer its tobacco and nicotine regulations, resulting in uncertainty by compliant stakeholders and a proliferation of unsafe and unregulated products in the marketplace. The Committee has requested a variety of documents and a staff-level briefing regarding CTP’s activities.
Specifically, Committee Chairman James Comer notes the Committee’s “deep concerns that CTP’s decisions have been influenced by political concerns rather than scientific evidence.” The Committee cited a comment by one FDA staffer that “‘[i]n cases where reviews are finished and scientific decisions are made, they are also overruled by political agendas and pushed to change decisions.” This fact has been documented by CTP internal memoranda released in litigation challenging CTP decisions on premarket tobacco applications. The Committee also stated that “FDA must clearly identify and publicize what scientific criteria are necessary for a product, to include [electronic delivery system (ENDS) products] and smokeless products, to be authorized through the PMTA pathway and—where appropriate—the subsequent [modified risk tobacco product applications (MRTPs)] pathway.”
The Committee has requested the following documents:
- All FDA staff comments submitted to the Reagan-Udall Foundation in conjunction with the Operational Evaluation of Certain Components of FDA’s Tobacco Program;
- All communications between the White House, Department of Health and Human Services, and FDA, to include any office within the CTP, regarding tobacco or nicotine related policy decisions and evaluation of any application approval or denial decisions;
- All documents and communications between FDA and the Centers for Disease Control and Prevention regarding CTP policies, application decisions, educational campaigns, or communications;
- All documents and communications between FDA and public health advocacy groups regarding CTP policies, application decisions, educational campaigns, or communications;
- All documents that describe the specific analytic process FDA uses to apply the “appropriate for the protection of public health” standard; and
- All documents and communications related to FDA’s enforcement efforts to remove illegally marketed tobacco or nicotine products from retail locations.
This clearly a step in the right direction of bringing much-needed reforms at CTP. To the extent that FDA adheres to its obligations to produce the requested documents, the Committee has the opportunity to get further insight into opportunities for improvement within CTP, particularly with respect to premarket review and enforcement against unlawful products. Once the Committee receives and digests the requested information, we are anticipating a public hearing on these issues.