On Feb. 24, the Wall Street Journal’s editorial board published a piece titled, “Who’s in charge of the FDA?” arguing that internal tensions at the U.S. Food and Drug Administration could be undermining efforts across all departments. The piece points to decisions affecting emerging products and suggests a broader debate within the FDA over how flexible the approval process should be.
In response, Matthew R. Holman, vice president of U.S. Scientific Engagement & Regulatory Strategy at Philip Morris International and a former chief scientist at the FDA’s Center for Tobacco Products, wrote a letter that the WSJ published yesterday (March 5), saying that despite criticism and organizational challenges facing the FDA, the organization — and the CTP in particular — has shown notable improvement.
“Over the past year, the FDA’s Center for Tobacco Products has become a notable bright spot — delivering real results for an agency working through significant institutional challenges,” he wrote. “The CTP has been responsive to industry experts and congressional leaders.”
Responding to concerns raised in a 2022 Reagan-Udall Foundation report and congressional hearings about transparency and a backlog of smoke-free product applications, Holman said the center has become more receptive to industry and lawmakers, pointing to actions such as a pilot program to fast-track nicotine pouch reviews and upcoming advisory committee hearings on smoke-free products.
“The CTP has taken several notable actions in the past year and is poised for more positive developments,” Holman wrote. “There’s still more work to be done to ensure the CTP is meeting its mission and properly regulating tobacco products in the marketplace with a focus on authorizing scientifically substantiated smoke-free products. But the progress we have seen in the first year of this administration is notable.”
