Prioritizing the Biggest Threat to Public Health: How the FDA’s New Voucher Program Can Help Make Cigarettes Obsolete

This week, FDA Commissioner Makary announced a new National Priority Voucher program that drug developers can use to shorten the FDA’s review time for specific applications from the usual 10 - 12 months to an expedited 1 - 2 months.

The idea has enormous potential. As Commissioner Makary describes it, the concept is to enable drug makers to pick their highest-priority drugs - the ones that have a real chance to significantly improve public health and save lives - and put them on a special review track in which experts from across FDA offices will convene as a multidisciplinary team to review the application.

Program participants will be able to submit preliminary data while their trials are ongoing and have more direct interactions with their reviewers to resolve any issues that may arise over the course of the trial. Once final trial data are submitted, the application will be reviewed in a manner that Makary analogizes to a “tumor board” in which care teams for cancer patients come together to inform “life and death questions for patients.” Done right, this model will not only speed up the review process, but it may also lead to better decisions. Rather than having teams working in silos, the “tumor board style” review will ensure a real-time integrated dialogue based on the latest science.

My hope is that Commissioner Makary will not limit this tradition-busting approach to drug reviews. Because, as he well knows, one of the biggest single threats to human life and health in the United States today remains the combustible cigarette, which his agency also regulates.

The Tobacco Control Act established a Premarket Tobacco Product Application (PMTA) process to incentivize the private sector to develop novel nicotine products that would be “appropriate for the protection of public health.” Specifically, manufacturers would need to demonstrate to the agency through this pathway that their products under review would be less harmful to health than combustible cigarettes; would be effective at helping adults who smoke to switch completely away from cigarettes; and could be marketed without undue risk of initiating non-smokers, especially those underage.

As I have written about before in these pages, the current review process is not working as intended. To date, the FDA has only authorized a small handful of vapor products, which collectively represent a tiny fraction of the market. The costs of this backlog have been borne almost exclusively by the populations that the Tobacco Control Act is trying to protect: adults who smoke are left with few FDA-authorized smoke-free products, and meanwhile, youth who should not be initiating on any nicotine products are being marketed to directly by a new cohort of bad actors.

There are many reasons for the shortcomings of the PMTA process. But at a fundamental level, the issues are not dissimilar to those identified by Commissioner Makary, which he now seeks to address, at least in part, through the creation of the Voucher program. Moreover, this FDA has inherited an enormous backlog of applications for high-quality, scientifically-substantiated products that could help eliminate the death and disease caused by smoking. Addressing this backlog and seizing on the unique opportunity to make cigarettes obsolete requires truly innovative approaches to dramatically increase the throughput of PMTA authorizations.

The Voucher program may not be a silver bullet for the different process delays in the drug industry. And, indeed, time will tell how it works when it comes to traditional drug applications. But reading about it this week felt like a breath of fresh air. It feels like Commissioner Makary is truly committed to reform and to getting validated products into the hands of people that can extend, improve and even save their lives.

And his fundamental insight that we don’t need to choose between rigorous science, speedy review processes and sound public health strategy is worth quoting in full:

“The new national priority review program is designed to align speed, science and strategy. It rewards companies working on innovative solutions to real challenges faced by the American public, without sacrificing safety or the FDA’s rigorous standards.”

Now, those energizing winds of change need to reach all corners of the agency, including the Center for Tobacco Products. In doing so, Commissioner Makary can accelerate progress toward perhaps the most meaningful public health win that is within his power to deliver during the course of his tenure: moving America quickly and irreversibly toward becoming one of the world’s handful of smoke-free countries.