FDA hindrance to life-saving tech

The Food and Drug Administration is hardly a flashy agency. News releases about drug approvals and genetic testing don’t get quite as much fanfare as NASA’s latest mission or the Pentagon’s latest maneuver.

But the FDA’s role as a gatekeeper of innovation has increased significantly over the past few decades, with billions of lives sitting on the sidelines.

Now, with a rash of decisions awaiting the guidance of agency officials, New Mexicans have a lot to gain with prudent FDA decision-making that prioritizes customer choice over bureaucratic meddling.

The Land of Enchantment enjoys some of the highest sun exposure levels in the continental United States, but this pleasant weather presents a double-edged sword. Melanoma incidence in the state is higher than the United States average, and the genetic component of the disease makes it all-too-easy for many to develop a malignancy.

Personal genetic testing services like 23andMe have been able to point to some of the genetic variants that increase melanoma risk, pointing last year to the suppression of a gene known as BASP1.

Unfortunately, 23andMe and other retail testing services have been stymied by the FDA’s unwillingness to allow health-related conjectures in commercial genetics reports. In April, the agency took the encouraging step of allowing testing companies to identify the probabilities of 10 diseases for which there is well-documented genetic evidence on, including late-stage Alzheimer’s disease and Parkinson’s disease. But the continuing FDA ban on profiling for many deadly diseases, including melanoma, keeps customers in sunny states in the dark.

In addition to genetic testing, the FDA will likely weigh the impact of “heat-not-burn” tobacco products this year. To the nearly 20 percent of New Mexicans who smoke cigarettes, products that offer a genuine smoking experience without the harm of actual smoking offer a safe exit ramp from a destructive habit. The FDA is currently considering an application for heat-not-burn products to be approved for sale in the US as a “modified risk tobacco product,” which would permit it be sold in a way that communicates to adult smokers that it offers reduced risk or reduced exposure to harmful compounds compared to traditional cigarettes.

FDA is reviewing the application, consulting with the Tobacco Products Scientific Advisory Committee.

But in the face of clear scientific evidence in favor of this reduced risk products, slow-walking deliberation will mean less lives saved. Research into the safety of heat-not-burn clearly shows lower health risks than ordinary smoking.

Three years ago, a research team led by Dr. Reto Auer of the University of Bern in Switzerland examined the level of carcinogens emitted from a heat-not-burn puff, compared to the traditional cigarette brand Lucky Strike. The team found that amounts of polycyclic aromatic hydrocarbons (PAH) found in smoke from the new product were far lower than for cigarette smoke.

To Dr. Auer, however, “there is no safe minimum limit for some of the chemicals” and therefore more research is needed before the mass-introduction of the product.

The “zero acceptable risk” camp, however, puts all practicality to the wayside at a considerable cost. The idea of risk reduction through a gradual decrease in exposure is a time-tested way to minimize public health harms, in areas ranging from weight loss to gambling control. The logic of heat-not-burn is similar to the dietary approach advised by medical organizations, which emphasize gradually transitioning to healthier foods rather than cutting out all fatty foods right away.

Vaping products currently try to serve that purpose, but many smokers report that vapes are simply too unlike cigarettes to be used in a realistic transition.

This destructive, risk-adverse thinking is unfortunately pervasive at the FDA, and keeps life-saving technologies off the shelves. By adopting a more permissive attitude toward retail genetic testing and heat-not-burn products, the agency can show that it values customer choice and safety.

With more effective federal policymaking, New Mexico can be a better place to live, with more careful sun exposure and tobacco consumption.

Paul Gessing is president of New Mexico’s Rio Grande Foundation, which promotes limited government, economic freedom and individual responsibility. Contact him at: [email protected]