Technological advances touch every aspect of our lives, often in ways we rarely think about.
Technological advances touch every aspect of our lives, often in ways we rarely think about. Today, we live longer, healthier, and better lives because of our access to innovative products that were unimaginable in the recent past.
That’s why it’s critical for regulators to make timely and common-sense decisions. Yet excessive risk-aversion is endemic at federal agencies.
The Food and Drug Administration (FDA) is one of the worst offenders. The agency regulates products that account for more than a trillion dollars annually. The FDA’s obsessive dislike for taking on reasonable risk often comes at the cost of creating unreasonable harm. But the agency is rarely held to account for its inaction.
Following the Obama administration’s record-setting number of regulations, there was hope that the new administration would keep its promise to unshackle businesses, large and small, to develop life-improving products and create American jobs.
In addition to enacting new regulations, the agency frequently stymies progress under existing rules.
Under President Obama, the FDA refused to grant pre-market review to a direct to consumer suite of tests by 23andMe, which would have allowed consumers to test whether they were at increased risk of being diagnosed with diseases such as Parkinson’s and Celiac. In doing so, it denied affordable access to information that, in the case of Parkinson’s, could have led those who were genetically predisposed to seek medical advice in the critical early stages of disease, when treatment could slow the progression of the disease.
In the case of Celiac, patients commonly suffer from crippling symptoms for months or years before making difficult but important dietary changes.
Fortunately, Commissioner Scott Gottlieb’s FDA slightly loosened the rules on genetic testing, but testing companies are still unable to warn patients of the vast majority of diseases out there.
Tobacco Harm Reduction
The agency’s track record is even more troubling when it comes to approving beneficial innovations that could help cigarette smokers quit. The FDA must quickly keep its more than year-old promise “to issue foundational rules to make the product review process more efficient, predictable, and transparent for manufacturers while upholding the agency’s public health mission.”
Earlier this month, Commissioner Gottlieb reiterated the need to minimize, “addiction to the most harmful products while encouraging innovation in those products that could provide adult smokers access to nicotine without the harmful consequences of combustion.”
Innovative alternatives are critical to public health, especially given that FDA approved nicotine replacement therapies and other currently available medications haven’t done the trick for the approximately 15 percent of American adults who still smoke.
In March of 2017, Philip Morris International (PMI) submitted a pre-marketing tobacco application (PMTA) to the FDA for IQOS, which heats rather than burns tobacco.
Agency-watchers expected the FDA to approve the PMTA by this February, consistent with both the Tobacco Control Act and the agency’s own guidelines. Yet to this day, PMI’s PMTA is gathering dust and seems lost in the process. The approval process for other reduced-risk tobacco product applications drags on with little outward signs of movement.
In Japan, one of a number of countries where IQOS is sold, the non-combustible tobacco product quickly captured 10 percent of the tobacco market, according to the Washington Post. IQOS seems to deliver exactly what many current smokers want (satisfaction and potentially less harm), and what the FDA has already been calling for (nicotine without combustion).
So, why the delays? FDA, in response to our written query, says it does not comment on pending applications, but that generally, the agency reviews an application as required by law.
An FDA spokesman also told us that, “In the meantime, for smokers who do want to quit, there are proven, FDA-approved smoking cessation prescription medicines, as well as over-the-counter nicotine replacement therapy (NRT) products, such as skin patches, lozenges and gum, to help in the quitting process.”
In other words, despite the agency’s lofty comments about the need for innovation to help smokers who haven’t been able to quit with the help of currently-available FDA-approved medicinal products, there are always FDA-approved medicinal products. As the saying goes, “Insanity is doing the same thing over and over again, but expecting different results.”
In his 100-day action plan, President Trump singled out the slow-moving FDA, promising reforms that “will also include cutting the red tape at the FDA.” The administration must now decide whether to continue to embrace innovation or return to the slow “business-as-usual” model stymieing scientific advances that can save countless lives.