The FDA Should Put Science Over Politics
The change in leadership at the White House has led to other changes across Washington and across the country — from newly sworn-in judges and major steps in health-care reform aimed at increasing choice and competition to a sweeping tax bill that will lower rates and put more money back in the pockets of Americans. But the most significant area of change since President Trump took office one year ago is regulatory reform.
The new leadership at many of the executive agencies, boards, and commissions has led to a massive shift in the process for how rules and regulations are created, implemented, and rescinded. This is good news for consumers, businesses, and the economy. The fundamental problem with the Obama administration’s approach to regulation was that it relied on presupposing harm rather than the actual statistics. In many of the agencies that operated under the executive branch, deference was given to potential harm, e.g., to the environment or consumers, regardless of the likelihood that such harm would actually occur. That approach caused grave damage to the economy and increased the cost of regulations to nearly $2 trillion, according to the Competitive Enterprise Institute. Fortunately, the Trump administration is reversing course.
One example of this course correction on federal regulation is the work of the Food and Drug Administration (FDA) under the direction of Dr. Scott Gottlieb. In the short time that Dr. Gottlieb has led the FDA, he’s already begun to reverse the agency’s path to show more openness to data-driven innovation and embracing science as it relates to some of today’s greatest health-care challenges.
Because the Declaration of Independence makes clear that the fundamental role of government is to protect life, liberty, and property, conservatives recognize that there is a role for agencies such as the FDA to ensure that certain products meet basic standards. But Dr. Gottlieb also recognizes that regulators should never be in the business of preventing consumers from making their own choices about what harm reduction products they prefer or want to try. And it certainly makes no sense for government, which is supposed to help people protect their own health, to force rules and regulations that potentially harm individuals.
This brings us to an issue that will be in front of the FDA’s Tobacco Products Scientific Advisory Committee (TPSAC) this week: Modified Risk Tobacco Product (MRTP) application approval for the IQOS system, a new product that uses a “heat-not-burn” technology for tobacco consumption and has the potential to revolutionize the harm-reduction industry dominated, so far, by e-cigarettes.
IQOS uses heated tobacco, instead of vaporizing nicotine-infused liquids, offering a new choice for smokers who want to make a change in their health, habits, and daily lives. The product is new to the United States, but is becoming more recognized around the world, as 32 countries (including Japan, Australia, and some EU countries) have approved IQOS already. When we at the American Conservative Union held a Conservative Political Action Conference in in Tokyo last December, we observed a number of attendees trading in traditional cigarettes for the new and innovative IQOS system.
Since the product was first introduced in 2014 in Japan, nearly 3 million adult smokers worldwide have decided to stop smoking and use IQOS. The trends show how innovation can not only expand markets and enhance consumer choice but also benefit public health — all things that TPSAC should want to advance.
The FDA issued a directive last year outlining a planned approach to focus on new innovations in harm reduction with “foundational rules to make the product review process more efficient, predictable, and transparent for manufacturers, while upholding the agency’s public health mission.” With IQOS, TPSAC can ensure the FDA makes good on that commitment to innovation and show that they care about their mission: science. To research, develop, test, and refine a product such as IQOS requires that regulatory agencies place policy over politics. This is just the approach that Administrator Gottlieb envisions for his tenure at the FDA.
Science wasn’t always my best subject, but I know that it should be used honestly and appropriately by policymakers. TPSAC should use its time to ask the right questions about the science behind IQOS — look at the evidence for its potential to reduce harm for consumers and learn more about how and why this product was developed in the first place. We’re in relatively new territory when it comes to harm reduction. But one thing that has not changed is TPSAC’s mission: to advance and promote science, not politics.
Michi Iljazi is the Director of Government Affairs at The American Conservative Union.
