How Scott Gottlieb’s ‘boring’ approach could transform the FDA

IQ2

Dr. Scott Gottlieb, confirmed earlier this week by the U.S. Senate to become the new commissioner of the Food and Drug Administration, has a pragmatic—some might even say boring—approach to public health that could revolutionize how FDA regulations can fight the consequences of addiction.

With his vision of the future of tobacco, Gottlieb takes all the fun out of the heated arguments that anti-tobacco and pro-vaping individuals engage in on a regular basis – offering a reasonable solution to the disease burden of cigarettes. In a 2013 Forbes essay, he stated:

Whatever one thinks of cigarette makers, if the industry was earnest about transitioning away from the manufacture of smoked cigarettes, and getting into the development of new products that would still satisfy peoples’ taste for nicotine (with hopefully much lower risks) there could be public health virtue. The overall incidence of smoking related disease could be sharply diminished.

He acknowledges the enormous power the FDA has in the future of public health, particularly as it relates to tobacco consumption. He even has the guts to imply that “big tobacco” could actually be an ally in solving a problem many think they created, by encouraging cigarette manufacturers to focus on safer products and the e-cigarette market.

He recognizes the emergence of e-cigarettes present a viable alternative to other smoking-cessation products and that they have the potential to contribute to a future without combustible cigarettes. During his confirmation hearings, Gottlieb stated that reduced-harm products should be available to consumers to transition off combustible cigarettes, and he has taken note of the burdensome regulations that will be put on small businesses who want to enter the e-cigarette market, under currently scheduled FDA vaping rules.

These comments suggest that he would be open to regulations that make it easier for safer products to enter the market, rather than the currently planned deeming regulations, which would require nearly all existing e-cigarette products to go through a pre-market tobacco application (PMTA) process that would cost approximately $300,000 for each combination of flavor, strength, mixture and device. In a harm-reduction model, this is important, because increased competition from small businesses in the e-cigarette market will increase innovation and production of even safer products, while decreasing the price point of products that are at least 95 percent safer than combustible cigarettes.

Furthermore, this harm-reduction approach also could be applied to the opioid epidemic, which Gottlieb has stated is the FDA’s top priority. Medication-assisted treatments—such as methadone and Suboxone—help nearly 40 percent of people with opioid-use disorders to abstain from heroin and other commonly abused opioids. Opioid antagonists—such as Narcan and Vivitrol—can be used to reverse overdoses and cut cravings. Pharmaceutical companies, both big and small, have an opportunity to improve upon medications that can be used to treat opioid addiction and its consequences. Gottlieb’s willingness to embrace a harm-reduction philosophy and his recognition that it is important to have a practical approach to expensive and time-consuming FDA regulations could further encourage small pharmaceutical companies to enter the pipeline of life-saving opioid addiction treatments.

During the confirmation process, Gottlieb received criticism for his ties to the pharmaceutical industry. But frankly, his recognition that the tobacco and pharmaceutical industries can help solve an addiction crisis that kills nearly half a million people a year is to be applauded. That level-headed vision is exactly what the FDA needs to reduce the economic and health burden of addiction in the United States.

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