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What FDA Commissioner Gottlieb’s Mission on Drug Prices Says about Importation

FDA Commissioner Scott Gottlieb, MD

This week, FDA Commissioner Scott Gottlieb said something revolutionary about the role of the FDA. For many years, the agency has maintained that its sole focus when it comes to regulating drugs is to ensure their safety and efficacy, but that drug prices are beyond its purview. In remarks pertaining to the FDA’s new initiative to speed up generic drug approvals of complex  pharmaceuticals, Gottlieb stated that “if consumers are priced out of the drugs they need, that’s a public health concern that FDA should address.”

To those who support safe importation of lower-cost medications, that statement was the shot heard around the world. Indeed, drug prices are a public health concern. If we’re using logic, reason, and commonsense, it becomes untenable from a public policy and health perspective, grounded in basic medical ethics, to prohibit or even discourage importation of lawfully-manufactured medication by individuals who can’t afford it locally. (more…)

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