This week, FDA Commissioner Scott Gottlieb announced that inspections by drug regulatory authorities of foreign manufacturing plants that export pharmaceuticals to the U.S. are sufficient to ensure the integrity of those products: meaning the FDA doesn’t also need to inspect them. The countries identified are Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the United Kingdom. All are currently members of the European Union (the UK is soon Brexiting).
Although this has made headlines as an unprecedented practice, the FDA relying on inspections from foreign regulators is not an entirely new development. The FDA does not inspect all foreign plants that export medicine to the U.S. even though most pharmaceuticals sold in the U.S. are foreign-made.
So what’s with the big announcement then?
Tagged with: FDA Commissioner, foreign made, Scott Gottlieb
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…)
Tagged with: FDA, FDA Commissioner, Gottlieb