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.
Gottlieb is focused on the need to increase competition in the marketplace to address drug prices. He states: “We know that enabling more generic competition, where Congress intended, helps reduce prices, enables more access, and improves public health.” This is true, however, in referencing Congress’ intent, the floodgates are open to interpretation and scrutiny. First, generic drugs may be the focus of Gottlieb’s efforts, but it’s more often brand-name drugs that are out of reach due to prices. Applying his reasoning, this would have to cover brand-name drugs as well: more competition leads to better public health outcomes.
Current law too often impedes such robust competition, regardless of Congress’ intent.
Congress banned drug reimportation in 1988, except by drug companies reimporting their own products for sale in the United States. Congress’ intent in banning reimportation is usually described as an effort to prevent substandard or counterfeit drugs being brought into the country as “American Goods Returned” from reaching U.S. pharmacy shelves. The Congressional Record does not show that Congress intended to stop individuals from buying lower-cost, FDA-approved drugs from Canada for their own use. So, should they be allowed to do so? The FDA, via executive authority, could expressly permit it.
The FDA is on board with the undeniable: that high drug prices impede access and hurt patients. Its role in public health protection must heed the call of that reality by expressly allowing Americans to buy lower-cost medication from Canada.Tagged with: FDA, FDA Commissioner, Gottlieb