The situation with off-label promotion would be seen as absurd if applied outside the pharmaceutical industry. Consider this scenario: Imagine that a government agency agreed that Ford’s 4×4 pickups performed well as work trucks and gave Ford permission to promote the trucks to carpenters, brick layers and electricians. Later, some astute Ford customers realized that they could use these trucks for camping and fishing trips. Sales for this use grew until it was a sizable proportion of total sales. Ford, however, couldn’t advertise its trucks for camping and fishing. And, if a customer specifically asked about such an application, Ford couldn’t answer the question directly–lest it violate government rules–and instead mailed third-party literature to the customer. Does this help Ford sell pickups? No. Does this help campers and fishermen who want passage into the back-country? No. Does this support the First Amendment’s protection of free speech? No. The only entity that it helps is the government agency that brazenly says that its rules supersede the Constitution.
Drug safety is important, but the FDA is fundamentally unable to balance lives lost to bad drugs with lives lost to good drugs not being used due to FDA policies.
Will this $2.3 billion dollar fine encourage innovation? Will it save lives? The obvious answer is no.
For more on how the FDA costs health care consumers money and lives see FDA Review.