The drug manufacturer Allergan is taking the Food and Drug Administration to court.
The FDA has ordered Allergan to violate the FDA’s own rules against disseminating information about “off-label” uses of a drug, uses that may be medically common but which, unlike “on-label” uses, were not specifically certified as safe and effective during the FDA’s approval process.
Once a drug has been approved, doctors may legally prescribe the drug for safe off-label uses.
The FDA now wants Allergan to send detailed safety information to physicians about both off-label and on-label uses of Botox®. Yet the FDA bans promoting drugs for off-label uses. A company may convey truthful information about such uses in only very restricted ways.
Companies have paid through the nose for violating these restrictions. In 2009, Pfizer had to pay $2.3 billion for promoting off-label uses of its drugs. Another $1.4 billion was looted from Eli Lilly for the same “crime.”
Allergan is understandably reluctant to obey a government agency’s edict to disobey other edicts promulgated by that same agency — especially when the price of disobedience can be so high. Better to solicit some judicial clarity.
Better, certainly, than following orders and hoping for the best.
Will the court vindicate and enforce constitutional protections for freedom of speech in the realm of pharmaceuticals? Such a ruling would unshackle drug companies from ludicrous hindrance, freeing them to speak.
And it would help doctors and patients.
This is Common Sense. I’m Paul Jacob.