Claire and Present Danger

Senator Claire McCaskill (D, MO) thinks that the FDA’s draft guidance on off-label communications is "a startling potential change in policy.”

Um, no.

Someone should point out to the Senator that the “policy” that counts here is the First Amendment -- and there’s no question that it applies to commercial free speech. Judge Royce Lamberth (US District Court in DC) unambiguously ruled that restriction of off-label information, especially peer-reviewed journals, violates the First Amendment.

So much for the “startling change of policy.” (Was the Senator not briefed on this issue before she made her pronouncement? Sloppy staff work.)

Or, to quote Stephen Mahinka (veteran health care attorney and partner at Morgan Lewis), for the Senator (and her best pal Jerry Avorn) to imply a “startling change” is "intellectually dishonest or evidence that they are ignorant of the legal context.”

Ouch.