Conflicts Between Government Regulation of Off-Label Communications and The First Amendment
The FDA takes the position that a drug manufacturer may not promote its drug for an unapproved use, and that any such promotion is false and misleading simply because it is not FDA-approved. However, many off-label uses are in fact effective and safe, as is evidenced by subsequent FDA approval of such uses for numerous drug products. The Supreme Court has in recent terms begun to address the boundaries between government regulation of pharmaceuticals and the First Amendment free speech guarantee. Some legal observers have suggested that the trend in the Court's decisions may ultimately reduce the ability of FDA to prevent broader dissemination of off-label information about approved drug products.
Read more about this topic: Off-label Use
Famous quotes containing the words conflicts between, conflicts, government, regulation and/or amendment:
“Not all conflicts between siblings are good, of course. A child who is repeatedly humiliated or made to feel insignificant by a brother or sister is learning little except humiliation and shame.”
—Lawrence Kutner (20th century)
“The two most far-reaching critical theories at the beginning of the latest phase of industrial society were those of Marx and Freud. Marx showed the moving powers and the conflicts in the social-historical process. Freud aimed at the critical uncovering of the inner conflicts. Both worked for the liberation of man, even though Marx’s concept was more comprehensive and less time-bound than Freud’s.”
—Erich Fromm (1900–1980)
“In framing a government which is to be administered by men over men ... you must first enable the government to control the governed; and in the next place oblige it to control itself.”
—James Madison (1751–1836)
“Nothing changes my twenty-six years in the military. I continue to love it and everything it stands for and everything I was able to accomplish in it. To put up a wall against the military because of one regulation would be doing the same thing that the regulation does in terms of negating people.”
—Margarethe Cammermeyer (b. 1942)
“The First Amendment is not a blanket freedom-of-information act. The constitutional newsgathering freedom means the media can go where the public can, but enjoys no superior right of access.”
—George F. Will (b. 1934)