CONTINUING MEDICAL EDUCATION
through its involvement in CME seminars and symposia. 47 Applying the
test from Central Hudson Gas & Electric Corp. v. Public Service Comm’n
of New York, 48 the court found that the guidance documents violated the
First Amendment because they were not the least burdensome method of
restriction on commercial speech. 49 The court pointed out that full,
complete, and unambiguous disclosure by the manufacturer would advance
the FDA’s interest while placing a smaller burden on manufacturers. 50 The
court thus granted summary judgment and issued a permanent injunction
barring the FDA from continuing to enforce its off-label marketing policies
based on the guidance documents. 51
Under the injunction, a manufacturer was still required to disclose its
interest in the subject drug or device if it “sponsors or provides financial
support” for the CME program in which unapproved uses are referenced.
The manufacturer was also still required to disclose that the FDA had not
approved the referenced use. The court’s order, however, enjoined the FDA
from prohibiting manufacturers from suggesting content or speakers in
connection with a CME program as long as the manufacturer met two
conditions: ( 1) the manufacturer made the two disclosures, and ( 2) the
program was administered by an “independent program provider.” 52
The FDA ultimately took the position that the CME guidance did not
independently authorize it to prohibit or sanction speech. 53 Because the
FDA claimed that the guidance document was not binding on the agency,
the Court of Appeals for the District of Columbia later vacated the
47. Wash. Legal Found. v. Friedman (WLF I), 13 F. Supp. 2d 51, 54 ( D. D. C. 1998)
amended by 36 F. Supp. 2d 16 ( D. D. C. 1999) appeal dismissed, judgment vacated in part
sub nom. Wash. Legal Found. v. Henney, 202 F.3d 331 ( D. C. Cir. 2000) and amended by 36
F. Supp. 2d 418 ( D. D. C. 1999) and appeal dismissed, judgment vacated in part sub nom.
Wash. Legal Found. v. Henney, 202 F.3d 331 ( D. C. Cir. 2000).
48. 447 U.S. 557, 563 (1980) (finding that a law or regulation restricts free speech in a
commercial setting will violate the First Amendment by considering the following factors:
( 1) whether the speech at issue concerns lawful activity and is not misleading; ( 2) whether
the asserted government interest is substantial; ( 3) whether the regulation directly advances
the governmental interest asserted; and ( 4) whether it is not more extensive than is necessary
to serve that interest).
49. WLF I at 73.
50. Id. (noting that full disclosure is less restrictive on speech while also dealing more
precisely with the FDA’s concerns).
51. Id. at 74.
52. Id. at 74-75 (defining “independent program provider” as one that has ( i) has no
common ownership or other corporate affiliation with the manufacturer, engages in the
business of creating and producing CME seminars, and ( ii) is accredited by a national
accrediting organization pertinent to the topic of the seminars).
53. Wash. Legal Found. v. Henney (WLF II), 202 F.3d 331, 335 ( D. C. Cir. 2000).