Annals of Health Law - Vol 23 Issue 1

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).