FDA marketing v. First Amendment: Washington Legal Foundation legal challenges to off-label policies may force unprecedented changes at FDA.
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The plaintiffs were family planning (FP) services and physicians who sought a preliminary injunction against enforcement of regulations promulgated by the Secretary of Health and Human Services of the US. The regulations prohibited counseling and referral for abortion services by FP services that receive funds under Title X of the Public Health Services Act. The Court held that the regulations exceeded the Secretary's authority, since nothing in Title X or legislative history relating to its enactment indicated that Congress intended to prohibit FP services from offering information with respect to abortions. The Court also ruled that the regulations violated a woman's Fifth Amendment liberty interest in choosing to have an abortion, her First Amendment right to receive necessary information to exercise her liberty interest, and a physician's First Amendment right to disseminate necessary information to patients. The Court granted the request for a preliminary injunction. On 15 June 1988, the same court granted the plaintiffs' request for a permanent injunction against enforcement of the regulations. On 3 March 1988, the US District Court, D. Massachusetts, also enjoined enforcement of the regulations (Commonwealth of Massachusetts vs. Bowen [679 F.Supp. 137]). On 30 June 1988, however, the US District Court, S.D. New York, rejected a challenge to the regulations, ruling that the Secretary did not exceed his authority and that the regulations were not unconstitutional (State of New York vs. Bowen [690 F.Supp. 1261]).