Opinion ID: 1381810
Heading Depth: 3
Heading Rank: 2

Heading: Upjohn's Interactions with the FDA Regarding Hormone Replacement Therapy

Text: In 1966, Upjohn applied for FDA approval of Provera's use with estrogens for treatment of menopause. The FDA denied the application because Upjohn failed to justify the requested indication with adequate clinical data. In 1986, Upjohn submitted a supplemental application to the FDA, again seeking to expand Provera's indications for use of the drug to oppose the endometrial effects of estrogen in menopausal women receiving estrogen replacement therapy. The FDA denied the application because Upjohn failed to provide substantial evidence consisting of adequate and well-controlled studies ... that Provera will have the effect it is represented to have under the conditions of use prescribed, recommended, or suggested in its proposed labeling. Although Provera was not approved for use in treating menopausal symptoms, Upjohn advertised it as such. In 1984, the FDA called for the immediate cancellation of Provera advertisements appearing in Contemporary OB-GYN. The advertisements promoted Provera's off-label use with estrogen replacement therapy and failed to mention its indicated use, treatment for abnormal uterine bleeding. Upjohn agreed to limit its advertisements to the approved indication. Notwithstanding that agreement, the FDA found it necessary to request immediate cancellation of a similar advertisement in 1985, and another advertisement in 1990, that claimed Provera was the other half of hormone replacement therapy. In 1991, Upjohn submitted proposed promotional materials to the FDA for approval. The FDA limited the material because it was potentially misleading. The FDA reminded Upjohn of their previous discussions regarding material which suggests that Provera is indicated for use in postmenopausal replacement therapy for the prevention of endometrial hyperplasia. In 1998, Provera was finally approved for the reduction of endometrial hyperplasia in postmenopausal women who are receiving estrogen. Testimony at trial revealed that Upjohn did not conduct any breast cancer studies from 1960 until the time of trial.