Opinion ID: 2516122
Heading Depth: 1
Heading Rank: 3

Heading: The FDA Report

Text: Plaintiffs' claim was presented in the context of a decade-long disagreement between Sandoz and the Food and Drug Administration (FDA) concerning the use of Parlodel for the prevention of physiologic lactation. (Parlodel's generic name is bromocriptine.) The FDA originally approved the use in 1980. By 1983, however, both Sandoz and the FDA began receiving reports relating the drug to hypertension or related effects. As a result of these reports, FDA staff members requested in both May 1983 and March 1985, that Sandoz place a warning of the adverse experiences in its labeling. Initially, Sandoz would not agree to place the requested warning. In February 1987, however, Sandoz agreed to both make the requested labeling changes and to send a letter to doctors alerting them to the potential hazards of using Parlodel for the prevention of lactation. The FDA continued to receive reports over the next few years of negative side effects associated with the use of Parlodel for the prevention of lactation. The FDA's Fertility and Maternal Health Drugs Advisory Committee considered a comprehensive study by Sandoz on the drug (the ERI study) that downplayed the relationship between Parlodel and the asserted harms. However, the FDA determined that the ERI study: (1) failed to allay concerns regarding the drug's association with seizures and (2) was too small in size to adequately characterize the risk of stroke. The FDA committee recommended that drugs (including Parlodel) not be used for lactation suppression. The possibility that the products might cause serious adverse experiences in some patients outweighed the limited benefits associated with their use. The FDA agreed with its committee's recommendation and asked that all manufacturers remove the indication for lactation suppression from their drug products. The FDA met with Sandoz on June 2, 1989, and informally requested a voluntary withdrawal of the lactation suppression indication from Parlodel's labeling. Sandoz declined. Sandoz met again with the FDA on September 7, 1989, to discuss alternatives to withdrawal of the indication. The FDA issued a letter on September 13, 1989, that reaffirmed its original withdrawal request. On October 25, 1989, Sandoz declined the FDA request for withdrawal and announced its position that Parlodel should not be used routinely but should remain available for specific circumstances under which the physician and the patient decide that the drug is indicated. On March 2, 1990, the FDA advised Sandoz that attempts to gain approval for revised package inserts and a draft patient brochure were not approvable. The FDA had not changed its opinion that there is no need for pharmacologic agents to prevent postpartum lactation. On August 17, 1994, the FDA issued a talk paper stating that it had initiated procedures for withdrawing approval for the indication. A day later, Sandoz withdrew the Parlodel indication for the prevention of lactation in the United States.