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Executive Summary

SANDOZ' PARLODEL: FDA's PROPOSED WITHDRAWAL OF LACTATION PREVENTION claim is not based on the law's requirement for new safety or efficacy information, the company maintained in an April 23 petition opposing withdrawal of the indication. Sandoz argues that, because the approval of the Parlodel lactation claim was based on "adequate and well controlled studies" and a "favorable benefit/risk determination," FDA's determination of an "unacceptable benefit/risk ratio must be based on new scientific evidence, or an objectively determined change in circumstance (e.g. a new safety or efficacy concern or a safer drug approved for the same indication)." FDA, Sandoz contended, should not rely on the "opinion of a small group of doctors [FDA's advisory committee] that there is no need for the indication to be treated." FDA asked Sandoz to voluntarily withdraw the postpartum lactation prevention indication in July after its Fertility and Maternal Health Advisory Committee recommended the action at its June 1 and 2 meeting ("The Pink Sheet" June 5, T&G-11). The committee, which one year earlier had recommended that Parlodel (bromocriptine mesylate) remain available for the indication, reasoned that any potential risks of therapy were not justified by the limited need to treat the temporary condition. The committee also recommended that the indication be deleted from sex hormone products currently labeled for prevention of postpartum lactation. FDA has not yet issued a formal notice to withdraw the claim. Following the agency's request for a voluntary withdrawal, Sandoz reps met with FDA in September to argue against withdrawing the claim. The firm was recently notified that Acting Commissioner Benson concurs with the Fertility and Maternal Health Division's view that the indication should be withdrawn. In addition to the legal argument that perceived need is not a basis for NDA withdrawal, the petition maintains that the committee's conclusion "that there is no need for drugs for this not based on any adequate and well-controlled studies or survey of medical opinion, but rather on the subjective views of the committee members." The petition notes that the only new data reviewed by the committee at its second meeting was an unpublished retrospective study on the incidence of breast pain and engorgement in 209 women hospitalized for more than two days. Sandoz criticized the study for several deficiencies, including its short duration; the company maintained that "pain and congestion peak between three and five days, so it is likely that the charts reviewed did not cover most patients during that period." Sandoz pointed out that the advisory committee had not reviewed a recently published study on bromocriptine or other literature studies supporting the need for the product and its efficacy. Part of the reason for the second advisory committee meeting was to review final results from an epidemiologic study on safety that was in progress during the 1988 meeting. The study, conducted for Sandoz by Epidemiologic Resources Inc., examined the association between Parlodel and seizures. The EIR study found that overall, Parlodel users were actually at 22% lower risk of seizures than women not treated with the drug. However, the study also found that a certain subgroup with seizures occurring 72 hours after delivery was at a 66% higher risk. The petition reiterates Sandoz' position at the advisory committee meeting that additional labeling changes and educational programs can address the concerns of FDA and the advisory committee. The firm proposes to prepare a patient information booklet discussing the benefits of breastfeeding and to modify labeling to make clear that the drug is indicated "1) after stillbirth or abortion; 2) after parturition when there exists a contraindication to breastfeeding or medical condition in the mother or child that makes breastfeeding undesirable; or 3) when a mother elects not to breastfeed and not to avail herself of alternative supportive therapy." Sandoz' petition was prepared by the D.C. law firm Kleinfeld, Kaplan & Becker.

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