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Executive Summary

BERKOVITZ VS. U.S.: "THERE IS NO REASON TO BELIEVE" that the Supreme Court decision will impact on drug approval decisions, FDA Associate Chief Counsel Ann Wion, PhD, said at the Food & Drug Law Institute's 32nd Annual Education Conference held Nov. 29-30. "In federal court tort claims act actions brought against the government in connection with FDA drug product approvals, the courts have uniformly dismissed the suits as barred by the discretionary function exception. There is no reason to believe that the Berkovitz decision would necessarily change that usual outcome for drug safety cases brought against the government," Wion stated. One reasonable implication from the Berkovitz opinion, Wion said, "may be that agency officials wishing to minimize the government's exposure to tort liability should not establish detailed regulatory criteria and regulations." She noted that the detail in FDA's polio vaccine regulations partly reflects implementations of the Public Health Service Act licensing provisions, which involved arranging specific product standards and regulations. Wion pointed out that FDA does not have product specific regulations for products approved under NDAs; instead the agency has promulgated regulations describing general information for applications and general criteria for acceptable studies. The Supreme Court Berkovitz case involved allegations that FDA knowingly released one lot of Lederle's Orimmune oral polio vaccine in 1979 without conducting the mandated virulence testing. The June 13 court ruling found that the discretionary function exception to tort liability would not protect FDA from personal injury claims "when a suit charges an agency with failing to act in accord with a specific mandatory directive" ("The Pink Sheet" June 20, T&G-4). The discretionary function exception, Wion explained, will not block suits based on two types of claims: "First, a claim that the product was approved without a determination of compliance. Second, a claim that the product was approved even though the agency determined that it did not comply with regulatory standards." Wion noted that "regulations that have the force and effect of law are also often more readily enforceable by agencies than standards developed less formally." Another implication that can be drawn from the Berkovitz decision, she offered, "is that to protect against governmental tort liability at a minimum, regulations setting approval requirements should contain waiver provisions to be invoked by the agencies at their discretion." The FDA attorney pointed out that currently there are six polio vaccine cases, including the Berkovitz case, pending against the government in federal district courts. She added that the combined total of damages requested in the six suits exceeds $40 mil. "These cases have been consolidated for the discovery or pretrial phase of the litigation during which the facts about the licensing and lot release of Lederle's Orimmune will be gathered," Wion said. She noted that the discretionary function exception issues "will undoubtedly be revisited for these pending cases."

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