The first drug manufacturer approved for a generic version of a branded drug has statutory exclusivity to market that generic drug for 180 days. The purpose of the exclusivity period is to make cheaper drugs available to the consumer. However, the Food and Drug Administration (FDA) has a policy requiring the generic drug manufacturer to sue the branded drug manufacturer to retain that market exclusivity when the branded drug patent holder has the patent(s) removed from the FDA's "Approved Drug Products with Therapeutic Equivalence Evaluations," also known as the Orange book. This paper discusses the effects of delisting a drug patent, and whether the FDA's policy is a valid one or contrary to the intent of statutory language.
Since last year, when generic drug makers won a victory on the issue of federal preemption before the U.S. Supreme Court, lower courts have been dismissing cases against generic drug makers left and right. But last week a federal appeals court issued a ruling that gives plaintiffs a long-awaited opening in those suits.
In most cases, generic drugs can be as good as brand name drugs, but consumer groups, attorneys and some U.S. Supreme Court justices fear their warning labels are not. That's because Federal Drug Administration rules allow brand name drug manufacturers to update their warning labels without FDA approval while generic drug manufacturers can't.
The Supreme Court ruling late last month that state-law failure- to-warn claims against generic drug makers are preempted by federal law - handed down just two years after the Court held that brand- name drug makers could face such suits - creates a legal discrepancy that leaves the majority of patients without recourse, some advocates say. It creates an absolutely untenable distinction in the law between name-brand and generic drugs," said Louis Bograd, senior litigation counsel for the Washington-based Center for Constitutional Litigation, who argued on behalf of the plaintiffs in PLIVA, Inc. v. Mensing.
SCOTUS Decision in Pliva v. Mensing Affects 70 Percent of All Drug Prescriptions WASHINGTON, June 23, 2011 /PRNewswire-USNewswire/ -- Today's U.S. Supreme Court decision in Pliva v. Mensing is a disastrous outcome for patient safety, giving generic drug companies legal immunity when they ignore harmful side-effects of the drugs they manufacture and profit from. This decision eliminates any incentive for generic manufacturers to ensure their drug is safe and adequately warn consumers of their drugs' potential dangers.
Two years after the U.S. Supreme Court ruled in Wyeth v. Levine that state law failure-to-warn claims against brand-name drug makers are not automatically preempted by federal law, the justices are considering whether that same rule applies to generic drug makers. The plaintiffs in PLIVA. v. Mensing and consolidated cases allege that the makers of the drug metoclopramide, the generic version of the diabetes drug Reglan, should have amended its label to include stronger warnings of the risk of tardive dyskinesia, a severe neurological movement disorder.
Federal regulations should be revised to allow generic drug manufacturers to update product labeling to warn patients about risks associated with their drugs, according to a petition filed last month with the Food and Drug Administration. Drug safety would benefit if generic manufacturers - who already have access to real-world information about adverse events - could use FDA procedures currently in place for brand-name manufacturers to revise labeling to warn of risks," said Dr. Sidney Wolfe, of the consumer organization Public Citizen, in a press release.
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