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FDA today announced that the Department of Justice (DOJ) will appeal on its behalf a recent decision by the U.S. District Court for the District of Columbia that prohibited FDA from granting "shared exclusivity" to several generic drug manufacturers for paroxetine hydrochloride tablets. "Shared Exclusivity" refers to FDA awarding marketing approval, and the accompanying 180 days of exclusive generic marketing rights, to more than one manufacturer of a generic drug.
FDA's ability to grant shared exclusivity is important to consumers, because it offers a quick way of providing consumers with access to low-cost generic drugs in situations that could otherwise prevent the approval of these drugs. Shared exclusivity also encourages more manufacturers to develop generic drugs earlier, thus providing patients earlier access to lower priced generic versions of some of the most widely used drugs.
Without shared exclusivity, legal wrangling between several manufacturers developing the same generic drug might prevent its approval and availability for quite some time.
In most cases, a single company is eligible for sole 180-day marketing exclusivity for its generic product based on the risk it undertakes when challenging a patent for the innovator's product. However, when different generic drug applicants have valid exclusivity claims on different patents for the same product, these competing claims for exclusivity may block each other so that no application can be approved. To avoid this outcome, FDA determined that, in cases of blocking exclusivities, more than one generic drug applicant may be entitled to shared exclusivity – that is, two or more applicants may be eligible for approval, while the remaining approvals for competitor products would be delayed for 180 days.
FDA has used this mechanism as a way of recognizing the risk various generic drug manufacturers undertake in challenging patents and promoting the availability of lower-cost generic alternatives to the public. Because the court's decision could have far-reaching implications for the public health and generic drug industry, FDA believes it is important that this matter be resolved as quickly as possible.
FDA believes that shared exclusivity and the approvals it permits help facilitate earlier public access to generic drugs in a way that is both equitable and in keeping with the letter and spirit of the law. While this appeal is pending, the agency will continue to award shared exclusivity when applicable. The agency is working closely with DOJ on an appeal to the U.S. Court of Appeals for the District of Columbia Circuit to reverse the lower court's decision.
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