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Generic drug company withdraws lawsuit against FDA regarding ‘authorized generics’
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PITTSBURGH, Pa. — A generic drug company that was suing the Food and Drug Administration over its policy of allowing “authorized generics” has withdrawn the suit to consider additional legal options, according to a press release from the company.
The generic drug company, Mylan Pharmaceuticals Inc., filed a notice for voluntary dismissal without prejudice of a lawsuit it filed in the Federal District Court for the Northern District of West Virginia against the FDA regarding its position on the issue of authorized generic drugs.
The term “authorized generics” refers to a practice that some branded drug manufacturers have used, in which the manufacturer renames its own product and sells it at a lower cost through a licensed distributor, according to a report by the Associated Press.
Mylan Pharmaceuticals contended that this practice is intended to help brand drug manufacturers to maintain a portion of the drug’s market while punishing generic drug manufacturers, the AP reported.
Robert J. Coury, vice chairman and chief executive officer of Mylan, said in a press release that the company dismissed the lawsuit to allow it to refile the suit at a later time to incorporate additional facts recently disclosed by counsel for the FDA and another drug company.
The recently disclosed facts could have a “significant bearing on the ‘authorized generic’ question and the considerable anticompetitive effects of authorized generics on the pharmaceutical industry,” the Mylan press release said. Mylan now believes additional potential claims may be available to the generic pharmaceutical industry, the release said.
The Generic Pharmaceutical Association said in a press release that it opposes the practice of allowing authorized generics because it can “devalue the 180-day exclusivity provisions of the Hatch/Waxman Act.” That law was meant to provide incentive for generic drug companies to bring generic versions to market.
Judge Irene Keeley, who was set to rule on the suit on Aug. 30, had called the case “extremely compelling” and said that Congress had left what she called “a gaping black hole in federal prescription drug laws by apparently failing to anticipate the advent of so called authorized generics,” according to the AP report.