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As major pharmaceutical companies’ patent monopolies over lucrative drugs wind down toward expiration, the legal maneuvering to keep generic competitors out of the market heats up. One controversial means of delaying low-priced generics entering the market in recent years has been use of the regulatory process known as citizen petitions to the Food and Drug Administration, which temporarily halts generic approvals while the FDA investigates safety challenges raised in the petitions. “For a relatively small amount of money, a company can inflict substantial harm on a competitor,” said David Balto, a Washington attorney and former assistant director in the Federal Trade Commission’s Bureau of Competition. “It becomes attractive to keep rivals off the market and there is no better example than the citizen-petition process,” Balto said. The citizen-petition review process allows anyone to cite specific safety concerns and request further investigation or withholding of a generic. As a patent is about to expire, generics makers can seek streamlined FDA approval if their drug is a bioequivalent of the patented version. It is clear the objective of many petitions is delay for financial advantage. The petitions arrive for FDA review as the brand-company drug expires, and they are based on information available much earlier, according to Balto. Of 45 petitions seeking review between 2003 and mid-2005, the FDA had ruled on 21, denying 20 of them, according to the FDA. No “11th-hour” petitions, or those filed on the eve of a generics’ approval, have been approved. “Regardless of the merits, the brand companies know the FDA will delay the generic while they consider the petition,” said William Rakoczy of Chicago’s Rakoczy Molino Mazzochi Siwik. In December, the FDA approved Anchen Pharmaceuticals Inc.’s generic version of GlaxoSmithKline PLC’s Wellbutrin XL, an antidepressant with $1.4 billion in 2005 sales. But the approval came after two failed court efforts to enjoin generic sales filed by Biovail Corp., which markets Wellbutrin in partnership with Glaxo. Biovail Corp. v. FDA, 448 F. Supp. 2d 154 (2006). A citizen petition asked the FDA to investigate the potential risks of seizures in the generic. “There’s no question about it . . . the petitioning process is used by a lot of companies to delay action by the FDA,” said Donald Mizerk of the Washington office of Winston & Strawn and Anchen’s attorney. Mizerk said that, when a federal judge indicated on a Friday he would allow the FDA to issue the Wellbutrin generic, the FDA was e-mailed by Sunday with new criticisms of the generic to examine on Monday in a last-ditch effort to extend the delay. Biovail declined to comment on the issue but in a 2006 statement said its petition was “intended to protect the public against the potentially harmful effects of generic versions of Wellbutrin XL that may not be a bioequivalent to Biovail’s branded product, or may be misleadingly labeled.” While individual companies declined to discuss the issue, an association representing large pharmaceutical firms disputed allegations the petition process is abused. “Citizen petitions are filed infrequently,” said Scott Lassman, senior assistant general counsel for Pharmaceutical Research and Manufacturers of America (PhRMA). He noted that of 104 name products, just 12 petitions were filed, according to a 2002 Federal Trade Commission study. The evidence that they are filed purely to block generics is “very scant,” he said. Even though Congress is poised to impose legislative reforms to curb manipulation of the regulatory process and litigation excesses, the amount of money at stake suggests the contentious litigation will remain a big issue for several years. It is projected that $29 billion worth of drugs will go off patent next year, $21 billion in 2009 and $44 billion in 2010, said, Andrea Hofelich, spokeswoman for the Generic Pharmaceutical Association in Washington. The U.S. Senate last week inserted petition reforms in a major FDA overhaul bill. The measure would not allow a petition to delay FDA approval of a generic unless delay is necessary to protect public health. As a check on competitors, petitioners must verify who is making the challenge and whether they expect to be paid for filing the petition. Congress must get annual reports on delays to generics based on the petitions. Lassman said PhRMA opposes the citizen-petition reforms and predicted that, if the measure becomes law, it may produce even more litigation. “These new requirements are so onerous, companies may decide to go to court to seek whatever they are seeking currently in petitions,” he said. In conjunction with petitions, both sides engage in a host of litigation tactics to gain the upper hand. Brand companies may seek temporary restraining orders against generics during FDA petition reviews and the generics may file patent challenges in hopes of invalidating a brand drug’s monopoly. For example, in 2005, one month before Mylan Laboratories Inc. was expected to launch sales of a generic version of Alza Corp.’s Ditropan XL, an incontinence treatment, Alza filed a citizen petition challenging the generic. Although the FDA ultimately gave final approval to Mylan, the delay gave Alza months of exclusive sales at an estimated $1.8 million daily. Heather Bresch, Mylan’s head of North American operations, said that final approval of generics is held in limbo while brand companies receive millions for each day they delay competition and consumers lose access to lower-cost generics. To be sure, there are good reasons for the citizen-petition process. Last year, the governors of Kansas, Minnesota, Vermont and Wisconsin filed a petition asking the FDA to provide guidance that would speed introduction of generic versions of insulin and human growth hormone. Other petitions from public watchdog groups have called for removal of some drugs alleged to produce dangerous side effects. But during a November hearing in Los Angeles in the Wellbutrin dispute, U.S. Magistrate Judge Rosalyn Chapman said to Mizerk of Biovail’s safety concerns, “This is all about money . . . Maybe they think I think it’s about safety, but I think it’s all about money.”

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