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A recent U.S. Supreme Court decision making it easier for companies to tie the sale of one product to another could make it harder for generic drug firms to challenge brand patents, according to an antitrust watchdog group.
A federal appeals court has affirmed the dismissal of a lawsuit filed by Mylan Pharmaceuticals against the FDA, Watson Pharmaceuticals and Procter & Gamble (P&G) after the agency allowed the two drugmakers to market an authorized version of P&G’s urinary tract infection drug Macrobid during Mylan’s 180-day marketing exclusivity.
The FDA is pushing to expand the generic drug market by challenging a recent court decision providing two generic manufacturers with 180 days of market exclusivity for their version of the cholesterol-lowering drug Zocor, court filings show.
Reps. Henry Waxman (D-Calif.), Frank Pallone (D-N.J.) and Rosa DeLauro (D-Conn.) introduced a bill July 28 that attempts to close the “legal loopholes” the legislators say allow brand drugmakers to stall generic drug entry.
The federal budget reconciliation bill includes a provision that will require brand drug companies to include authorized generics
in their “best price” Medicaid reimbursements — a move applauded by the generic drug industry.
The Senate Appropriations Committee has followed the House’s lead in appropriating more money to the FDA’s Office of Generic Drugs (OGD) than proposed in President Bush’s fiscal 2007 budget, possibly preventing the agency from having to cut programs and impose user fees for generic drug applications.
The FTC is trying to bring a case that will split circuit court opinion and force the Supreme Court to address the issue of “reverse payment” settlements between brand and generic drugmakers, FTC Commissioner Jon Leibowitz said at a hearing on Capitol Hill July 20.
As the battle between brand and generic drugmakers heats up, the judicial and legislative branches of the federal government have found themselves on opposite sides, with the courts generally ruling on behalf of the brand companies and members of Congress heeding their constituents’ calls for lower-priced pharmaceuticals. Two federal courts recently struck down an FTC order that would have banned reverse payments, the arrangement in which brand drug companies pay generic firms not to launch generic drugs. Just hours
after the decision, legislators began introducing a variety of bills to close what they say are loopholes allowing brand drugmakers to delay or discourage market entry of generic drugs. In addition to banning reverse payments, members of Congress want to stop brand drugmakers from undercutting generic drugmakers by selling authorized generics during the six-month period in which some say Hatch-Waxman intended for only the generic drugmaker to sell a version of the product – another issue where generic firms have lost in court. In another move to improve access to cheaper drugs, the House and Senate have recommended more funding for the FDA’s Office of Generic Drugs in an attempt to speed up approvals. Yet there are more roadblocks generic firms must get around, as the Supreme Court issued a decision that could make it harder for generic drugmakers to challenge brand drug patents. This issue of FDL explores how the courts and Congress are addressing the competition between brand and generic firms.
Legislation introduced in the House of Representatives would move the nation’s vaccine safety research from the Centers for Disease Control and Prevention (CDC) to an independent agency within HHS.
The FDA’s proposal to approve the controversial contraceptive Plan B for OTC use has inflamed critics of the agency, leading to a number of new questions about the agency’s decisionmaking and the continuation of a threatened hold against Andrew von Eschenbach's nomination to be the FDA commissioner.
Sanofi-aventis said in a regulatory filing July 31 that it has received grand jury subpoenas in connection with a Department of Justice (DOJ) criminal investigation regarding its proposed patent settlement with Apotex.