A top policy official at the Federal TradeCommission (FTC) is working to rally publicand congressional support for action tocurb antigeneric competitive strategies bybranded pharmaceutical makers. FTCCommissioner Jon Leibowitz, a keynotespeaker at the Generic PharmaceuticalAssociation's (GPhA) Second AnnualPolicy Conference in Washington, DC, isconvinced that without vigorous antitrustenforcement, much of the cost savingsexpected from the launch of genericdrugs will be lost.
GPhA's conference also featured presentationsby former Medicare chief MarkMcClellan, MD, PhD, Rep Nathan Deal (R,Ga), and Sens Orrin Hatch (R, Utah) andHenry Waxman (D, Calif). It wasLeibowitz's keynote address, however,that focused on the prickly antitrustissues facing generic drug manufacturers.
Along with others at the FTC, Leibowitzhas been especially critical of the practiceby some brand name drug manufacturersof settling patent litigation by offering"exclusion payments" to keep genericcompetitors out of the market. Accordingto Leibowitz, these are "pernicious settlements" that rob both consumers andthe government of the savings thatwould otherwise result from genericcompetition. Although FTC antitrusterscracked down on these agreements 5years ago, a series of recent federalappeals court rulings now threatens toopen the door for the widespread useof exclusion payments to delay genericdrug introductions.
Leibowitz is hopeful that "the SupremeCourt will eventually weigh in on thisproblem" and close the antigeneric loopholescreated by the Second andEleventh Federal Appeals Circuit. In themeantime, however, antitrust officials atthe FTC have been urging Congress toaddress the issue of exclusion paymentsby drug companies.
One bill already in the hopper—the"Preserve Access to Affordable GenericsAct" introduced by a bipartisangroup of US senators—is being watchedclosely by officials at the commission.Although the FTC has not officiallyendorsed that legislation, Leibowitz hastold Congress that "we strongly supportthe intent behind" that bill.