AARP is stepping up efforts to lower drug costs by joining three important cases against prescription drug manufacturers which have blocked the availability of lower-priced generic equivalents.

Today, AARP CEO Bill Novelli announced that the organization's attorneys will serve as co-counsel in three lawsuits that involve charges of patent abuse, suppression of generic competition and collusive agreements with generic manufacturers.

The three ongoing class action cases—all in federal court—are In Re: Buspirone Antitrust Litigation, In Re: K-Dur Antitrust, and In Re: Tamoxifen. AARP chose the cases because they involve important drugs that are widely used by Americans 50 and over.

AARP attorneys will serve as co-counsel in the three cases with attorneys associated with the Prescription Access Litigation Project (PAL), a coalition of consumer and health organizations that was launched by Boston-based Community Catalyst last year. Community Catalyst is a national advocacy organization that works in partnership with consumer and community groups around the country to improve health care access.

AARP has launched a large-scale, three-pronged campaign to reduce prescription drug costs that includes education, legislation, and litigation.

This marks the first time that AARP attorneys have co-counseled in federal anti-trust litigation against drug manufacturers. AARP attorneys will represent consumers and consumer groups that have purchased the drugs.

Millions of dollars are at stake annually for older Americans—who account for 42 percent of U.S. prescription drug consumption—and other consumers who purchase prescription drugs.

"Generic drugs approved by the U.S. Food and Drug Administration as equivalents give consumers quality drug alternatives at reasonable prices," Novelli said today. "Our aim is to help people get affordable access to the drugs they need."

Community Catalyst Executive Director Rob Restuccia applauded AARP's decision to join three of PAL's class action lawsuits. "The PAL coalition welcomes the firepower of AARP, firepower that will strengthen our capacity to challenge the anti-competitive activities of some drug companies," Restuccia said.

The three cases include:

• In Re: Buspirone Antitrust Litigation, a suit against Bristol-Myers Squibb Company (BMS) for alleged patent abuse related to a drug used to treat anxiety. The suit is in the U.S. District Court for the Southern District of New York. BMS had a patent for buspirone—called BuSpar. Just as the patent was about to expire, BMS got a new patent for buspirone by allegedly misrepresenting to the FDA that a reasonable claim of patent infringement could be made against generic manufacturers. BMS brought patent infringement litigation against the generic competitors and thereby triggered an automatic 30-month stay of FDA's approval of the generics. The plaintiffs seek injunctive relief to prevent any further alleged anti-competitive manipulation, as well as damages for having to pay high prices for the brand name drug.
  
  
• In Re: K-Dur Antitrust, a class action anti-trust suit alleging illegal agreements by three pharmaceutical companies that prevented the marketing of a low-cost generic alternative to K-Dur20, used to treat the side effects of high blood pressure medications. K-Dur20 is manufactured by Schering-Plough Corporation and is one of the most frequently prescribed drugs to people over the age of 65. The case is in U.S. District Court in New Jersey. Schering-Plough sued Upsher-Smith and ESI Lederle, Inc., a division of American Home Products (now known as Wyeth), for patent infringement when they sought to market a generic equivalent. Then, Schering-Plough settled, agreeing to pay $75 million to the two firms in exchange for the promise to refrain from producing a lower-priced competitor. The agreement prevented other generics from getting into the market. The plaintiffs seek to have the agreements ended, and damages are sought.
  
  
• In Re: Tamoxifen, a class action against AstraZeneca Pharmaceuticals LP, the brand name manufacturer, and Barr Laboratories, Inc., the generic manufacturer, for an allegedly anti-competitive agreement involving one of the most widely prescribed breast cancer drugs. The case is in the U.S. District Court for the Eastern District of New York. Barr abandoned a challenge to AstraZeneca's patent and agreed to refrain from marketing a generic despite a federal district court ruling that AstraZeneca's patent was unenforceable. In return, AstraZeneca agreed to pay Barr $21 million and to supply Tamoxifen to Barr for resale as a "generic". Barr's Tamoxifen is priced only five percent below AstraZeneca's brand name version. The plaintiffs are seeking injunctive relief to prevent similar agreements in the future, and are asking for damages.

AARP's actions come against a backdrop of skyrocketing prescription drug costs. Spending for brand name drugs tripled in the last decade, rising from $40.3 billion in 1990 to $121.8 billion in 2000, and is expected to more than triple to $414 billion in this decade. Generic drugs typically cost 50 percent or less than brand name drugs.

AARP attorneys are participating in these cases as co-counsel in order to ensure that a strong consumer voice is represented throughout the proceedings, including in any settlement.

AARP is involved in two other prescription drug suits centering on state efforts to contain costs. In Pharmaceutical Research and Manufacturers of America (PhRMA) v. Michigan Department of Community Health, before the Michigan Court of Appeals, AARP's filing supports the state program to persuade prescription drug makers to offer rebates to lower the costs the state pays for its low-income residents. In PhRMA v. Tommy G. Thompson, before the U.S. Court of Appeals for the D.C. Circuit, AARP's brief supports Maine's Medicaid waiver demonstration project requiring drug makers to rebate a portion of the price of drugs purchased directly by individuals who are not otherwise covered by the state's Medicaid program.

AARP also filed In Re: Cardizem CD Antitrust Litigation before the U.S. Court of Appeals for the Sixth Circuit (Cincinnati). AARP argued that an agreement by Aventis Pharmaceutical, the maker of Cardizem, a high blood pressure medication, and Andrx, a generic manufacturer, to keep a generic off the market has harmed consumers.

AARP's legal initiatives are one element of a broad campaign to make prescription drugs more affordable. The organization is lobbying for meaningful prescription drug coverage in Medicare. In addition, AARP is expanding its voter education initiatives, including developing voter guides to outline its position on prescription drugs and help its members assess the position of public candidates on the issue.

Throughout the year, AARP members are holding "kitchen table" meetings in key Congressional districts to outline the impact of the high cost of prescription drugs on their personal well-being.

In addition, AARP recently launched a $10 million educational effort—called "Check Up on Your Prescriptions"—to encourage consumers to take steps to use prescription drugs wisely, to increase efficacy, and seek less expensive alternative drugs.

AARP also is working with state legislatures to make drugs more available and affordable, especially for older Americans and those with low or moderate incomes. The state advocacy activities include expanding drug coverage to Medicaid populations, bulk purchasing, and requiring significant rebates from manufacturers. AARP is seeking to maintain existing programs in more than 35 states that have been under pressure because of state budget difficulties.

AARP publications, which reach the organization's 35 million members, are carrying information about wise use of medications, the Association's efforts to reduce costs and achieve federal and state legislation. The AARP Bulletin recently ran a cover story on "What's Fueling Drug Costs?"

AARP is a nonprofit, nonpartisan membership organization for people 50 and over. It provides information and resources; advocates on legislative, consumer, and legal issues; assists members to serve their communities; and offers a wide range of unique benefits, special products, and services for its members. These benefits include AARP Webplace at http://www.aarp.org/, Modern Maturity and My Generation magazines, and the monthly AARP Bulletin. Active in every state, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands, AARP celebrates the attitude that age is just a number and life is what you make it.

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