LOS ANGELES – Taking an aggressive stand against illegal marketing to doctors, seniors through the Prescription Access Litigation (PAL) project filed a lawsuit today accusing Pharmacia (NYSE:PHA), a major pharmaceutical company, of doing an end-run around FDA regulations by improperly promoting "off-label" use of its drug. They charge that despite failing to win government approval to advertise the drug for such use, the company sought alternative means to publicize the off-label use in order to enter an additional multi-million dollar segment of the market.

"Over and over again, in more and more cunning ways, the pharmaceutical industry is putting profit ahead of consumers' physical and financial well-being," said PAL Director Ahaviah Glaser. "The FDA regulations exist to protect consumers and Pharmacia's efforts to circumvent those regulations without regard for anything but its own bottom line must stop."

The drug, BEXTRA, was created by Pharmacia to capitalize on the growing demand for pain relief medication. When the company submitted the drug to the FDA, the complaint alleges, it applied for approval for treatment of both chronic and acute pain. The FDA granted approval only for treatment of chronic pain among those suffering with arthritis, osteoporosis and menstrual cramps while specifically rejecting approval for acute pain based on safety and efficacy concerns.

In an effort to create demand in areas not approved by the FDA - known as off-label use - Pharmacia hired Scirex, a clinical testing firm owned in part by Omnicom, one of the world's largest advertising agencies. According to the complaint, Scirex was hired to help exploit a loophole in government regulations that prohibit the promotion of drugs for unapproved uses, except in published research and medical education.

According to the complaint, Scirex recruited dozens of patients with impacted molars and dosed them with BEXTRA, and concluded that the drug was effective in treating adults with acute pain, although independent physicians reviewing the research doubt the conclusions.

Armed with the spurious information, the complaint contends, doctors from Pharmacia and Scirex published the results in the May 2002 edition of the Journal of the American Dental Association (JADA), a widely read journal for dentists - a group constantly dealing with acute pain concerns of patients.

"The intent of the FDA exemption is to promote professional dialogue regarding pharmaceutical science," said Steve Berman, the PAL lead attorney who filed the lawsuit on behalf of the Congress of California Seniors. "Instead, Pharmacia twisted the use of the exemption to create market demand for a use they knew was improper. They used scientific literature as propaganda.

"We intend to prove that, in effect, Pharmacia told Scirex 'we have a hammer, find us a nail,'" Berman noted.

As a result of the publication and well-organized marketing effort by Pharmacia's sales force touting the study, BEXTRA sales skyrocketed to $139 million in the third quarter of 2002, a significant portion from off-label sales, the suit alleges.

Meanwhile, in November 2002, Pharmacia and the FDA issued a warning to healthcare professionals about potentially life-threatening skin reactions from the drug.

The suit cites violations of the California Unfair Competition Law in the company's efforts to deceive consumers by managing the publication of the JADA article and the company's intent to have the study promote the drug for off-label use. The suit asserts that Pharmacia violated Untrue and Misleading Advertising sections of the California code.

The suit, filed in California Superior Court in Los Angeles, asks the court to order Pharmacia to immediately stop promoting BEXTRA's off-label use, to disgorge the profits it received through illegal practices, and to publish notice of the truth regarding BEXTRA.

The Congress of California Seniors is a non-profit organization representing 650,000 senior citizens in California.

Prescription Access Litigation (PAL)
Since its launch nearly two years ago, the Prescription Access Litigation (PAL) project has filed 13 sets of lawsuits targeting drug industry practices that illegally push the price of prescription drugs beyond the reach of the American consumer. A project of Boston-based Community Catalyst, PAL is on the ground in 34 states and the District of Columbia; the coalition is comprised of 88 state, local, and national senior and consumer health advocacy groups fighting to make prescription drugs affordable.

Community Catalyst is a national health care advocacy organization dedicated to building consumer and community participation in the decisions that shape our health system. Working in partnership with state, local, and grassroots consumer groups in over 30 states, Community Catalyst has helped preserve over $16 billion in community health assets as hospitals and health plans around the country have become for-profit corporations. It works on a range of health care access issues, including today' struggle to preserve Medicaid services and other health programs amid plunging state revenues nationwide.

Congress of California Seniors
As an umbrella organization for hundreds of affiliated groups, CCS has a combined membership of over 650,000 Californians. This broad-based coalition includes a variety of senior advocacy organizations such as the California Legislative Council of Older Americans, Gray Panthers, International Senior Citizens Association (ISCA), and Older Women's League (OWL). In addition, CCS represents retired public employee organizations such as the California Federation of Teachers (ATF AFL-CIO), Retired Public Employees Association (RPEA), California School Employees Association (CSEA), the Retired Division of the California State Employees Association (CSEA), and the California Federation of the National Association of Retired Federal Employees (NARFE). Member organizations also include the Federation of Retired Union Members (FORUM), as well as retiree clubs representing many trade unions and international labor organizations.

CONTACTS:
Steve Berman 206-623-7292
Hagens Berman
[email protected]

Laurie Covens 617-275-2805
Community Catalyst/PAL
[email protected]

Christina Weber 617-338 6035 ext 0
Community Catalyst
[email protected]

About Hagens Berman

Hagens Berman Sobol Shapiro LLP is an investor-rights class-action law firm with offices in 10 cities. The firm represents whistleblowers, workers and consumers in complex litigation. More about the law firm and its successes can be found at www.hbsslaw.com. The firm's securities law blog is at www.hbsslaw.com/blog/hagens-berman-blog.

Media Contact
Ashley Klann
(206) 268-9363
[email protected]