FOR IMMEDIATE RELEASE CIV THURSDAY, MARCH 28, 1996 (202) 616-2765 TDD (202) 514-1888 CIRCA PHARMACEUTICALS PAYS U.S. $2.7 MILLION TO RESOLVE LIABILITY FOR UNTESTED GENERIC DRUGS WASHINGTON, D.C. -- Circa Pharmacueticals Inc., which has paid millions of dollars in fines for violations involving the manufacturing of generic drugs when it was known as Bolar Pharmaceuticals Inc., will pay the United States $2.7 million to resolve allegations it sold untested generic drugs to the government and to government-funded programs from 1986 through March 1991, the Department of Justice announced today. Assistant Attorney General Frank W. Hunger, in charge of the Civil Division, said the agreement, which settles Circa's civil liability under the False Claims Act, 31 U.S.C.  3729, and common law, brings to a total of $13.7 million in fines that Circa and Bolar have paid for generic drug manufacturing violations. "This settlement underscores the government's commitment to fight health care fraud of all types," Hunger said. The Department said today's settlement stemmed from a government investigation that revealed federal violations in Bolar's generic drug manufacturing program during the 1980's and involved Bolar's sale of untested generic drugs to such federal programs as Medicare, Medicaid and components of the Department of Veterans Affairs. Specifically, Bolar sometimes substituted the brand-name drug for the generic version when comparing the effectiveness of brand-name drugs with the generic version, then submitted the results to the Food and Drug Administration to receive approval for the generic drug. Bolar also kept a second set of records, known as "coversheets," to show to FDA inspectors that the drugs were manufactured according to the FDA's formula when in fact they were not. In 1991, Bolar pleaded guilty to 21 violations of generic drug manufacturing and paid $10 million in fines and agreed to withdraw from the market virtually all generic drugs that had received FDA approval. In 1993, Bolar pleaded no contest to one charge of attempted price-fixing of the generic drug, Dyazide, and paid a fine of $1 million. In addition, several Bolar employees, including its president, Robert Schulman, pleaded guilty to various criminal charges relating to Bolar's generic drug programs. ##### 96-144