P. M. BRIEFING : 2 Companies Fined $400,000 in Generic Drug Payoff Scandal

A federal judge fined Par Pharmaceutical Inc. and its Quad Pharmaceuticals unit a total of $400,000 today for their role in a Food and Drug Administration payoff scandal involving generic drugs.

Par was fined $150,000 and Quad $250,000 in a proceeding before U.S. District Judge John Hargrove.

Par and Quad faced maximum fines of $500,000 each after agreeing to plead guilty to criminal charges stemming from a nearly two-year government probe of the generic drug industry and its regulation by the FDA.

In July, federal prosecutors had charged that Par and Quad executives gave cash payoffs to an FDA chemist when the chemist was reviewing the companies’ drug applications.

Par, based in Spring Valley, N.Y., remains the focus of a separate criminal investigation being pursued by the U.S. Justice Department.

The staff of the House Energy and Commerce Committee’s investigations subcommittee disclosed in September that Par was under Justice Department investigation.

The subcommittee staff said in a memo that Par’s drug development process was found to be “rife with problems such as material false statements, systematic destruction of unfavorable test results . . . and material alterations in chemical formulations between . . . tested and marketed products.”