Briefly in the news

-- Deepa Bharath

A Costa Mesa-based pharmaceutical company has agreed to plead guilty

to federal securities fraud because it did not disclose to the public

that a drug it produced was not approved by the Food and Drug

Administration, officials said Tuesday.

ICN Pharmaceuticals Inc. filed a plea agreement Tuesday in U.S.

District Court in Los Angeles. In the agreement, the company agreed to

pay a criminal fine of $5.6 million. Also, it will be placed on probation

for three years and will be required to create a corporate compliance

program to prevent future violations, officials said.

ICN developed Ribavrin, a drug to treat hepatitis C, according to

federal officials. The company had applied to the FDA in 1994 but

received a denial from the agency later that year. The FDA concluded that

data from clinical studies was not enough to approve the drug’s use,

officials said.

ICN then issued a press release saying it intended to file an amended

application to the FDA but then received a second letter from the agency

stating additional studies would not change its decision.

Officials said ICN did not disclose the contents of the second letter

until February 1995. The company continued to make statements about the

FDA application despite that letter, failing to mention the FDA’s

position to the public, officials said.

ICN is scheduled to be arraigned on the charge Dec. 17 in the district

court in Los Angeles.