FDA to Examine Hepatitis C Campaign

ByABC News

W A S H I N G T O N, Sept. 14, 2000 -- U.S. regulators said today they would review whether Schering-Plough Corp.violated federal rules on advertising and promotion with acampaign that could boost sales of the company’s hepatitis Ctreatment.

A Food and Drug Administration spokeswoman said the agencywould examine documents uncovered by The Washington Post, whichreported Tuesday that Schering-Plough was waging an aggressivecampaign to raise awareness of hepatitis C.

The campaign could help increase sales of Schering-Plough’sRebetron, the drug considered the gold standard for treatingthe liver-destroying disease, and may violate FDA rules, thePost said. Rebetron treatment costs $18,000 a year.

The FDA spokeswoman said the newspaper had offered toprovide documents regarding the campaign to the agency.

FDA May Review

“We said we would review them if we receive them,” thespokeswoman said.

While regulators encourage companies to support educationalcampaigns, FDA officials want to know the extent ofSchering-Plough’s influence and control over informationprovided by coalitions that were billed as grass-rootsorganizations, the Post said.

Also, FDA officials are looking into whether the Madison,N.J.,-based company may have violated federal advertising rulesby billing a marketing campaign as an educational effort, thePost reported.

The FDA spokeswoman said she could not comment further onthe Schering-Plough case. The FDA routinely reviews drugcompany promotion activities, she said.

“Any time someone has documents that demonstrate possibleillegal promotional activity, we’d like to see them,” shesaid.

The Washington Post reported that Schering-Plough paidpublic-relations executives to recruit volunteers, packageeducational materials and lobby state legislatures to spendmore money to treat hepatitis C and raise awareness.

No Comment from Company

The executives, who portrayed themselves as members of thegroups, also directed people to toll-free numbers paid for bySchering-Plough, the Post said.

Schering-Plough spokesman Robert Consalvo could notimmediately be reached for comment, but he told the Post thecoalitions provide balanced and helpful information.

“We don’t think we’re being secretive at all,” he told thepaper. “What this is is an education and awareness campaign.”

Hepatitis C infection can be dormant for years without anysymptoms, delaying treatment while the blood-borne virus harmspatients’ livers. An estimated 4 million Americans are infectedwith the virus.

People at risk include intravenous drug users, people whohave had numerous unprotected sexual contacts and those whoreceived blood transfusions before 1992.

Schering-Plough’s shares, which trade on the New York StockExchange, were down 1/8 at $42-7/8 in late morning.

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