April 18th, 2008

Drug Makers Push Easing Off-Label Rules

By Alicia Mundy
The Wall Street Journal

Drug-industry representatives are descending on the capital to protect their freedom to advertise their wares directly to consumers and to push for looser government restrictions on their ability to promote off-label uses of their medicines.

The industry has become worried about a potential regulatory backlash following recent scandals over the marketing of Vioxx and Vytorin, as well as voter concern about increasing drug prices. All three presidential candidates have been criticizing drug makers about pricing. Meanwhile, three congressional committees are pursuing investigations of drug-industry marketing practices.

“We have to be concerned that Congress will act too quickly in this atmosphere, without considering the problems they can cause the public by limiting the information flow to consumers,” said Bob Hogan, chief executive of Cognito Communications, a Connecticut health-care marketing-strategy firm.

Ten major drug companies, including Pfizer Inc.; Bayer Corp., the U.S. unit of Bayer AG; AstraZeneca PLC; and Johnson & Johnson have formed a coalition to push for looser restrictions on off-label marketing. They will submit their arguments Friday to the Food and Drug Administration, which has been soliciting comments on its proposed off-label promotion guidelines. They are represented by former FDA Chief Counsel Daniel Troy, who is working with public-relations giant APCO Worldwide Inc.

Mr. Troy’s group includes patient-advocacy organizations the National Alliance on Mental Illness and the National Organization for Rare Disorders. The group supports the ability of companies to disseminate articles from peer-reviewed medical journals to physicians and hospitals to inform them of new conditions for which drugs already on the market could be used but which the FDA hasn’t formally approved.

The FDA said it isn’t loosening the rules for industry, but clarifying them. Randall Lutter, the agency’s deputy commissioner for policy, said the guidelines mandate full disclosure of any conflict of interest by journal authors in articles used in off-label promotion.

The push for off-label changes came just as the Journal of the American Medical Association suggested in two reports that Merck & Co. played down the potential risk to Alzheimer’s patients of heart attack from its now-withdrawn painkiller Vioxx, and said the company had ghostwritten many academic articles favorable to that drug.

Drug-industry worries about new rules and a chilly climate in Washington were reflected at a conference here Thursday. More than 60% of participants polled during the annual conference sponsored by drug-marketing magazine DTC Perspectives said they think Congress may move to place limits on television advertising by pharmaceutical companies. Drug makers spend about $5.4 billion annually on TV ads, according to Nielsen Monitor-Plus.

One idea the drug marketers don’t like: A proposal that ads contain a phone number that consumers can call to make complaints to the Food and Drug Administration.

Separately, the promotion of Vytorin, a cholesterol drug marketed jointly by Merck and Schering-Plough Corp., is under scrutiny by congressional investigators who have alleged the companies delayed release of a study that raised doubts about Vytorin’s effectiveness. The companies have denied any strategy to withhold information, and said the delay in publishing the study was the result of efforts to resolve problems with certain data.

Drug manufacturers are concerned that marketing strategies could be trimmed after the 2008 elections if Democrats strengthen their control in Congress or take the White House. But there are indications that some politicians won’t wait that long.

The chairman of the House Committee on Energy and Commerce, Michigan Democrat John Dingell, plans to announce a hearing on direct-to-consumer advertising, to take place in a few weeks. Mr. Dingell’s panel will look at Vioxx, Vytorin and an ad blitz for Pfizer’s cholesterol drug Lipitor that used medical inventor Robert Jarvik.

“Drug companies should know that they will be held accountable for inappropriate behavior and inaccurate representations made in their ads,” Mr. Dingell said in a statement.

Sen. Chuck Grassley of Iowa, the ranking Republican on the Finance Committee, and Rep. Henry Waxman, a California Democrat who is chairman of the Oversight and Government Reform Committee, are both investigating drug marketing.


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