May 8th, 2008

New Rules on Drug Ads Sought

By Alicia Mundy
The Wall Street Journal

WASHINGTON—Congressional Democrats are renewing pressure on the drug industry’s direct-to-consumer advertising amid growing tension over the marketing of several best-selling drugs.

Last year, Democrats lost a fight over proposals to strengthen government regulation of TV commercials for prescription drugs. But recent controversies over the marketing of anticholesterol drugs Vytorin and Lipitor and of Procrit, which helps treat anemia, have given Democrats on the House Energy and Commerce Committee ammunition for a new battle.

A subcommittee led by Michigan Democrat Bart Stupak has scheduled a hearing for Thursday with an agenda titled “Direct to Consumer Advertising: Marketing, Education or Deception?” Mr. Stupak says he wants to lay the groundwork for future legislation to tighten controls on drug marketing, including giving the Food and Drug Administration the right to force changes in TV drug ads before they are broadcast.

Direct-to-consumer drug marketing brings in billions of dollars in sales for drug makers and for the television industry. In 1997, the government relaxed rules on TV and radio ads, allowing drug makers to shorten the warnings on side effects in their commercials; since then, pharmaceutical makers have spent about $14 billion on broadcast and cable TV ads for prescription drugs.

Such advertising has become a major revenue stream for the TV industry. In 2007, drug makers spent more than $5 billion on direct-to-consumer ads, according to Nielsen Monitor-Plus; more than half of that was spent on television.

The National Association of Broadcasters, a TV-industry lobbying group, and Pharmaceutical Research and Manufacturers of America, a drug-industry trade group, have beaten back several congressional efforts to toughen regulations on TV commercials for drugs.

“The drug and TV and cable industries have formed a cabal here to protect their revenues,” said Gene Kimmelman of Consumers Union, an advocacy group that wants stricter limits on direct-to-consumer drug marketing.

Ken Johnson, a PhRMA vice president, says consumer advertising for prescription drugs “brings patients into their doctors’ offices and helps start important doctor-patient conversations about conditions that might otherwise go undiagnosed or untreated.”

The renewed debate about drug marketing was spurred in part by several recent high-profile campaigns. Merck & Co. and Schering-Plough Inc. have been criticized for heavily promoting the cholesterol drug Vytorin while failing to disclose a study that raised questions about the drug’s effectiveness.

Committee members plan to question officials of Pfizer Inc. about ads for its cholesterol drug, Lipitor, which featured Robert Jarvik, the inventor of the artificial heart. Mr. Jarvik isn’t a practicing doctor, but he “appears to be giving medical advice,” according to the committee, which suggested that the ads are misleading. Pfizer and the joint venture between Merck and Schering-Plough have defended their ads as accurate.

In an interview, Mr. Stupak said Procrit presents a particular problem. Procrit marketers Johnson & Johnson and its subsidiary Ortho Biotech continued to broadcast ads promoting Procrit as an antifatigue drug—a use for which the drug wasn’t approved—despite repeated requests from the FDA to the companies to revise their commercials.

“They advertised this for seven years,” said Mr. Stupak, calling this a violation of off-label-use prohibitions. Mr. Stupak said political appointees leading the FDA’s legal advisory team effectively shut down the FDA’s marketing regulators during the current administration.

The FDA’s letters to J&J and Ortho Biotech complaining about the Procrit TV commercials and print ads touting fatigue relief stopped in December 2001, shortly before the agency instituted a policy of routing warnings to companies through the FDA chief counsel’s office for review, Mr. Stupak said. The FDA didn’t respond to a request for comment.

The company stopped running the Procrit TV ads in 2005, and the print ads stopped in 2006. Procrit was later linked to increased risk of tumor growth in certain patients, and a panel of experts advising the FDA questioned whether the drug was being overused in cancer patients.

In a statement, a representative for Johnson & Johnson said the broadcast advertisements for Procrit, which ran from 1998 to 2005, “were accurate, substantiated by clinical research, and consistent with the FDA-approved label at the time they aired.”


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