Saturday, June 28, 2008

Big Pharma Agrees To Stricter Ad Rules

(previously published here at

Washington - Top drug manufacturers including Johnson & Johnson, Merck and Pfizer agreed last Monday to a six-month moratorium on direct-to-consumer television advertising for new prescription drugs and limitations on how doctors are used in their ads.

The agreements came amid increasing pressure from the Congressional House Energy and Commerce Committee and the American Medical Association (AMA) following earlier controversy surrounding deceptive advertising for anti-cholesterol drugs such as Lipitor, Procrit and Vytorin.

In signed letters, the executive directors of Johnson & Johnson, (J&J), Merck & Co., Merck/Schering-Plough, and Pfizer agreed to take steps towards implementing these recommendations.

Meanwhile, the Pharmaceutical Research and Manufacturers of America (PhRMA) agreed to further meetings with the committee before agreeing to any particular changes at the moment.

All of the companies agreed to adhere to the AMA's guidelines as to the use of actors and health professionals. Specifically, they will continue to identify instances in which an actor portrays a physician, as well as whether the actor was compensated for their appearance. Johnson & Johnson will discontinue use of doctors entirely to discuss the benefits of a drug.

In the letters, each company also stated that the six-month moratorium simply formalized their existing practice of educating doctors before moving to consumer communications.

"We have adopted internal guiding practices on direct-to-consumer advertising for prescription drugs [that] requires our operating companies spend at least six months after approval of a new medicine educating health professionals before commencing a direct-to-consumer advertising campaign," wrote William C. Weldon, chairman-CEO of J&J.

He added that since the advertisements are in line with FDA approved labeling and measures of outcomes, they are an important tool to provide information to patients and physicians, and "a particular fixed period of time for an advertising moratorium is appropriate in all circumstances."

Rep. John Dingell, D-Mich., and Rep. Bart Stupak, D-Mich., chairmen of the committee's oversight and investigations panel, said they were pleased with this response, but wanted the drug companies to adopt the recommended two-year moratorium.

According to Mr. Stupak, he and Mr. Dingell called for the May 8 hearing of the House Energy and Commerce Committee, entitled "Direct to Consumer Advertising: Marketing, Education or Deception?", to both renew pressure and renew the struggle within Congress to strengthen government regulation over such TV commercials. It was also a step towards granting the Food and Drug Administration the right to force changes in the ads before they air.

"Although we appreciate the drug companies' willingness to change some of their business practices, they have not agreed to all of our requests, which would protect consumers from misleading and deceptive advertising," said Mr. Stupak.

Even with these agreements and the potential for future legislation, the debate will go on. Part of that debate lies in the fact that running these ads is mutually beneficial for both the pharmaceutical companies and the TV industry.

Since 1997, when the government relaxed rules on TV and radio ads, pharmaceutical companies shortened the warnings on side effects in their commercials and spent about $14 million on broadcast and cable TV ads for prescription drugs.

In 2007, drug makers spent over $5 billion on direct-to-consumer ads, according to Nielsen Monitor-Plus; more than half of that on television.

"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 in favor of stricter limits on direct-to-consumer drug marketing.

Ken Johnson, a PhRMA vice president, challenged that in a May article in the Wall Street Journal. He insisted that 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."

Still, many consider the ads to be intentionally misleading. "Direct-to-consumer ads often portray drugs through rose-colored glasses by including more information about a drug's benefits than risks," said Dr. Nancy Nielsen, AMA President-elect, in testimony at the congressional hearings.

"Imbalances in these ads can diminish patient understanding of certain drug risks, and increase the need for an ongoing dialogue between patients and physicians about the benefits and risks of prescription drugs," Dr. Nielsen added.

Reporting contributed by and The Wall Street Journal.

Heather Chin can be reached at

©The Evening Bulletin 2008

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