PhRMA Guideline Revisions Don't Go Far Enough for Legislators

Stupak: Some DTC Changes Merely a 'Rewording' of Current Rules

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WASHINGTON (AdAge.com) -- The Pharmaceutical Research and Manufacturers of America is revising some of its guidelines for direct-to-consumer drug ads and the revisions are getting less-than-encouraging reviews from some key legislators.

U.S. Sen. Ted Kennedy, D-Mass., chairman of the Senate Health Education Labor and Pensions committee, today responded to the changes by calling for quick confirmation of a new Food and Drug Administration commissioner and more money to enforce FDA laws, including those aimed at reviewing drug advertising.

"The new administration needs to ask Congress for the resources it needs to do its job, and the new administration needs to nominate a commissioner who is committed to enforcing the law," said Mr. Kennedy. "Congress then needs to provide those resources and act quickly to confirm the nominee for commissioner."

Meanwhile in the House, Rep. John Dingell, D-Mich., outgoing chairman of the House Energy and Commerce Committee, and Rep. Bart Stupak, chairman of the committee's oversight and investigations panel, commended the revisions, but said they don't go far enough. The committee has been investigating some the claims made in DTC ads.

The two said the revisions directly address some issues that have surfaced in hearings, notably restricting the use of physicians and actors in DTC ads, but fail to endorse others they had urged, including a two-year ban on DTC ads for new drugs.

"Although this revision is the first step toward protecting American consumers, there is much more that can be done," said Mr. Dingell. "We look forward to working with PhRMA to add further consumer protections into their policies."

"On the one hand, PhRMA has taken our committee's concerns seriously by revising parts of their DTC code. On the other hand, some of these changes are merely a rewording of prior policy that does nothing to increase consumer protection," Mr. Stupak said.

The guideline changes approved by PhRMA says when actors play the part of health-care professionals in ads, they should be identified as actors. In addition, actual physicians featured should be identified as compensated endorsers if they are paid.

In another change, any endorsements by celebrities must reflect the celebrity's personal experience.

In a third change, DTC ads "containing content that may be inappropriate for children" should be placed in media in which at least 90% of viewers or readers are over 18. The change could affect media placement for erectile-dysfunction drugs.

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