May 22, 2008

Jeff Perlman, Executive Vice President – Government Affairs
Clark Rector Jr., Senior Vice President – State Government Affairs
Robert Kohlmeyer, Manager – Government Affairs

Chairmen Dingell, Stupak Seek DTC Guidelines From Pharmaceutical Companies

Following a House Energy and Commerce Committee Oversight and Investigations Subcommittee hearing on three specific direct-to-consumer pharmaceutical advertising campaigns, full committee chairman John Dingell, D-Mich., and subcommittee chairman Bart Stupak, D-Mich., sent follow-up letters to the CEOs of the pharmaceutical companies that testified and to the Pharmaceutical Research and Manufacturers Association requesting answers to questions Dingell posed in the hearing. The chairmen asked if the companies would volunteer to abide by a number of "guidelines," including a two-year moratorium on advertising new prescription drugs and to not market prescription drugs until a valid outcomes study of the product is completed. The two-year moratorium was considered and rejected by the committee last summer during consideration of the Food and Drug Administration legislation. A valid outcomes study is an imprecise term that implies finality and could in effect result in a complete ban on DTC advertising. Because it is impossible to reach a point of knowing everything about a product, the study could become a threshold that even aspirin could not reach.
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Merck Agrees to FDA Preclearance

As part of a settlement with 30 state attorneys general, Merck & Co. will submit all of its direct-to-consumer advertisements to the Food and Drug Administration and not broadcast them until the FDA gives specific approval. The agreement could cause the FDA to delay Merck's advertising for any reason. Most companies already voluntarily submit their advertising to the FDA for comments prior to airing; however, the agency does not have the authority to approve the ads. Following the enactment of the FDA Amendments Act, the agency now has the power to fine marketers for false or misleading advertisements. The decision concludes a three-year investigation of the company's marketing of Vioxx and is part of an overall $58 million settlement with the states.
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Massachusetts Rep. to Introduce Online Data Collection Opt-Out Bill

Massachusetts Rep. William Straus, D-Mattapoisett, plans to introduce legislation that would allow users to opt-out of data collection mechanisms on Web sites. The proposal mandates Web sites provide notice of what kinds of data are collected and provide specific data security for users who do not opt-out. Additionally, the bill would limit third-party advertisers to accessing tracking data no longer than 24 months after it is collected. Rep. Straus is seeking co-sponsors before he introduces the bill.

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