June 19, 2008

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

Drug Companies Agree to Six-Month DTC Advertising Moratorium

Johnson & Johnson, Pfizer, Merck and Schering-Plough have agreed to a six-month moratorium on new drug advertising and will modify practices concerning actors portraying doctors and compensated endorsers in DTC ads. The announcements were made in letters responding to House Energy and Commerce Committee Chairman John Dingell, D-Mich., and House Energy and Commerce Committee Oversight and Investigations Subcommittee Chairman Bart Stupak, D-Mich., who asked the companies to comply with several specific proposals concerning DTC advertising. In addition to the actors and endorsement guidelines, the letters asked the drug manufacturers to adhere to a two-year moratorium on new drug advertising, to not air any DTC advertising until a valid outcomes study is conducted and completed, to not market off-label uses for prescription products in DTC ads, to include the FDA's MedWatch phone number in DTC ads, and to include "black box" warning statements in advertising when the FDA requires such warnings on product labeling.

The companies expressed reservations over the valid outcomes proposal, saying that such a mechanism would restrict patient access to potentially life-saving treatments. The companies stated they would defer to FDA guidance concerning the remaining issues, unless the company already complied with the proposal. Additionally, Pharmaceuticals Research and Manufacturers of America (PhRMA) said they will discuss its Guiding Principles with the committee and seek its input. In a statement, Dingell said that the responses were an important first step in the subcommittee's review of DTC advertising, and he looks forward to further discussion with the companies and PhRMA. Copies of the letters sent to the pharmaceutical companies, and their responses, are available here.
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Senators Introduce Commercial Text Message Bill

Sens. Gordon Smith, R-Ore., Ben Nelson, D-Fla., Mark Pryor, D-Ark., and Olympia Snowe, R-Maine, have introduced legislation that would permit cell phone users to opt-out of receiving all unwanted commercial text messages. S. 3138, the Junk Text Message Prevention Act, would include text messages in the scope of the federal Do-Not-Call Registry. The bill would clarify and strengthen powers given to the Federal Communications Commission and the Federal Trade Commission concerning unwanted text messaging. At last month's FTC workshop on mobile marketing, major cell phone carriers highlighted mechanisms already in place that allow consumers to block any surreptitious or otherwise unwanted text messages. Unsolicited commercial messages already violate several laws, including CAN-SPAM and the Computer Fraud and Abuse Act, which bans any disruption of consumer networks.
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Congresswoman Seeks Relief From Loud Commercials

Rep. Anna Eshoo, D-Calif., has introduced a bill that would require the Federal Communications Commission to ensure "television advertisements not be excessively noisy." H.R. 6209, the Commercial Advertisement Loudness Mitigation (CALM) Act, would direct the FCC to enact standards preventing commercials from being broadcast at louder volumes than programming. More broadly, the bill would prohibit ads that are "excessively noisy or strident." According to Eshoo, "Most Americans are not overjoyed to watch television commercials, but they are willing to tolerate them to sustain free over-the-air television. What annoys all of us is the sudden increase of volume when commercials are aired." The bill was referred to the House Energy and Commerce Committee, but no hearings are scheduled.
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Behavioral Advertising Bill Introduced in Massachusetts

The Massachusetts legislature this week introduced a behavioral advertising bill similar to earlier measures in the New York and Connecticut state assemblies. House Bill 4822, the Online Advertising Act, introduced by Rep. William Straus, D-Mattapoisett, would require that companies provide notice of data tracking activity, security of consumers' personal information and deletion of personal information after 24 months. Additionally, the legislation would provide consumers the ability to opt-out of all behavioral tracking and give them access to personal information stored by a company. The bill would prohibit marketers from using financial, medical or other sensitive data for marketing purposes and would penalize Web companies who use any personal information without consent. The AAF believes that absent any demonstrable consumer harm or concern with Internet advertising, additional government regulation is unnecessary.
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