February 3, 2012
Groups Make Proposal to ICANN
AAF, many of its corporate members, local advertising federations and a large group of other businesses and associations, have written a letter to the Internet Corporation for Assigned Names and Numbers (ICANN) proposing a way forward as ICANN begins to accept applications for new top level domains (TLDs). The letter proposes a potential solution that will allow ICANN to move ahead with the creation of new TLDs while affording protections for brand and copyright owners. Under the proposal:
all NGOs, IGOs and commercial stakeholders concerned about protecting their brands should be given the opportunity to have those brands registered, without cost, on a temporary "Do Not Sell" list to be maintained by ICANN during the first application round (any interested party which does not want to have its brands on the Do Not Sell list and would rather apply for a TLD would be free to do so). We will assemble a team from the interested constituencies to work with ICANN leadership during the first application round. If this group achieves consensus with respect to any proposals, those proposals will be voted on by the Board. At the end of the first application round, should the parties continue to disagree, all parties will be free to pursue their legal and equitable rights without prejudice.
AAF believes this reasonable proposal affords a solution that will protect the interests of all concerned. We hope to receive a positive response from ICANN in the very near future.
Study Finds Consumers Not Significantly Distracted From DTC Warnings
A new Distraction Study released by the Food and Drug Administration found that simultaneous visuals and background images in direct-to-consumer advertising for pharmaceuticals do not significantly impair consumer understanding of the reading of the “major statement” of risks and warnings.
This did not meet with the FDA’s expectations. In a March, 2010 Federal Register notice requesting comment on the agency stated, “When elements of the advertisement such as images, text, graphics or sounds are presented in such a way as to significantly detract from the major statement, consumers are likely to be deterred from attending to and comprehending the risk information being presented.”
The FDA has temporarily reopened its comment period on the proposed rulemaking to define “clear, conspicuous, and neutral” in DTC ads. It released a Federal Register notice stating that it has added the Distraction Study to the documents already assembled in this docket and is asking for comments specific to the study. The AAF, as a member of The Advertising Coalition, has already submitted comments to the FDA.
New DTC Regs Not a Current Top FDA Priority
House Energy and Commerce Subcommittee on Health recently held a hearing on reauthorization of the Prescription Drug User Fee Act (PDUFA). Past debates about PDUFA have occasionally included criticisms of direct-to-consumer advertising of pharmaceuticals. The only notable mention of DTC advertising came during the Q&A portion when Rep. Jan Schakowsky, D-Ill., asked FDA Commissioner Peggy Hamburg why the agency did not include any DTC provisions in its draft reauthorization language recently sent to Congress. Commissioner Hamburg indicated that FDA decided to leave out DTC ads largely because of budget constraints and other priorities that FDA needs to address. A central theme of the hearing was that FDA has many responsibilities it must continue to manage, both domestic and foreign, in major key areas such as drug approvals, inspections, and conflict of interests.
Judge Hears Arguments Over Advertising Rules Injunction
Late last year, U.S. District Court Judge Richard Leon issued a temporary injunction preventing the FDA from enforcing rules requiring tobacco companies to display a rotating series of graphic images and warnings in cigarette advertising and on packaging. The images would have occupied the top 20% of an advertisement, and the top 50% of the front and back panels of the product packaging.
On January 31, the FDA tried to convince Judge Leon to set aside the injunction before the matter goes to the U.S. Court of Appeals, which will hear the matter in April. Judge Leon appeared somewhat skeptical of the government’s arguments, but promised to fairly considered the matter and issue a ruling before the April proceedings begin. The AAF and ANA submitted an amicus brief with the court in favor of maintaining the injunction and striking the rules on First Amendment Grounds.
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