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Executive Summary

DIRECT-TO-CONSUMER Rx DRUG ADS WILL DRAW HILL HEARING, if planning for such advertising proceeds to the action stage, Rep. Dingell's (D-Mich.) House Commerce/Oversight Subcmte. staff is saying. In a Dec. 30 memorandum to subcommittee members, the staff noted that it is monitoring the concept closely and asserted: "If the pharmaceutical industry, broadcasters, and other media and advertising industry members feel they ultimately stand to gain from initiating this advertising, they should be prepared to explain their calculus in a hearing." The memorandum was prompted by FDA's recent lifting of a moratorium against direct-to-consumer advertising of Rx drugs ("The Pink Sheet" Sept. 16, p. 3) and evidence that the subcommittee staff said it uncovered indicating the Reagan Administration position favors the concept. "This Administration's belief in the freedom to advertise weighed in so heavily that FDA was prevented either from stating its own position that Rx drug advertising is not in the public interest, or even from reporting that the consensus among interested parties was that the disadvantages of this advertising would outweigh its benefits," the memo states. The subcommittee staff reported that the Federal Register notice announcing the end of the moratorium was published after FDA Com. Young met with HHS Exec Secty. David Rust and with Douglas Ginsburg, then Information & Regulatory Affairs Administrator at the Office of Management & Budget. They asked Young why the moratorium was not listed on the agency's 1985 regulatory calendar, the memo states, and "told the commissioner that the FDA's existing regulations were sufficient protection, that they believed the moratorium was an extra-legal restraint on free commercial speech, and that it could not be sustained." Early drafts of the Federal Register notice included the statement that the "majority . . . of the affected groups does not favor advertising Rx drugs directly to consumers at this time," according to the subcommittee staff. In addition, FDA developed a policy statement which was intended for release with the notice and stated: "A broad consensus has emerged in support of the view that, except for institutional and price-comparison advertising, the disadvantages of direct-to-consumer Rx drug advertising outweigh its advantages." However, the memo reports, the "statement of policy was not issued," and FDA's description of the consensus regarding Rx ads for consumers was deleted from the Federal Register notice. "In fact, FDA's whole public presentation was sanitized to remove any negative cast against such advertising, at the HHS Exec Secty. Rust and his staff. The disinfected notice was also cleared in advance by the OMB," the memo states. The staff said "it is becoming clear that the withdrawal of the moratorium has fostered renewed enthusiasm for this advertising." The memo notes that CBS has drafted broadcast guidelines for such ads and discussed them with subcommittee staff ("The Pink Sheet" Nov. 18, T&G-6). However, the staff had no input in their development and does not endorse them. "Another network, reacting to the CBS action, apparently also intends to consider a policy for clearing Rx drug commercials," the memo adds.

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