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DRUG PROMOTION LEGISLATION: FDA COM. KESSLER WILL BE "SENSITIVE"

Executive Summary

DRUG PROMOTION LEGISLATION: FDA COM. KESSLER WILL BE "SENSITIVE" to suggestions for "enhanced statutory authority" to support FDA's control of pharmaceutical marketing and promotional activities. Newly confirmed FDA Commissioner David Kessler, MD, declined to rule out the need for new legislative authority in the area of promotional controls in a recent written Q-&-A exchange with Sen. Kennedy (D-Mass.). The questions were posed by Kennedy to Kessler as part of an abbreviated confirmation procedure for the new commissioner ("The Pink Sheet" Oct. 29, p.3). Reflecting Kennedy's percolating interest in drug promotional practices, the senator devoted four questions to Kessler on advertising, marketing and promotional practices. The questions indicate as much about the direction of the inquirer (Kennedy) as they do about the preconceptions of the new regulator (Kessler). Kennedy's inquiry about increased legislative authority is perhaps most telling as a sign of one angle for Kennedy's interest in potential hearings during 1991. Kennedy's inquiry indicates that he may be considering hearings to build a case that current pharmaceutical promotion techniques stretch beyond the reach of FDA's existing regulatory authority. "Do you think," Kennedy asked, "that the requirements of the [FD&C] Act are sufficient to deal with the increasingly sophisticated promotional activities of the industry?" Kessler responded initially with praise for the breadth and latitude offered by the existing act. "Depending on the type of promotion, the provisions governing unapproved new drugs, adequate directions for use, and drug misbranding are very broad and should be sufficient to cover most situations." Kessler, however, diplomatically indicated his openness to Kennedy's complaints in the area. "I am committed," Kessler declared, "to vigorous enforcement in this area and will be sensitive to the need for enhanced statutory authority." Kessler does have three legislative changes to the FD&C mandate in mind as he takes over the job: subpoena authority, record inspection, and the presumption of interstate commerce (see box). Referring to his survey of the last year, Kennedy noted that "the committee [Labor & Human Resources] has been looking into the effects of advertising, marketing and promotional activities of the pharmaceutical industry on the prescribing habits of physicians and the cost of drugs." Kennedy maintained that the FDA effort in that area is undermanned, without a permanent director "for five years" and with only five employees. The senator asked for Kessler's views on the scope and resources of the existing FDA effort. "I have the impression," Kessler reponded, "that FDA has not moved as effectively as it might in this area [promotion and advertising regulation]." He observed that "traditional tools" for enforcement, such as recalls and seizures, may be inappropriate responses for promotional transgressions. The allocation of FDA resources to the policing of promotion, Kessler said, "must be addressed with the context of overall agency priorities." To a question on his attitude toward direct-to-consumer advertising, Kessler responded with a reference to his previous writings on this issue. Stating that FDA needs to "proceed cautiously" in this area, Kessler referred to his previous statement on the balance between the informational value of advertising and its ability to stimulate excess drug use. Interestingly, Kessler puts the confusion/overuse part of the equation first in his statement: "Public health needs should be considered when deciding what kind of advertising is permissible. Ultimately, the risks of overuse and consumer confusion need to be balanced against the benefits that can be achieved by informing the public about the existence of a specific therapy." FDA AUTHORITY; INCREASED MANDATE FROM KESSLER's VIEW The following suggestions for increased FDA authority are taken from David Kessler's answers to Sen. Kennedy prior to Kessler's confirmation as FDA commissioner on Oct. 27. "It is premature for me to make any judgment as to whether additional legislation is needed to buttress FDA's current enforcement authorities. However, I believe that there [are] at least three effective tools that FDA may need to have available -- direct subpoena authority; authority to inspect the records of manufacturers (which now exists only for prescription drugs and certain medical devices); and extending the presumption of interstate commerce to all FDA-regulated products."
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