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BRISTOL ONCOLOGY PROMOTIONS WILL BE PRECLEARED BY FDA FOR TWO YEARS: AUTOMATIC GO-AHEAD MAY PROTECT COMPANY FROM DELAYS IN AGENCY AD REVIEWS

Executive Summary

FDA's preclearance plan for Bristol-Myers Oncology promotional materials commits the agency to a 10-day review period for the company's submissions and an automatic go-ahead for the company if it does not hear otherwise from the agency. Summarizing the preclearance agreement in a May 17 letter to the company, FDA said it "would agree to review submitted materials within 10 days of receipt." The company would then "be free to disseminate the materials in question if you did not receive from FDA an objection or request for extension in that time." The promotional preclearance agreement is a centerpiece of FDA's corrective action agreement with Bristol-Myers Squibb regarding oncologoic drugs promotional practices and the sole- sponsored publication, "Oncology Commentary '90." Agency sources have been quoted as touting the preclearance agreement as the broadest and most intense arrangement of its type. Bristol-Myers Oncology has about a dozen products which will be covered by the agreement. The company will submit its promotional pieces to FDA for two years. The ad preclearance agreement, however, is not atypical. The agency has extracted similar agreements in recent years. In 1990, for example, FDA got Wyeth-Ayerst to agree to submit all promotional materials for Cordarone (amiodarone) for six months ("The Pink Sheet" April 2, 1990, p. 12). What appears to be unusual is the attention FDA is putting into getting out the word about its agreement with Bristol (see related story, p. 4). FDA has built into its agreement withe Bristol reasonable protections to make sure that its ad division does not spend all of its time overseeing one company's promotional pieces. There is, for example, a phrase in the agreement which will permit FDA to exclude certain types of material from review. Bristol-Myers Oncology has agreed to "submit to FDA for preclearance for a period of two years all potentially promotional materials disseminated by your company on its oncology products, with the exception of any categories of materials mutually agreed upon by you and FDA" [emphasis added]. The company has pressed FDA for an exclusion for some types of materials, such as the full text of symposia or material prepared by NCI or other independent authorities. FDA and the company have not worked out a clear definition of the types of materials which may be excluded. The company is trying to arrange a meeting with FDA to pursue the subject. "You requested a meeting with the Division of Drug Marketing, Advertising, and Communications," FDA's Ann Witt noted in the May 17 letter. One of the subjects of the meeting would be "to determine whether there are any categories of activities you fund or materials that you disseminate on your oncology products that need not be submitted for preclearance." The promotion of oncology products is a problematic area for FDA regulation. Because of the heavy off-label use of products in that field, Bristol claims there is real pressure from clinicians for up-to-date information on new uses. Those uses are most often unapproved uses and technically within the scope of FDA's jurisdiction. In the discussions on the "Oncology Commentary" publication, Bristol and FDA referred several times to trying to develop guidelines for distinguishing between scientific information and promotion in the oncologic drugs field. FDAer Witt told the firm that the agency would welcome comments on "an appropriate forum" for discussing the subject. One of the interesting sidelights to watch as FDA policies the dissemination of product information in the oncology area will be the reaction of the National Cancer Institute. FDA and NCI have been improving relationships over the last several years, but charges that NCI studies or reports may be serving the promotional purposes of a specific company could trigger another round of tensions. Similarly, restrictions on the distribution of information about new cancer drug regimens could have the same effect.
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