Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By



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.

You may also be interested in...

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts