Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

UsernamePublicRestriction

VANDERVEER GROUP DISTRIBUTING PHYSICIAN's GUIDE ON COMPANY- SPONSORED MEETINGS THAT OUTLINES DIFFERENCES BETWEEN MARKET RESEARCH, CME, PROMO MEETINGS

Executive Summary

The Vanderveer Group plans to distribute an internally developed guideline for physicians on company-sponsored meetings that defines the boundaries between meetings designed for market research, product promotion, and physician clinical education. In a statement accompanying the guidelines, Vanderveer acknowledges that "there has been a great deal of confusion lately regarding physician participation in meetings sponsored by pharmaceutical companies." Each type of meeting has a "specific intent or purpose," and "different guidelines apply" concerning meeting content and gifts to physicians, Vanderveer advises. In market research, for example, physicians can receive fees when they assist firms by answering questions on their practice of medicine. The American Medical Association, in a Sept. 26 letter, said the Vanderveer statement "accurately reflects" ethical guidelines put forth by AMA to govern industry-physician contacts ("The Pink Sheet" Sept. 30, T&G-3). The Vanderveer Group also submitted a copy of the statement to FDA and requested an agency review. FDA responded that it would be unable to comment. The agency may not have wanted to issue an official comment in advance of its own forthcoming guideline on industry-sponsored scientific symposia, which is expected to be released in draft form the week of Oct. 7- 11. Vanderveer plans to enclose the statement in all mailings and invitations to meetings that it sends to physicians. The firm estimates that it contacts approximately 25,000 physicians a year. It also plans to run the statement in a one-page advertisement in a late October issue of the New England Journal of Medicine. Vanderveer said it will require meeting moderators to point out the statement at the start of every meeting put on by the firm. A Vanderveer spokesperson said the firm has not seen a decline in physician participation in meetings but decided to draft the statement after a number of doctors expressed both confusion about their responsibilities regarding sponsored meetings and a lack of understanding of the differences between the three types of meetings other than whether a fee is involved. Vanderveer's "physician's guide" notes that the objective of marketing research meetings "is to answer specific questions that will help companies make better business decisions." The statement notes that "information is collected" at such meetings "regarding the way physicians practice medicine and their opinions of current and new drugs" and that they often occur at a marketing research facility "equipped with a one-way mirror to permit direct observation by researchers." Physicians may receive an "honorarium for their consulting services" and such "fees are accepted practice and are fully within the current AMA guidelines," the Vanderveer document says. Vanderveer said its market research code of principles directs that fees be "on a scale appropriate to [physicians'] involvement in the study." Fees should be less, for example, for a one-hour interview than for participation in a two-hour focus group. Promotional meetings are used to "promote a product to physicians," the statement advises. "They can be considered a supplement to the company's sales representatives and as such, all discussions at promotional meetings must be framed within the product's FDA-approved package insert. Programs are often held at hotels and restaurants and may include a modest meal," but not cash honoraria. Educational meetings are "non-commercial, issue-oriented sessions about a disease state or therapeutic area," the document continues. "The key focus . . . is an objective, balanced presentation of information without emphasis on any particular product." While continuing medical education credit "is typically offered," the "knowledge gained is the only incentive offered to participation."

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

Latest Headlines
See All
UsernamePublicRestriction

Register

PS019861

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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

Cancel