To: NATIONAL EDITORS
Contact: Michael Levin-Epstein, Editor-in-Chief of FDLI, +1-202- 222-0897, [email protected]
WASHINGTON, Sept. 17 /PRNewswire-USNewswire/ — More than ever, physicians in the United States are prescribing drugs, biologics and devices to treat patients in ways that were not specifically approved by FDA. This treatment often is in response to patients’ increasing demand for access to drugs and devices that promise hope for treating diseases but that have not yet been approved by FDA for such uses.
There’s nothing illegal about this practice by physicians. But FDA rigorously regulates off-label communication, promotion and marketing by pharmaceutical, medical device and biotechnology firms. The bottom line: Although patients may use and physicians may prescribe off-label, manufacturers and distributors may not promote off-label except under the narrowest of circumstances.
Under the current federal regulatory scheme, the promotion of a product for a use that does not appear on the product’s labeling renders the product itself “misbranded,” and the adding of an unapproved use to the products labeling makes the product “adulterated.” Manufacturing, delivering, receiving, or introducing a medical product into the interstate commerce that is “misbranded” or “adulterated” is unlawful under federal law. Such conduct exposes the violator to injunction, product seizure, debarment, fines, civil penalties, and imprisonment. Criminal enforcement of these laws has been increasing at both the state and federal level.
FDA is still finalizing guidance in this area, especially on the issue of distributing journal articles describing off-label indications. So, experts concluded at the Food and Drug Law Institute’s annual Advertising and Promotion Conference in Washington, D.C., Sept. 9, companies should watch their step to avoid investigations that could lead to fines or even criminal prosecution.
Now, for the first time, the Food and Drug Law Institute (FDLI) has published a comprehensive guide for pharmaceutical firms, medical device companies, life science attorneys, sales and marketing staff, compliance officers, regulatory affairs specialists and consultants on how to comply with FDA regulations on off-label communications.
The 217-page book, Off-Label Communications: A Guide to Sales and Marketing Compliance,edited by Mark Carlisle Levy, a partner at Saul Ewing, LLP and Co-Chair of its Life Sciences Practice Group, in Philadelphia, PA, discusses specific problems arising from off- label use and promotion, while providing practical instruction on how to deal with them, including managing clinical trial disclosures; reimbursement; training and monitoring sales and marketing representatives; risk management; product liability litigation; ethical considerations and how the government is enforcing off-label sales and marketing compliance.
For more information about the book, visitwww.fdli.org.
Media:To obtain a review copy of Off-Label Communications: A Guide to Sales and Marketing Compliance,contact Michael Levin- Epstein, Editor-in-Chief, FDLI, (202) 222-0897; [email protected].
Founded in 1949, FDLI publishes the award-winning, peer-reviewed Food and Drug Law Journal;the bimonthly magazine Update; FDA Directory;and dozens of books and publications for attorneys, regulatory affairs practitioners, scientists, health care professionals, government employees and marketers in the food and drug field. For more information, visit www.fdli.org
SOURCE Food and Drug Law Institute
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