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

UsernamePublicRestriction
UsernamePublicRestriction

FDA BIOLOGICS CENTER IS TARGETING PROMOTION OF IND CLAIMS

Executive Summary

FDA BIOLOGICS CENTER IS TARGETING PROMOTION OF IND CLAIMS for drugs and unapproved use claims, Center for Biologics Evaluation and Research Vaccine & Therapeutic Products Branch Chief Sharon Risso told a Food & Drug Law Institute meeting on July 16. CBER intends to focus "on the most troublesome [promotional] activities," Risso said. "With biologics, this is with the promotion of investigational new drugs and the promotion of approved drugs for unapproved uses." Such promotion takes place "through [Securities & Exchange Commission] statements, through press releases, and through so-called scientific exchange seminars," Risso said. A second area of concern, Risso continued, is with "unsubstantiated comparative" claims. There are "very few instances where comparative claims are valid, unless they are based on the results of an adequately controlled clinical study which actually compared your product against your competitor's," she maintained. Comparative studies should "show statistical significance in the outcome parameters that the study was prospectively designed to measure." In response to a question, Risso said the "very few instances" where a comparative claim could be made without a study would include differences in structure or purity, but not differences in a drug's benefit to patients. Risso linked CBER's concern to an agency-wide trend. "It is an understatement to say that Commissioner Kessler is interested" in the promotions issue, Risso said. "All centers are involved." Kessler penned an article on promotional abuses in the July 18 issue of The New England Journal of Medicine in which he targets both promotion of unapproved products or indications and comparative claims ("The Pink Sheet" July 22, p. 16). Discussing the ad/promotion crackdown, Risso cautioned against thinking that CDER's advertising regulatory decisions do not apply to CBER. "For the most part, the regulation, the guidance on promotional materials and the policies that have been disseminated by the Center for Drugs are in fact totally applicable to biologics regulation," Risso told FDLI. CBER Office of Compliance Director Thomas Bozzo agreed with Risso that promotion of unapproved products is a leading "topical issue" confronting his office. He told the FDLI meeting that, as part of the agency-wide advertising enforcement initiative, criminal referrals for firms guilty of repeated mispromotions are "a possibility." In the past, Bozzo said, FDA has been willing only to refer cases of fraud to the Justice Department for prosecution. However, "the Center for Biologics and the agency at large have discovered that, in fact, there are some other cases that need to be referred also, because they represent continuing violations . . . [that] are representative of -- for lack of a better term -- a reckless disregard for the standard." Bozzo predicted that "we'll be seeing a number of criminal cases that are referred to the Department of Justice that will not have a fraud component to them."

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

UsernamePublicRestriction

Register

OM011381

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