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

TREATMENT IND EDUCATIONAL MATERIALS: PRECLEARANCE WITH FDA advised by FDAer Sharon Risso at a Jan. 30 Food and Drug Law Institute seminar on the promotion and advertising of biologics. Risso works in the Center for Biologics Evaluation and Research's Division of Product Certification as chief of the Vaccines & Therapeutic Products Branch. "For those companies that hold Treatment INDs, we for the most part have looked at...the physicians' brochures, informed consents, and patient instruction information" prior to distribution, Risso observed. CBER is coordinating with its counterpart in drug evaluation (CDER) "very carefully" on the issue, Risso added. "Both groups are trying to develop a policy where we could disseminate informal guidance on Treatment INDs." Treatment INDs raise questions for the agency's advertising regulators, Risso indicated, because the process of encouraging physician and patient participation may "muddy the water a bit when it comes to...interpreting the basic prohibition that 'thou shall not promote' [products for unapproved uses]." "Make it clear to everyone, including the sales force, that this is an investigational product," Risso advised. "Make no claims about safety and efficacy. The safety and efficacy data that you submitted to the agency to support the approval of your Treatment IND should be used as a basis for defining benefit versus risk to the patient population that you are approved to treat -- and nothing more," Risso declared. Risso also stressed that companies with Treatment INDs underway "must be careful about where those informational items are need to direct this information to the specific patient population for which the Treatment IND was approved. A very general, unrestricted informational piece will require extreme due diligence on the part of the company to assure us that it is not being disseminated to other patient population areas."

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

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