Implications of Regulatory Policies on Off-Label Uses for Industry Competitiveness
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Drug 1nforma:ion J o u m / . Vol. 32, pp. 379-381, 1998 Printed in the USA. All rights reserved.
IMPLICATIONS OF REGULATORY POLICIES ON OFF-LABEL USES FOR INDUSTRY COMPETITIVENESS NICHOLASL. RUGGIERI, JD Serono Laboratories, Inc., Rockville, Maryland
Regulatory policy with regard to off-label uses is discussed from the perspective of a research and development-oriented pharmaceutical manufacturer. Opening up the policy on dissemination of information on 08-label uses will affect incentives to go ajier orphanspecific labeling and poses an issue for industry competitiveness because multiple sponsors for the same drug with different indications can benejit from the work of the first sponsor. When opening up dissemination, strict guidelines must be employed to preserve incentives for research that will benefit patient populations being targeted. Key Words: Off-label uses; Industry Competitiveness: Research
THIS PAPER HIGHLIGHTS some of the issues from the perspective of an intensively research and development-orientedmanufacturer such as Serono Labs. The current Food and Drug Administration policy is no promotion of off-label indications. There is some liberalization of the promotion policy within the context of scientific exchange. This does not mean that manufacturers can go out and promote off-label uses; however, if an offlabel use comes up in the context of a scientific discussion of an approved use, manufacturers are not prevented from participating in that discussion. That is an important point to keep in mind, otherwise the general rule allows dissemination of off-label information on request only. Guidance is derived from the Code of Federal Regulations, Parts 201
and 202, as far as advertising and promotion rules are concerned. What exactly is occurring at this point that is supposedly going to change all of this? One thing is the so-called “Mack-Frist” legislation which was introduced in 1996 in Congress and was discussed extensively again in 1997, but as yet has not found its way into the FDA reform and the Prescription Drug User Fact Act (PDUFA) reauthorization bill. Essentially, the concept is very simple. It would open up the off-label promotion policy to allow a manufacturer to disseminate peerreviewed literature and medical texts that meet some very elaborate criteria spelled out in the legislation. No prior requests from providers would be required so manufacturers would be at liberty to disseminate literature freely. The FDA would continue to maintain some control over content, at least to the Presented at the DIA 33rd Annual Meeting “Optimizing extent of requiring balance in the informaPharmaceutical Development: The Global Experience,” tion. If there is an imbalance in the material June 22-26. 1997, Montreal, Canada. Reprint address: Nicholas L. Ruggieri, JD, Serono favoring the off-label use, and there is other Laboratories, Inc., 1700 Rockville Pike, Suite 210, literature out there that presents differing opinion on the off-label use, then FDA can Rockville, MD 20852. 3 79
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