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

ELECTRONIC "ORANGE BOOK" BEING CONSIDERED BY FDA

Executive Summary

ELECTRONIC "ORANGE BOOK" BEING CONSIDERED BY FDA, Center for Drug Evaluation and Research Director Carl Peck, MD, told a Sept. 19 agency-sponsored conference on ways to make the publication both more useful and more useable. "We see a day when the agency will be working in the mode of electronic transfer as the primary mode of communication. We would like your counsel on the advisability of developing a long-term strategy for moving the "Orange Book" in that direction as well." Issues include the receptiveness of practitioners to electronic delivery, and the method of delivery, such as optical disc versus an online database, he said. Subsequent speakers welcomed the electronic delivery idea. For example, American Pharmaceutical Association Senior Director for Pharmacy Affairs Arthur Kibbe, PhD, said the association has had "tremendous success" with monthly updates of drug interaction data provided on computer discs. "If the formating problems with the "Orange Book" could be corrected, pharmacists , at least the goodly portion of them that have [personal computers],...could add the "Orange Book" to their PC and have it as a reference," Kibbe predicted. "It would require, however, some software implementation so that information would be called immediately to hand." He advised against an electronic bulletin board approach, due to the number of phone lines and computer equipment that would be required for adequate accessibility, particularly given the percentage of 160,000 pharmacies in the U.S. that might want to participate. The "Orange Book," formally entitled Approved Drug Products With Therapeutic Equivalence Evaluations, is also used by FDA as the vehicle to publish patent expiration dates as directed by the 1984 Waxman/Hatch law. FDA Associate Commissioner for Health Affairs Nightingale, MD, said the agency has been "disappointed" that the book is not in wider use, despite articles in medical and pharmacy journals and other strategies to publicize its availability. A recent Government Printing Office review indicated there are about 4,000 subscriptions, which include the yearly compendium and monthly updates. The United States Pharmacopeial Convention agreed to try to make much of the "Orange Book" data available at a lower price in a publication of its own, and to date has "more than doubled" GPO's distribution, USP Executive Director Jerry Halperin said. A USP publication entitled USP DI, vol. 3 contains information drawn from the "Orange Book" plus abstracted USP monographs and certain information on good manufacturing practices and recalls. The price of the USP book is $69 dollars per year, with a $10 discount for subscribers to other USP publications, versus $91 for the "Orange Book," he said. Suggestions offered by meeting attendees for improving the "Orange Book" included using more readable typeface and section heads; providing abridged versions targeted at special audiences; eliminating listings of single-source drugs; adding a list of pre-1938 drugs, which are not now in the "Orange Book"; adding the dates that therapeutic equivalency evaluations were conducted and decision criteria; providing a concise list of drugs not judged therapeutically equivalent; making it easier to find combination products under each of their active ingredients; and providing information about treatment IND drugs. Several speakers also called for information designating the actual manufacturer of a drug product. The "Orange Book" lists only the NDA or ANDA holder. Nightingale noted the agency is working on a regulation to require tablets to be imprinted with information identifying the manufacturer ("The Pink Sheet" Feb. 6, 1989, T&G-13).

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

PS018104

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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