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

THERAPEUTIC EQUIVALENCE RATING IN FDA's "ORANGE BOOK" does not affect the rights of a mfr. or reflect on a product, attorney Jonah Shacknai (D.C. firm Royer, Shacknai & Mehle) stated in a supplement to a citizen petition filed by the firm in January. Shacknai said comments submitted to FDA by the Generic Pharmaceutical Industry Assn. (GPIA) and Forest reflect a "fundamental misunderstanding" of the petition. Shacknai asserted that the petition requests merely "that FDA not rate as 'therapeutically equivalent' any two drugs which do not meet the 'sameness' requirement of the [Waxman/Hatch] Act (e.g., drugs whose labeling differences are not among those permitted under the 1984 Act for drugs which are otherwise the 'same' as the listed drug) and, in the case of post-1984 ANDA'd drugs, approve such drugs under an ANDA only if they have first been the subject of an ANDA-suitability petition." Shacknai stated that "the presence or absence of a 'therapeutic equivalence' rating in the "Orange Book" affects no rights of any mfr. Nor would a change in a 'therapeutic equivalence' rating, e.g., from an 'A' rating ('therapeutically equivalent') to a 'B' rating ('not therapeutically equivalent') or the elimination of a product's rating altogether even reflect adversely on the product." However, Shacknai added, by ensuring that "drugs whose conditions of use differ from one another not be rated 'therapeutically equivalent,'" FDA "would help avoid the significant adverse reactions and thereapeutic failures that may occur when drugs are substituted for each other for conditions for which they are not 'therapeutically equivalent.'" GPIA argued that the Waxman/Hatch law's definition of bioequivalence recognized that there may be situations where the generic drug and "listed" drug are equivalent despite labeling differences. Shacknai responded that the Act "reserves the ANDA-suitability petition procedure for drugs which are materially different from the listed drug." He said "under current FDA practice such drugs would not be rated in the Orange Book as 'therapeutically equivalent' to the listed drug." In its comments, Forest maintained that the addition of a once-a-day dosage regimen to Key's Theo-Dur should not alter the therapeutic equivalence rating of Forest's Theochron that was designated by FDA in 1983. Shacknai said "the time at which a rating was granted a drug -- pre-1984 Act vs. post-1984 Act -- has no bearing on the question whether it is 'pharmaceutically equivalent' and 'bioequivalent' to another drug; nor does the existence or non-existence of another drug which might or might not be termed a 'listed' drug; nor does the time at which a new dosing schedule was approved for one of the two drugs; nor does the size of the market for the drug with the new dosing schedule."

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