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

GPIA INACTIVE INGREDIENT LABELING GUIDELINES EXCLUDE FROM TRADE SECRET

Executive Summary

GPIA INACTIVE INGREDIENT LABELING GUIDELINES EXCLUDE FROM TRADE SECRET exemption substances that can be identified by "modern analytical technology." The Generic Pharmceutical Industry Assn. (GPIA) guides, which the assn. submitted to FDA on July 29, state that an inactive ingredient need not be disclosed on Rx drug labeling "if its presence gives the mfr. an advantage over competitors who do not know or use it and if the identity of the ingredient cannot be determined by using modern analytica. technology." In a letter addressed to FDA Drugs & Biologics Center Director Meyer and attached to the guidelines, GPIA President Dee Fensterer cited the trade secret exemption as an illustration that the generic assn.'s guides are more stringent than those issued by the Pharmaceutical Mfrs. Assn. (PMA). "Although patterned after the labeling guidelines issued by the PMA, the voluntary guidelines adopted by our members are in some respects stronger or more explicit." Fensterer added that GPIA members "have already begun the process of revising their package inserts" so that "all Rx products packaged after Dec. 31, 1985 will be in full compliance" with the guidelines. In the filing, the assn. also asked FDA's aid in combatting what it called an "intensifying" antigeneric campaign by the brandname industry. Fensterer asked Meyer to consider launching "an active FDA program that informs the medical profession of the FDA standards for approving the inactive, as well as the active, ingredients of bioequivalent generic drugs." The campaign "questions the FDA's ability to assure the safety of inactive ingredients and the therapeutic equivalence of generic drugs," Fensterer said. GPIA sent same-day letters to Rep. Waxman (D-Calif.) and Sen. Hatch (R-Utah), coauthors of the post-1962 ANDA/patent extension law, to ask their help in stopping negative campaigning. "We believe the FDA must affirmatively address this challenge to its own regulatory standards, and we would welcome your assistance in this effort," the assn. said.

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

PS008736

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