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FTC asks generic drug firms for data for study

WASHINGTON
Fri Dec 21, 2007 2:20pm EST

WASHINGTON (Reuters) - The U.S. Federal Trade Commission asked generic drug manufacturers for prices, cost data and sales information to help study the short- and long-term effects of authorized generics on prescription drug competition, the agency said on Friday.

U.S.

The new set of information requests to generic drug makers follows a similar request to branded drug companies, the FTC said in a statement.

Generic drugs are copies of brand-name drugs that generally cost less. A U.S. law allows, in certain circumstances, the first-filing generic competitor of a branded drug to be sold during a 180-day exclusivity period before the patent expiration of the brand-name drug.

However, that provision does not bar competition from "authorized generic" drugs that have an approved new drug application on file with the U.S. Food and Drug Administration.

In recent years, brand-name drugmakers have begun selling authorized generics at exactly the same time the generic first-filer drug is beginning its 180-day exclusive marketing period, leading to questions about effects on competition.

In March 2006, the FTC began studying the marketing of authorized generic drugs by or on behalf of branded drug companies following a request from several U.S. lawmakers. The agency said it planned to subpoena, if necessary, information for the study from 80 brand-name drug companies, 10 authorized generic makers and 100 independent generic manufacturers.

A list of the information sought by the FTC from authorized generic drug makers was posted on the agency's Web site at: here

(Reporting by Julie Vorman, editing by Richard Chang)



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