PhRMA Urges FDA To Flesh Out Medicare Act Provisions On 180-Day Exclusivity

Law360, New York (May 7, 2004, 12:00 AM EDT) -- A trade group representing drug originators has urged the U.S. Food and Drug Administration to define key terms in the Medicare Prescription Drug Act’s patent reforms concerning 180-day marketing exclusivity.

The Pharmaceutical Research and Manufacturers of America (PhRMA) says the FDA should define the terms first applicant date certifications" and "lawfully maintained" to avoid speculative challenges of innovator patents and delayed generic drug competition.

Under the law, only generic drug applicants that meet the definition of a "first applicant" are eligible for 180-day exclusivity. That definition...
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