Pharma Forum Dialogues

Court Decision Clarifies Hatch-Waxman Data Exclusivity

Posted by New York Pharma Forum Inc. on Jul 30, 2015 2:00:00 PM

By: Clark G. Sullivan and Sujatha VathyamTroutman Sanders LLP

A pharmaceutical patent lawsuit against the Food and Drug Administration (“FDA”) earlier this year has clarified when 3-year Hatch-Waxman data exclusivity will prevent the United States Food and Drug Administration (“FDA”) from approving an application filed under section 505(b)(2) of the Food Drug and Cosmetic Act (the “FD&C Act”). In the case, Veloxis Pharmaceuticals, Inc. v. FDA, a United States District Court held that reliance on an earlier approval was not necessary for three year data exclusivity to delay the later filed 505(b)(2) application. Exclusivity arose solely because the later application was for the same drug as the earlier approval and would be approved for the same conditions of use.

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Topics: Hatch-Waxman Litigation, patent law, FDA guidance

Two FDA Citizen Petitions Granted Regarding Manufacturer Speech

Posted by New York Pharma Forum Inc. on Aug 1, 2014 3:08:00 PM

By Al Cacozza and Sarah Blankstein, Ropes & Gray

On June 6, 2014, the Food and Drug Administration (“FDA”) issued a response granting the two pending FDA citizen petitions[1] filed by members of the Medical Information Working Group (“MIWG”), an ad hoc coalition of drug and device manufacturers to which Ropes & Gray LLP serves as one of the outside counsel. This response reflects the agency’s on-going effort to clarify its regulatory approach regarding manufacturer communication of scientific and medical information to health care professionals (“HCPs”). This post summarizes the key aspects and implications of that response.

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Topics: FDA guidance

FDA Releases Draft Guidance on New Risk Information for Approved Drugs

Posted by New York Pharma Forum Inc. on Jul 16, 2014 5:07:00 PM

By Al Cacozza and Sarah Blankstein, Ropes & Gray

On June 6, 2014, the Food and Drug Administration (“FDA”) issued a draft guidance on new risk information for approved drugs. The document is entitled “Guidance for Industry: Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products—Recommended Practices.”  This post summarizes the key aspects of that document.

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Topics: FDA guidance

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