Drugs

FTC Complaint Against Shire Dismissed

Delaware federal court judge Richard Andrews has granted a Shire motion to dismiss a 2/7/17 Federal Trade Commission (FTC) complaint alleging that the company abused the FDA citizen petition process to prevent generic competition to its Vancocin. FTC said Shire “inundated” FDA with 46 regulatory and court filings that “harmed competition and consumer welfare by obstructing and delaying the FDA approval process for a generic version of Vancocin.”

Andrews says Shire made two main arguments in calling for dismissal. First, Shire said that FTC failed to plead the facts necessary to invoke its authority under the FTC Act to bring suit. And second, it said its actions are immune from challenge under the Noerr-Pennington doctrine, which says that entities have a right to petition the government for redress of grievances.

The ruling says Shire raised what appear to be novel questions about the interpretation of Section 13 of the FTC Act. The judge held that FTC’s ability to seek an injunction in the case rested on the agency’s ability to demonstrate that the company had violated or was about to violate a law that FDA enforces. He further held there was no dispute that FTC had not alleged that Shire was violating a law.

“Having accepted the complaint’s factual allegations as true and having viewed those allegations in the light most favorable to the FTC,” Andrews wrote, “I find the complaint fails to adequately plead facts allowing for the reasonable inference that [Shire] ViroPharma is ‘about to violate’ a law enforced by the FTC pursuant to Section 13(b).”

Andrews further determined that the question of whether the company’s petitions and other filings were a sham could not be determined at the motion-to-dismiss stage, and instead requires fact-finding. He gave FTC 20 days to revise its complaint in accordance with the dismissal order.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome