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Amarin, FDA Work Toward Settlement In Off-Label Promotion Case

A federal circuit court judge agreed Monday (Aug. 31) to give Amarin Pharma Inc. and FDA until the end of October to come up with a settlement in a high-profile case that gave the manufacturer wide latitude to promote its triglyceride-lowering drug Vascepa off-label.

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Sandoz pushed back against Amgen's “emergency motion” to block the biosimilar sponsor from bringing its filgrastim product Zarxio to market on Sept. 3, saying in court documents Monday (Aug. 31) that a further marketing delay would cause cancer patients significant harm.

Novartis' biosimilar company Sandoz urged FDA to reject "in its entirety" AbbVie's citizen petition asking the agency to require that biosimilar drug labeling contain a clear statement that the product is a biosimilar and that it is licensed for fewer than all the reference product's conditions, among other requests.

CMS is asking qualified health plans (QHPs) that have risk corridor data discrepancies when compared to other sources to fill out a “Risk Corridor Discrepancy Worksheet” to explain the differences and provide supporting documentation.

Food stakeholders can expect the preventive controls rules for human and animal food to come out soon as FDA announced Monday (Aug. 31) that it has submitted the final version of the regulations to the Federal Register, in accordance to a court-mandated deadline.

FDA rejected suggestions by lawmakers that the agency may be timing its publication of untitled letters describing inspection observations to affect the market or drive regulatory policy, writing to lawmakers that agency centers have different policies on which untitled letters are made public but in all cases their publication is merely used to communicate inspection observations that fall below the threshold of a warning letter.

CMS says the latest round of thorough ICD-10 testing, which was completed in July, showed that the agency is ready to accept and process ICD-10 claims come October.

Lawyers on both sides of U.S. House of Representatives v. Burwell are sparring over whether federal district court Judge Rosemary Collyer should grant a motion to strike what the plaintiffs believe was an “unauthorized” response from defendants to their notice of new supplemental authority filed June 30.

Lobbyists say the Senate Health, Education, Labor and Pensions Committee is considering introducing changes to FDA policy and electronic health records improvements in separate bills, rather than including both in one draft of the committee's Innovation for Healthier Americans legislation.