News & Analysis as of

Pharmaceutical Industry Medicare Federal Food Drug and Cosmetic Act (FFDCA)

Alston & Bird

Health Care Week in Review: HHS Finalizes Rule Prohibiting Disability Discrimination; FDA Finalizes LDT Rule; Senate Finance...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Alston & Bird

Health Care Week in Review: CMS Finalizes Rules on Nursing Home Staffing Standards and Medicaid Access and Quality; FTC Bans Most...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond

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As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Alston & Bird

Alston & Bird Health Care Week in Review - February 2022 #1

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

MoFo Life Sciences

Ninth Circuit Weighs In On Fraud-On-The-FDA Theory, Marketing Devices For Off-Label Use, And Kickbacks

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The Ninth Circuit recently weighed in on the appeal of a False Claims Act lawsuit from a relator against Medtronic. In this case, the relator alleges that Medtronic, Inc.: (1) Engaged in “fraud-on-the-FDA” when obtaining...more

Holland & Knight LLP

Healthcare Law Update: April 2021

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William F. Gould In United States v. Merino, No. 19-50291, 2021 WL 754589 (9th Cir. Feb. 26, 2021), the court of appeals reversed the conviction of Marina Merino of conspiracy to commit healthcare fraud in violation of 18...more

Holland & Knight LLP

Healthcare Law Update: April 2021

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William F. Gould In United States v. Merino, No. 19-50291, 2021 WL 754589 (9th Cir. Feb. 26, 2021), the court of appeals reversed the conviction of Marina Merino of conspiracy to commit healthcare fraud in violation of 18...more

Holland & Knight LLP

Court of Appeals Affirms Judgment that Struck Down Rule Mandating Price Disclosure in Pharmaceutical Ads

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Holland & Knight's July 2019 Healthcare Law Update reported on a decision by the U.S. District Court for the District of Columbia that struck down a final rule promulgated by the U.S. Department of Health and Human Services...more

King & Spalding

A Gimmick No More? HHS Moves to Authorize Prescription Drug Importation

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Since its enactment in 2003, Section 804 of the Federal Food, Drug, and Cosmetic Act (FDCA) has been a dead letter in the law. The provision authorizes the importation of certain prescription drugs from Canada, but only if...more

Holland & Knight LLP

Healthcare Law Update: July 2019

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CMS Regulation - District Court Strikes Down Rule Mandating Price Disclosure in DTC Pharmaceutical Advertisements - The U.S. Department of Health and Human Services (HHS), together with the Centers for Medicare &...more

Alston & Bird

Alston & Bird Healthcare Week in Review

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Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health...more

Patterson Belknap Webb & Tyler LLP

Second Circuit Declares Off-Label Promotion Ban Unconstitutional: Implications for False Claims Act Defendants

On December 3, 2012, the United States Court of Appeals for the Second Circuit held that the First Amendment protects pharmaceutical companies who truthfully promote the lawful, off-label use of prescription drugs from...more

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