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How to Tackle Pharma’s 3 Biggest Compliance Risks Head-On with Verisys

Verisys

Verisys’ former VP of Pharma and Pharmacy Solutions, Joe Thompson, shared a prime example of how speaker programs introduce risk to the pharmaceutical company: “In 2011, one of the most prominent endocrinologists in my sales region was an active speaker for my previous company. He led multiple programs for us each year.

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President Biden Signs End-of-Year Legislation Including Telehealth, Medicare & Medicaid, Mental Health, Pandemic Preparedness, and Other Health Care Provisions

C&M Health Law

trillion spending package, which consists of all 12 fiscal year (FY) 2023 appropriations bills and funds the federal government through September 30, 2023, provides additional assistance to Ukraine, and makes numerous health care policy changes. 117-164 ) (the “Act”)—an approximately $1.7

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CMS BLOG: Medicare for All? Just another name for a government-run, single payer system

CMS.gov

Just another name for a government-run, single payer system. Just another name for a government-run, single payer system. As head of the agency that serves over 58 million Medicare beneficiaries, I deal first-hand with the challenges of government run healthcare. percent from 2011-2016, from $17.6 keya.joy-bush@….

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An Abuse of Discretion So Vast….  Our Long-Delayed Critique of the Valsartan MDL Class Action Certifications

Drug & Device Law

These class certifications combined 428 different pharmaceutical products, produced and marketed by 28 separate defendants, with claims governed by the laws of 52 separate jurisdictions. A procedural rule, such as Rule 23 governing class actions, should not, and legally cannot , change that result. Valsartan , 2023 WL 1818922, at *24.

FDA 59
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Terrible Decision Contravenes the Vaccine Act’s Purpose and Would Gut Its Protections

Drug & Device Law

223, 231-33 (2011), holding that the Vaccine Act preempted all design defect claims asserted by claimants who rejected Vaccine Act awards and sought to litigate their claims instead. The Supreme Court did its part in Bruesewitz v. Wyeth LLC , 562 U.S. Now comes DeCostanzo v. that they would not have received otherwise.” 300aa-11(a)(2)(a).

FDA 115
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The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

2023) (federal government may unilaterally obtain dismissal of FCA claims, and calling the constitutionality of the FCA’s private enforcement mechanism into question) ( here ); Quishenberry v. 2023) ( Buckman preemption barred MDL asserting fraud on EPA), cert. In 2023, these include United States ex rel. Polansky v. 3d 239 (Cal.

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Agree To Disagree – Don’t  Sue the Other Side of a Scientific Dispute into Silence

Drug & Device Law

Criticizing attempts to sue publishers of scientific content, here in 2011, and again, here in 2013. Scientific literature about the risks and benefits of prescription medical products does not – at least in the absence of academic fraud such as the actual falsification of data (see, here ) – subject the speaker to tort liability.