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Monthly Round-Up of What to Read on Pharma Law and Policy

Bill of Health

The selections feature topics ranging from a discussion of potential pathways to enable government patent use before nonpatent exclusivities expire, to an examination of medical oncologists who receive more than $100,000 annually from pharmaceutical companies, to an analysis of the launch prices of new drugs from 2008-2021. JAMA Intern Med.

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Biosafety Labs, Public Safety, and Politics

Bill of Health

dollars (USD) and additional government losses at $11 billion USD due to controlling livestock movement and depopulating infected livestock. The selection of the site was questioned by the Government Accountability Office. Or perhaps the site decision itself was an afterthought. By November of 2008, a new President was elected.

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D.C. Court of Appeals Joins Prohibition on Pro Se Pursuit of FCA Claims

Hall Render

government for false or fraudulent claims submitted for federal reimbursement. Because FCA relators pursue the governments claims, several circuits have determined this precludes relators from proceeding pro se. The government declined to intervene and, in a filing with the U.S. 2004); and United States v. Rockefeller v.

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HHS Shares Information on Advanced Persistent Threat Groups Linked with the Russian Intelligence Services

HIPAA Journal

Turla, aka Venomous Bear/Iron Hunter/KRYPTON/Waterbug, operates under the direction of the FSB and mostly targets industries such as academic, energy, government, military, telecommunications, research, pharmaceutical companies, and foreign embassies, and has been active since at least 2004. Mitigations.

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Is a Federal Medical License Constitutional?

Bill of Health

Some scholars have interpreted this to mean that the federal government has the right under the Commerce Clause to regulate all medical licensure. Gupta cites the Dormant Commerce Clause doctrine, a court-invented principle which allows the federal government to strike down state laws deemed excessively burdensome to interstate trade.

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The Health Insurance Premium for a Family Averages $25,572 in 2024 – KFF’s Annual Update on Employer-Sponsored Benefits

Health Populi

Prescription drugs (and costs) are on the minds of policymakers and legislators as well as prescribers, pharma companies, and payers — employers, government plans, health insurers and, of course, patients who co-pay or c0-share the costs of medicines. In 2024, the average patient share amounts are shown in Figure 9.6

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The Government Seeks FCA Liability for Off-Label Use of Medical Devices

Healthcare Law Blog

is a reminder that the government will use the FCA to target medical device manufacturers for off-label use of medical devices, even where healthcare providers have decided the use is safe and effective. The government is attempting to prove materiality using Medicare’s coverage requirement that procedures must be “reasonable and necessary.”