The Pharmaceutical Research and Manufacturers of America (PhRMA) – a leading lobbying and advocacy group for drug manufacturers – has released an updated version of its “Code on Interactions with Health Care Professionals” (the PhRMA Code or the Code).
Hospitals have long used color-coded wristbands as a patient safety initiative. Recently, the FDA issued a letter to medical device manufacturers to caution them against using colors for device identification wristbands that could create confusion for clinicians and result in inappropriate medical
CMS has released a proposed rule (the Proposed Rule) which, if finalized and adopted, would rescind the Trump Administration’s attempt to align reimbursement under Medicare Part B for certain drugs with benchmark pricing obtained from surveys of other countries.
The Centers for Medicare & Medicaid Services (CMS) has issued its annual proposed rule related to the Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems (HOPPS) (the Proposed Rule). Comments on the Proposed Rule are due no later than September 17, 2021.
Since no COVID-19 vaccines have been granted regular FDA approval, the United States Department of Justice sought to clarify whether the vaccines’ EUA status prohibits the imposition of such requirements.
The Centers for Medicare & Medicaid Services (CMS) calendar year 2022 rule proposing changes to payment policies under the Physician Fee Schedule (PFS) and Medicare Part B (the Proposed Rule) will officially be published in the Federal Register on July 23, 2021.
The United States Supreme Court has agreed to hear a case that has a direct impact on the 340B Drug Discount Program (the 340B Program) and how Medicare will reimburse hospitals for dispensing of 340B covered drugs, as well as other reimbursement issues.
On February 24, 2021, we first reported on the most significant variants of the novel coronavirus then emerging across the globe and here in the United States.
In July 2020, the Trump Administration issued an Executive Order (the EO) directing the Secretary of the Department of Health and Human Services (HHS) to take certain actions and finalize rulemakings designed to “support the goal of safe importation of prescription drugs.”
On May 24, 2021, the US District Court for the District of New Jersey awarded Arent Fox client Sabinsa Corporation a total of $1,004,659.93 in attorney’s fees and costs as a sanction against Prakruti Products.
The United States Tax Court on April 27, 2021, ruled that Mylan Inc. could deduct the legal fees it incurred in defending itself against patent infringement claims made by other drug manufacturers while pursuing generic pharmaceutical drug applications.
We have seen biopharmaceutical companies around the world working to tackle COVID-19 in vaccine development, treatment development, and diagnostics, including the creation of world-class vaccines in record time, rapid tests for home use, and effective treatments against this novel virus.
Congress recently passed two bills that are designed to educate patients and prescribers about biosimilars and thereby encourage their use and to close a loophole in existing law that allows certain branded drugs to retain longer market exclusivity.
Decision highlights the need for applicants to focus on additional improvements to technology when drafting and prosecuting applications directed to computer-implemented diagnostics methods.
With COVID-19 vaccinations increasing, interest has grown in developing COVID-19 passports, digitized verification that the bearer has been fully inoculated against the virus. Last week, however, Florida Governor Ron DeSantis issued an Executive Order banning them in his state.