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1 month ago | 
jdsupra.com | Shoshana Golden |Stephanie Trunk
There are currently six states with active Prescription Drug Affordability Boards (PDABs) — Colorado, Maryland, Washington, Oregon, New Hampshire, and Minnesota. As PDABs march toward declaring the price of certain drugs to be unaffordable for state residents and establishing a maximum price or reimbursement for certain drugs in their states, some pharmaceutical manufacturers have begun to challenge the constitutionality of PDABs in court.
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1 month ago | 
afslaw.com | Stephanie Trunk |Shoshana Golden
On As PDABs march toward declaring the price of certain drugs to be unaffordable for state residents and establishing a maximum price or reimbursement for certain drugs in their states, some pharmaceutical manufacturers have begun to challenge the constitutionality of PDABs in court. In March, a federal court in Colorado tossed out one of these suits on the basis that the manufacturer lacked the requisite standing.
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Jan 22, 2025 | 
jdsupra.com | Shoshana Golden |Dan Jasnow |Wayne Matelski
In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued two draft guidances on the use of artificial intelligence (AI) in the context of drugs, biologics, and medical devices.
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Jan 21, 2025 | 
afslaw.com | Dan Jasnow |Wayne Matelski |Shoshana Golden
In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued two draft guidances on the use of artificial intelligence (AI) in the context of drugs, biologics, and medical devices.
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Jan 6, 2025 | 
natlawreview.com | Shoshana Golden
Skip to main content January 06, 2025 Volume XV, Number 6 Legal Analysis. Expertly Written. Quickly Found.
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Jan 6, 2025 | 
afslaw.com | Shoshana Golden |Emily Leongini
On As you know, MoCRA was passed just over two years ago on December 29, 2022, and imposed extensive new requirements related to cosmetic products. We have covered those provisions at length across various alerts, which we have hyperlinked below. Now that it is officially 2025, we wanted to recap which MoCRA requirements have gone into effect and which are still yet to come.
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Nov 22, 2024 | 
jdsupra.com | Shoshana Golden |Stephanie Trunk
This past July, we reported on the Centers for Medicare & Medicaid Services (CMS) release of the 2025 proposed Hospital Outpatient Prospective Payment System (HOPPS) and Physician Fee Schedule (PFS) rules. CMS has now released the 2025 final rules, though they will not be published in the Federal Register for several more weeks. Our alert on CMS’ release can be found here. The HOPPS final rule can be found here, with a high-level summary in the CMS fact sheet available here.
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Nov 21, 2024 | 
afslaw.com | Stephanie Trunk |Shoshana Golden
Our alert on CMS’ release can be found here. The HOPPS final rule can be found here, with a high-level summary in the CMS fact sheet available here. The PFS final rule can be found here, with the companion CMS fact sheet available here. Both rules are effective January 1, 2025. Below is an overview of the relevant provisions for pharmaceutical manufacturers and the pharma community.
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Sep 4, 2024 | 
jdsupra.com | Shoshana Golden |Douglas Grimm |Gayland Hethcoat II
In 2021, we provided an overview of multiple federal lawsuits challenging the US Department of Health and Human Services (HHS) Health Resources and Services Administration’s (HRSA) enforcement of the 340B Drug Pricing Program, particularly with respect to contract pharmacies. Three years later, the “340B Saga” continues. Following the filing of new cases and developments in others, we are back with another update.
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Sep 3, 2024 | 
afslaw.com | Douglas Grimm |Stephanie Trunk |Shoshana Golden
On Drug Manufacturers Prevail on Appeal in Challenges to HRSA’s Efforts to Limit Contract Pharmacy ConditionsThe 340B Program provides certain health care organizations, referred to as “covered entities,” with access to discounted outpatient drugs from manufacturers. Many covered entities, lacking their own pharmacies, enter into agreements with outside pharmacies, or “contract pharmacies,” to dispense discounted drugs to patients.
