Lanton Law Blog

Learn about the latest trends and activities through our blog posts.

Posts in life sciences
FDA Proposes Rule Impacting Wholesale Drug Distributors & 3rd Party Logistics Providers

According to the Food and Drug Administration proposed rule, the (FDA) is “proposing national standards for the licensing of prescription drug wholesale distributors (“wholesale distributors” or “wholesale drug distributors”) and third-party logistics providers (“3PLs”), as directed under the Drug Supply Chain Security Act (DSCSA) (Title II of the Drug Quality and Security Act). Pursuant to the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the DSCSA, the proposed rule would establish standards for all State and Federal licenses issued.”

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CMS Ends Most Favored Nation Drug Price Model Proposal

According to the Centers for Medicare and Medicaid Services (CMS), the agency has published a final rule in the Federal Register on December 27, 2021, that rescinds the November 27, 2020, MFN Model interim final rule with comment period.​​ The final rule rescinding the Most Favored Nation Model interim final rule with comment period can be found here.

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Senator Wyden Requests FTC To Investigate Retail Pharmacy Market Consolidation

In a recent press release Senator Wyden (D-OR) has sent a letter to the Federal Trade Commission (FTC) to according to “investigate recent consolidations in Oregon’s retail pharmacy market to assess whether large national pharmacy chains and health plans have acted to make this market less competitive.”

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House Committee on Oversight and and Reform Releases Report on Drug Pricing

Last week Representative Maloney (D-NY) who is the Chairwoman of the Committee on Oversight and Reform released the final staff report, resulting from a multi-year investigation into drug pricing. The Committee investigation was originally started by the late Representative Cummings.

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CURES 2.0 Biomedical Legislation Introduced Into Congress

U.S. Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) are back as they recently introduced their long anticipated and bipartisan Cures 2.0 legislation. The bill is discussed via Congresswoman DeGette’s press release.

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Pharmacy Celebrates Another Win Over PBMs in the 8th Circuit

This week the 8th Circuit issued a decision in the case of Pharmaceutical Care Management Association v. Wehbi, which supported North Dakota’s legislative actions to regulate pharmacy benefit managers (PBMs). PCMA v. Wehbi is the first case at the federal appellate level since the landmark Rutledge v. PCMA decision last year that upheld Arkansas law also regulating PBMs.

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FDA Approves First Interchangeable Biosimilar for Humira

According to the FDA’s press release, “The U.S. Food and Drug Administration approved the first interchangeable biosimilar product to treat certain inflammatory diseases.”

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Biden Administration Issues Interim Final Rule on Surprise Medical Billing

The Centers for Medicare and Medicaid Services (CMS) in conjunction with the Departments of Health and Human Services (HHS), Labor (DOL), Treasury (collectively, the Departments), and the Office of Personnel Management (OPM) has issued an interim final rule with a comment period that seeks to implement the No Surprises Act aimed at surprise medical billing.

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Pharmacy Times Interviews Lanton Law On How COVID-19 May Lead to the Expansion of Practice Laws for Pharmacists Across the Country

Lanton Law PLLC was honored to speak with Medical World News’ Second Opinion on emerging COVID-19 vaccine mandates. It was great sharing this program with Ned Milenkovich of Much Shelist, P.C.

Episode 2 can be viewed here.

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CMS Proposes Rescinding Most Favored Nation Interim Final Rule

The Centers for Medicare and Medicaid Services (CMS) has released a proposed rule that seeks to rescind the Most Favored Nation Model interim final rule with comment period that appeared in the November 27, 2020 Federal Register. CMS is seeking public comment by October 12, 2021.

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Protecting Rural Telehealth Access Act Introduced

Via a recently released a press release describing how a group of bipartisan Senators including Joe Manchin (D-WV), Joni Ernst (R-IA), Jeanne Shaheen (D-NH), and Jerry Moran (R-KS) have introduced the bipartisan Protecting Rural Telehealth Access Act to make current telehealth flexibilities permanent.

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Data Protection Agency (DPA) Legislation Reintroduced

U.S. Senator Gillibrand (D-NY) issued a press release announcing the Data Protection Act of 2021, which would create the DPA, an independent federal agency whose goal is to protect Americans’ data, instill privacy safeguards and work to ensure that there is transparency in data sharing practices.

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House Lawmakers Release Anti-Monopoly Agenda for “A Stronger Online Economy: Opportunity, Innovation, Choice”

According to press release, the House Committee on the Judiciary’s Antitrust Subcommittee Chairman Cicilline (D-RI) and Ranking Member Buck (R-CO) announced their antitrust bi-partisan agenda outlined below:

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New Proposed Congressional DIR Relief Bill

At Lanton Law we are constantly on the watch for issues impacting our specialty, retail and LTC pharmacy clients including the issue of DIR fees. Clients utilize our advocacy and legal tools while discussing business strategy to combat an ever changing reimbursement environment.

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