Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 203: Manufacturing Specialty Drugs for Rare Diseases in North Carolina with Paul Testa of Kyowa Kirin
The DEA Is Knocking at Your Door . . . Are You Prepared? – Diagnosing Health Care
The Latest on Healthcare Enforcement
340B Drug Pricing Program Compliance
Podcast: The Legal Battle Over Mifepristone - Diagnosing Health Care
[Podcast] Food for Thought and Thoughts on Food: What to Expect in 2023
Podcast: Post-Dobbs Access to Reproductive Health Care and Abortion-Inducing Drugs - Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 116: Michael Carlin, Manager, Engage HCP by TrialCard
Hospice Audit Series: Beyond Part D, OIG Scrutinizes the Hospice Industry to the Tune of $6.6 Billion
PODCAST: Williams Mullen's Benefits Companion - New Prescription Drug and Health Coverage Reporting Requirements
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Fee Waivers for Small Businesses: Who Qualifies for the Small Business User Fee Waiver for Drugs and Biologics and How to Apply
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - 2020 Year in Review on FDA’s Enforcement of Rx Drug Promotions & Trends
Part Two: The MFN Drug Pricing Rule and the Rebate Rule: Where Do We Go From Here?
Part One: Two new Medicare Drug Pricing Rules in One Day: What are the MFN and the Rebate Drug Pricing Rules?
On the Ballot 2020: Health Care Policy Outlook - Diagnosing Health Care Podcast
Key Considerations for Reshoring U.S. Drug Manufacturing
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Quality Agreements for FDA-Regulated Products: Looking Under the Hood
Product Launching in the Era of COVID-19 - Diagnosing Health Care Podcast
Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
On August 29, 2024, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued an untitled letter to AbbVie, Inc. (AbbVie) regarding a promotional, direct-to-consumer (DTC) television...more
As prescription drug costs remains a significant, and largely bipartisan, issue for state and federal legislators, we continue to see activity focused on pharmacy benefit managers (PBMs) as we approach the last quarter of...more
On September 13, 2024, Alteogen announced that it has applied for marketing authorization in Korea for ALT-L9, an aflibercept biosimilar of EYLEA®. According to Alteogen, a 12-country Phase 3 study showed that ALT-L9...more
The 340B Drug Pricing Program continues to provide critical support for covered entities, although the program is subject to ongoing scrutiny and congressional, judicial, and industry pressures. Certain key guidance documents...more
As we enter into the final months of 2024, new developments in the administration of the 340B Drug Pricing Program signal that additional reform may be on the way. Although recent revisions to the 340B program’s...more
More plaintiffs are continuing to join the diabetes drug Ozempic lawsuits against Novo Nordisk; and, until a couple of weeks ago, some court watchers were estimating that the total number of federal lawsuits involving Ozempic...more
On August 23, Johnson & Johnson (J&J) issued a written notice to disproportionate share hospitals that participate in the prescription drug discount program established under section 340B of the federal Public Health Service...more
In recent years, China has introduced significant changes to its Drug Administration Law and corresponding legislation, including the nationwide Market Authorization Holder (MAH) system. These reforms aim to boost foreign...more
This chart summarizes the case name, presiding judge, drug, and patents-at-issue in all federal district court cases that are filed pursuant to the Hatch-Waxman Act. It also includes the same information for proceedings...more
This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications....more
While audits are part of doing business in the ordinary course, businesses are generally less than eager to open the books. And the same is true when it comes to the 340B Drug Pricing Program. Audits are now making the list...more
As we have previously reported, the Inflation Reduction Act (IRA) changed the government’s treatment of certain prescription drugs under the Medicare program by directing the Secretary of Health and Human Services (HHS) to...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
On August 8, 2024, the US Food and Drug Administration (FDA) partially revised the availability of certain glucagon-like peptide 1 (GLP-1) medications on the FDA’s shortage list. In particular, FDA updated the availability of...more
On July 8, 2024, the Food and Drug Administration (FDA) released updated draft guidance, “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers,” that replaces similar guidance from...more
The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-07 (the “Opinion”), to a nonprofit tax-exempt grant-making...more
Congress Returns. The House and Senate will be back in session on September 9, 2024, with a joint focus on completing consideration of a continuing resolution (CR) to maintain government funding beyond the end of fiscal year...more
On August 15, 2024, the Centers for Medicare & Medicaid Services (CMS) released the first set of negotiated prices for the Medicare Drug Price Negotiation Program for 2026. Authorized under the Inflation Reduction Act of...more
Pharmacies, wholesalers, third-party logistics providers, outsourcing facilities, clinics, and pharmacists must obtain the California State Board of Pharmacy’s (the “Board”) approval or otherwise notify the Board about...more
The Hatch-Waxman Act regulates the relationship between branded and generic drugmakers and attempts to strike a balance between two competing policy interests — encouraging pioneering drug development and facilitating market...more
On August 20, 2024, OIG issued Advisory Opinion No. 24-07 in which it responded to a request for an advisory opinion regarding a nonprofit grant-making organization’s (Requestor) proposal to fund a patient assistance program...more
Approval of Celltrion’s Ustekinumab Biosimilar in the EU: On August 26, 2024, Celltrion announced that the European Commission (EC) granted approval for STEQEYMA, formerly known as CT-P43, a biosimilar of STELARA...more
This chart summarizes the case name, drug, patents-in-suit, and publicly available terms for reported settlements in federal district court cases that are filed pursuant to the Hatch-Waxman Act....more
On August 22, Moderna announced that FDA approved its supplemental Biologics License Application (“sBLA”) for a new formula of their COVID-19 vaccine, SPIKEVAX®, for individuals 12 years old and above. Emergency Use...more
On August 21, Oregon’s Prescription Drug Affordability Board (PDAB) reviewed a draft upper payment limit (UPL) constituent engagement report, which captured feedback from patients, providers, health plans, manufacturers, and...more