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
In 1984, the international rock band, The Scorpions, released the song, “Rock You Like a Hurricane.” Forty years later, the Food and Drug Administration’s Office of Prescription Drug Promotion rocked a pharmaceutical company...more
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
In a stride toward transparency and heightened consumer awareness, the Food and Drug Administration (FDA) has issued a final rule, dated November 21, 2023, to amend its regulations regarding direct-to-consumer (DTC)...more
On November 21, 2023, the FDA published its final rule changing how prescriptions medicines are advertised to consumers. The FDA first issued its proposed rule in 2010, which subsequently went through three public comment...more
Who doesn’t remember Hall and Oates’ 1984 hit, “Out of Touch?” Perhaps, reviewers in the Food and Drug Administration’s Office of Prescription Drug Promotion were humming this song when it recently issued an Untitled Letter...more
Late last year, the Food and Drug Administration’s Office of Prescription Drug Promotion issued an Untitled Letter to a drug company for unlawful promotion of its biologic product....more
The Food and Drug Administration’s Office of Prescription Drug Promotion isn’t letting the Dog Days of Summer stop it from taking action against what it perceives as unlawful marketing. In its first Untitled Letter of 2020...more
U.S. health officials have taken the first concrete step toward implementing the vision set out in the “American Patients First” blueprint published by President Trump and Health and Human Services (HHS) Secretary Alex Azar...more
Yesterday, May 8, 2019, the Centers for Medicaid & Medicaid Services (“CMS”) released its final rule requiring drug manufacturers to disclose a drug’s wholesale acquisition cost (“WAC”) in direct-to-consumer television...more
Ever since the FDA approved advertisements for prescription drugs on television, pharmaceutical companies have been heavily relying on them and collectively represent the third highest spender of any industry in national TV...more
On October 17, 2018, the Food and Drug Administration published a draft guidance for industry on “Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements.” ...more
On October 18, 2018, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule that would require direct-to-consumer (DTC) television advertisements for prescription drugs and biological products for which...more
On October 15, CMS released a proposed rule titled “Medicare and Medicaid Programs: Drug Pricing Transparency,” which would require direct-to-consumer (DTC) advertisements for prescription drugs covered by Medicare or...more
The Administration has continued its push to address the issue of high drug prices through the regulatory process. On October 15, 2018, the Department of Health and Human Services (HHS) issued a proposed rule to require drug...more
Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health...more
The Trump Administration released a draft regulation published in the Federal Register on October 18, 2018, which proposes to require drug manufacturers to include a drug’s list price in its direct-to-consumer (DTC)...more
In the first new guidance document from FDA in several years specific to the subject of direct-to-consumer (DTC) promotion of prescription drugs and biological products, the Agency is recommending that companies take...more
The Trump Administration is moving full speed ahead with its proposals under the Blueprint to Lower Drug Prices (the “Blueprint”). Earlier this week, the Centers for Medicare & Medicaid Services (“CMS”) released a proposed...more
The Pharmaceutical Research and Manufacturers of America (PhRMA) released today updated Guiding Principles: Direct to Consumer Advertisements About Prescription Medicines (Guiding Principles), which will be effective April...more
House Republicans append a Manager's Amendment to the AHCA; HHS tells states they will have increased flexibility on Medicaid; and Florida previews its 1115 waiver amendment requests....more