Prescription Drugs

News & Analysis as of

340B Program Ceiling Price and CMP Final Rule Delayed Until May 22

On 20 March 2017, the Health Resources and Services Administration (HRSA) published an Interim Final Rule (IFR) delaying the effective date of the 340B Ceiling Price and Civil Monetary Penalties (CMP) Rule (the Final Rule)...more

Medicinal Products: the EU and the US Mutually Recognize Manufacturing Standards

The European Union (“EU”) and the United States (“US”) have reached a sectoral agreement (the “Agreement”) that will greatly ease the administrative burden when proving compliance with Pharmaceutical Good Manufacturing...more

Novartis Secures FDA Approval for Breast Cancer Drug Kisqali

On March 13, 2017, the use of Novartis cell cycle inhibitor Kisqali® (ribociclib, LEE011) in combination with an aromatase inhibitor was approved by the U.S. Food and Drug Administration as a first-line treatment for...more

Wyden’s C-THRU Act – Publicizing PBM Rebate Data

Last week, Senate Finance Committee Ranking Member Ron Wyden (D- Ore.) introduced the “Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017.” As its name suggests, it seeks to require parties (e.g., PBMs)...more

The Future of the Affordable Care Act Week 7: The American Health Care Act

On March 6, 2017, after years of promising, GOP lawmakers in the House of Representatives introduced the “American Health Care Act” (AHCA), the first concrete legislative proposal detailing the initial provisions designed to...more

Health Care E-Note - March 2017

Like pain clinics and pharmacies, practitioners treating substance use disorder appear to be a target for federal enforcers. Under President Trump's administration and Alabama Attorney General Steve Marshall, law enforcement...more

Manatt on Health Reform: Weekly Highlights - March 2017 #3

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

340B Ceiling Price/CMP Rule Effective Date Pushed Back to May 22, 2017 — “At the Earliest”

The Health Resources and Services Administration (HRSA) is delaying the effective date of its January 5, 2017 final rule on the calculation of the ceiling price and application of civil monetary penalties (CMPs) under the...more

Federal Enforcement Focuses on Drug Treatment Clinics

Like pain clinics and pharmacies, practitioners treating substance use disorder appear to be a target for federal enforcers. Under President Trump’s administration and Alabama Attorney General Steve Marshall, law enforcement...more

Another Court Tackles Prescription Drug Design Defect

If you have been following along for a while, then you have surely run across our posts making some combination of the following points: 1) design defect claims rarely make sense for a drug because changing the design in...more

The Uncertain Future of the 340B Drug Discount Program

Here we are in March 2017 and no one is sure where things stand with the 340B Drug Discount Program. HRSA and its oversight of the 340B program are subject to the recent Executive Orders restricting issuance of federal...more

Congress is About to Take Away Your Rights

The U.S. Congress is fighting hard to take away your rights and the power of individual states to protect those rights. The influence of BIG BUSINESS over your elected representatives is being used protect careless and...more

Health Alert (Australia) March 13, 2017

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: Commonwealth. Fair Work Commission 7 March 2017 - Mrs Glenyce Ham v Dr Allan Clarke T/A CJ Orthopaedics Pty Ltd [2017]...more

What Can Friend Expect after Arrest over Medicine at Airport?

Question: A friend of mine called me recently to say that he had been arrested at Dubai airport for carrying prescription medicine without the prescription. I am a European who lives outside the UAE so I don’t have much...more

Combatting illegal pharma trade: Combatting black and grey markets for the pharmaceutical industry

Focus I: International black market trade - Among the industries that suffer most from black and grey market activities, the pharmaceutical sector sadly holds one of the top positions. The World Health Organization (WHO)...more

Better Healthcare Newsletter from Patrick Malone - March 2017

Avoid diabetes' dire harms - You’ve heard an earful about the dangers of diabetes since you were a kid. Your parents may have tried to grab back that big bag of Halloween candy by telling you that too much sugar causes...more

Florida Private Sector Whistleblower Must Show Actual Violation of Law

The Southern District of Florida recently held that to establish a prima facie case under the Florida Private Whistleblower Act (FWA), § 448.102(3), Fla. Stat., a plaintiff must show an actual violation of a law, rule or...more

U.S. FDA and EU Regulators Announce Enhanced Mutual Recognition for Pharmaceutical Manufacturing Inspections; Allows FDA to...

In an effort to avoid the duplication of drug inspections, lower inspection costs, and enable regulators to devote more resources to other parts of the world where there may be greater risk, the U.S. Food and Drug...more

New Mexico Senate Passes Bill Allowing Automatic Substitution of Interchangeable Biologics

Last week, the New Mexico Senate passed a bill that would amend New Mexico’s existing automatic substitution law for small molecule drugs to allow “a pharmacist to dispense any one of the … interchangeable biological products...more

First Biosimilar in Oncology, TRUXIMA, Granted Marketing Approval in European Union

We previously reported that the Committee for Medicinal Products for Human Use (CHMP) had recommended that the European Medicine Agency (EMA) grant marketing approval for Truxima (CT-P10), Celltrion Healthcare’s biosimilar of...more

What’s in store for the Affordable Care Act and drug pricing policy under the Trump administration?

The Trump administration has been vocal in its criticism of the Affordable Care Act (ACA), and already has worked with the Republican-controlled Congress to begin rolling back key provisions of the legislation. The promised...more

FDA Publishes Guidance on Off-Label Use Communications

The U.S. Food and Drug Administration (FDA) recently released two draft guidance documents and a memorandum related to off-label communications and the FDA’s power to regulate such communications. The publications are the...more

Pending Alabama Tax Legislation (2017 Regular Session) State and Local Tax Alert: Alabama Edition

The House and Senate have each met a total of six legislative days thus far. There are therefore 24 legislative days remaining in the 2017 Regular Session. The House will reconvene on Tuesday, February 28 at 1:00 p.m. The...more

The Federal Circuit Found Direct Infringement Attributable to Physicians Where “No Single Actor Performs All Steps of a Claim"

Can a patient’s action in taking a generic drug be attributable to a physician such that it can support a finding of the physician’s direct patent infringement? According to a recent precedential opinion of the Court of...more

Sixth Circuit Affirms Branded Drug Preemption and Trial Win

In the aftermath of Levine, with its generous interpretation of the CBE regulation and its novel “clear evidence” standard, we wondered how long it would be until we saw a court holding that a failure to warn claim with a...more

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