News & Analysis as of

Drug Pricing

Pfizer and Flynn Pharma fined €101 million for charging the UK health service excessive prices for Phenytoin sodium capsules, an...

by Dechert LLP on

The UK Competition and Markets Authority (“CMA”) recently published its infringement decision of 7 December 2016 that imposed a fine on Pfizer and Flynn Pharma (“Flynn”) for abusing their respective dominant positions by...more

Blog: California Governor Considers Drug Price Reporting Bill and Ban on Discounts and Rebates for Branded Pharmaceutical Products

by Cooley LLP on

The California State Legislature sent two new pharmaceutical pricing measures, S.B. 17 and A.B. 265, to Governor Jerry Brown on September 13th. S.B. 17 would impose new reporting requirements on pharmaceutical manufacturers...more

Capitol Hill Healthcare Update

by BakerHostetler on

The chairman of a Senate healthcare committee outlined a key test for stabilizing the Affordable Care Act’s (ACA) shaky individual marketplace: Both Republicans and Democrats will have to give a little. That formula has...more

HRSA Proposes Delaying 340B Drug Pricing Program Reforms until July 1, 2018

by Reed Smith on

The Trump Administration is proposing to once again push back the effective date of a January 2017 final rule making changes to the calculation of the 340B “ceiling price” that may be charged to covered entities and related...more

CMS Outpatient Advisory Panel Speaks Out Against Planned 340B Cuts

by King & Spalding on

On August 21, 2017, a CMS advisory panel consisting of provider representatives recommended that CMS not finalize its proposed rule to reduce payments for outpatient drugs to hospitals under the 340B Drug Pricing Program....more

Excessive Pricing in Generic Drug Markets

by Ropes & Gray LLP on

EU and UK antitrust laws make it illegal for dominant firms to charge unfair or excessive prices. These laws have most often been applied in markets that feature high barriers to entry or expansion, which enable a dominant...more

340B Update: HRSA Delays Final Rule on 340B Pricing and Manufacturer CMPs Yet Again

by K&L Gates LLP on

On August 21, 2017, the Health Resources and Services Administration (“HRSA”) published a Notice of Proposed Rulemaking to further delay the effective date of final rules on drug pricing calculations and civil monetary...more

K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program

by K&L Gates LLP on

cmsThis episode outlines the basics of the 340B Drug Pricing Program and discusses potential changes affecting the program, including CMS’s recent proposal to cut reimbursement for Part B drugs purchased under the 340B...more

K&L Gates Triage: 340B Eligibility - Hospital Covered Entities

by K&L Gates LLP on

This podcast focuses on the eligibility requirements for hospitals participating in the 340B Drug Pricing Program. Factors affecting eligibility include a hospital’s licensure status, patient population, and Medicare...more

There'll Be Some Changes Made: President Signs Prescription Drug and Biologic User Fee Reauthorization Act

by Hogan Lovells on

On August 18, 2017, President Trump signed into law the FDA Reauthorization Act (FDARA). FDARA reauthorizes user fees paid to FDA to support regulatory review of innovator drugs and biologics, medical devices, generic drugs,...more

China proposes new rules to address perceived anti-competitive practices in the pharmaceutical industry

by Hogan Lovells on

On 14 August 2017, the National Development and Reform Commission ("NDRC") released a draft of the Guidelines on Pricing Conduct by Business Operators for Drugs in Shortage and Active Pharmaceutical Ingredients ("Draft...more

340B Covered Entities Beware: CMS Proposes Drastic Drug Reimbursement Rate Cuts

by Polsinelli on

In its Outpatient Prospective Payment System proposed rule ("Proposed Rule"), CMS outlined a significant Medicare Part B payment reduction for separately payable, nonpassthrough drugs provided in the hospital outpatient...more

Senate Passes Long-Awaited FDA User Fee Package

Following nearly two years of negotiations and hearings examining the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA), the Prescription Drug User Fee Act (PDUFA) and the Medical Device User...more

The “Pharma Bro” Trial—Who Really Won?

After a five-week trial, a jury of five men and seven women convicted notorious pharmaceutical executive Martin Shkreli of securities fraud on August 4, 2017. Shkreli had been charged with two counts of securities fraud,...more

Martin Shkreli Convicted on Three of Eight Counts of Securities Fraud

On Friday, August 4, 2017, a federal court jury in Brooklyn, New York, found Martin Shkreli, former CEO of biopharmaceutical company Retrophin, guilty on three of eight counts of securities fraud. The verdict followed five...more

Investigations in the Healthcare Sector by the French Competition Authority: Drugmakers’ Potential “Excessive Pricing” At Stake

by Reed Smith on

French competition authority to start investigations into potentially “excessive prices” in the healthcare market in the next weeks, following increasing scrutiny across Europe. On 3 July 2017, the president of the French...more

CMS’s 340B Proposal Is Likely Unlawful—Here’s Why

by Morgan Lewis on

The agency’s recent proposal to reduce certain drug reimbursement is unprecedented and not based on a reasonable interpretation of its statutory authority....more

Money’s big for Big Pharma — in settlements, lobbying, and product prices

Even as drug makers are settling or scrambling to resolve disputes with regulators over dubious ways they peddle products, Big Pharma is busting records for its spending to lobby lawmakers on skyrocketing prices, easing...more

Update on Successes and Hurdles in Improving 340B Program Oversight

On July 18, 2017, the Government Accountability Office (GAO) issued a follow-up report entitled “Update on Agency Efforts to Improve 340B Program Oversight.” In its initial report in 2011, the GAO highlighted the inherent...more

Baker Administration and Legislature Debate Range of Health Care Proposals

Massachusetts policymakers are currently engaged in a robust debate over several proposals aimed at lowering health care costs in the Commonwealth. The House of Representatives rejected a set of MassHealth reforms that the...more

House Energy And Commerce Committee Hearing Holds Oversight Hearing on the 340B Drug Price Program

by King & Spalding on

On July 18, 2017, the House Energy & Commerce’s Oversight and Investigations Subcommittee held a hearing on “Examining HRSA’s Oversight of the 340B Drug Pricing Program.” The hearing featured a single panel of three federal...more

CMS Proposes Medicare OPPS, ASC Update for CY 2018

by Reed Smith on

CMS has published its proposed rule to update Medicare Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) payment system rates and policies for calendar year (CY) 2018. In addition to...more

Witnesses at Congressional Hearing on 340B Urge Congress To Give HRSA Broader Regulatory Authority

On July 18, 2017, just days after CMS went public with its proposal to reduce Medicare Part B reimbursement to certain 340B covered entities, Congress held its first hearing on 340B Program Oversight since March 2015. A...more

Capitol Hill Healthcare Update

by BakerHostetler on

Senate Republicans face a key procedural vote this week that would allow for debate of their healthcare legislation, but significant uncertainty remains about whether GOP senators can meet that procedural hurdle, what the...more

House Committees Examine Health Care Policy Issues

by Reed Smith on

Recent House of Representatives committee hearings have focused on a variety of health care policy issues, including the following: Energy and Commerce Committee hearings on: the growth and oversight of the 340B drug...more

323 Results
|
View per page
Page: of 13
Cybersecurity

"My best business intelligence,
in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.