Pharmaceutical Industry Healthcare

News & Analysis as of

Bipartisan Energy & Commerce Committee Leaders Release Updated 21st Century Cures Draft

Today the bipartisan leadership of the House Energy and Commerce Committee released their 2015 version of the 21st Century Cures Act, which is intended to bolster medical discovery, treatment development, and delivery of...more

Massachusetts Legislation Proposes Cost Disclosures and Price Caps for Prescription Drugs

The Massachusetts Legislature is currently considering Senate Bill 1048, “An Act to Promote Transparency and Cost Control of Pharmaceutical Drug Prices.” The bill, sponsored by State Senator Mark Montigny, Vice Chair of the...more

FTC Settles Radioactive Allegations Against Cardinal Health with a Near Record-Breaking Disgorgement Agreement

In a 3-2 decision, as part of its aggressive antitrust enforcement in health care industries, the Federal Trade Commission (FTC or the Commission) announced that Cardinal Health, Inc. (Cardinal) agreed to pay $26.8 million to...more

OMB Reviewing HRSA Proposed Rule For Civil Monetary Penalties And Ceiling Price Regulations For 340B Drug Discount Program

The agency that oversees the 340B Drug Discount Program (340B program) is seeking review by the White House Office of Management and Budget (OMB) of a proposed rule that would use civil monetary penalties to enforce ceiling...more

CMS Issues Guidance on Reimbursement for Biosimilars under Medicare and Medicaid

Biosimilars Are Generally Treated as Single Source Drugs - On March 30, 2015, in the wake of the first biosimilar product licensed by the Food and Drug Administration (FDA), the Centers for Medicare & Medicaid Services...more

CMS Takes Initial Steps to Address Medicare & Medicaid Coverage for Biosimilars

On March 30, 2015, CMS released guidance addressing Medicare and Medicaid coverage for biosimilar drug products. The Medicare/Medicaid coverage guidance comes on the heels of the FDA’s landmark approval of a biosimilar...more

Washington Healthcare Update

This Week: CMS Releases Three Documents on Biosimilar Reimbursement... SCOTUS: Agencies, Not State Courts, in Charge of Medicaid Rate Setting... HHS OIG and Treasury IG Release Report on ACA’s Advanced Premium Tax Credits....more

Open Payments/Sunshine Act Year Two: Guidance for Physicians

On June 30, 2015, the Centers for Medicare and Medicaid Services (CMS) will publish the first full-year report of payments to physicians from pharmaceutical and medical device manufacturers. Physicians who want to review...more

Biosimilars Await Naming Guidance From FDA

Earlier this month, the FDA announced the first approval of a biosimilar product under the Biologics Price Competition and Innovation Act (BPCIA). The new Sandoz product, which will be sold under the trade name Zarxio, is a...more

Health Alert (Australia) - March 23, 2015

In This Issue: Judgments; Legislation; and Reports. Excerpt from Reports: New South Wales (NSW). Ministry of Health - Media Releases - 18 March 2015 - NSW says protect against mosquitoes after huge...more

Notes From The Off-Label Underground

Keeping track of litigation over off-label use/promotion frequently sends us off on tangents. We’ve wandered into abortion cases, securities law cases, criminal cases – even cases brought by criminals....more

FDA Issues Draft Memorandum of Understanding for 503A Drug Compounding

Included in the flurry of guidance documents recently issued by the FDA concerning human drug compounding is a long-awaited document of great importance to mail-order pharmacy compounders and entities that rely on interstate...more

FDA Guidance Documents Change Compounding Landscape

Almost a year and a half after adoption of the Drug Quality and Security Act (DQSA) in November 2013, which revised federal oversight of drug compounding, the Food and Drug Administration (FDA) continues to roll out guidance...more

State Medicaid Programs May Be Leaving Revenue From Drug Rebates on the Table

The recent release of a New York State Office of the State Comptroller audit report serves as an example of state Medicaid programs that may not be maximizing their collection of revenue from drug rebates for Medicaid managed...more

340B in the Spotlight This Thursday: Congress Offers Webcast of Upcoming Hearing Regarding the 340B Drug Pricing Program

Thursday, March 5th at 10:00 a.m. EST, the House Energy & Commerce Health Subcommittee on Health will hold a hearing entitled, “Examining the 340B Drug Pricing Program.” The purpose of the hearing is to review the...more

Cardinal Health to Acquire Cordis for $2 Billion

(March 2, 2015) Johnson & Johnson announced that Cardinal Health has made a binding offer to acquire Cordis, a Johnson & Johnson company, for $1.99 billion. The press release indicates that the sale price includes $1.944...more

Generic Drug Price Hike Investigations Target Lannett

Since we last reported on state and federal investigations into recent generic drug price increases, the investigations have moved forward against Philadelphia-based Lannett Co. On November 20, a Senate healthcare...more

Blog: Vermont AG Announces Another Disclosure Law Enforcement Action

the Vermont Office of the Attorney General (“VT AG”) previously published several enforcement actions taken against manufacturers of pharmaceutical, biological and medical devices for failing to comply with the state’s...more

Proposed FDA Overhaul to Improve Biomedical Discovery and Development

The House of Representatives and the Senate are assessing significant reforms to the Food, Drug and Cosmetic Act. The reforms are aimed at accelerating the approval of new drugs, medical devices and other products regulated...more

21st Century Cures Congressional Panel Unveils Medical Technology Proposals

On January 27, 2015, members of the House Commerce and Energy Committee unveiled a set of legislative proposals aimed at speeding up the development of new medical technology. The 21st Century Cures panel, a bipartisan...more

The Cure for the Common FDA Reform Legislation? House Committee Releases 21st Century Cures Discussion Draft

On January 27, 2015, the House Energy & Commerce Committee (“E&C Committee”) released a long-awaited discussion draft of comprehensive medical innovation reform legislation as part of its 21st Century Cures Initiative....more

Ensuring Data Protection In The Implementation Of The EFPIA Disclosure Code: Key Challenges And How Pharmaceutical Companies Are...

The EFPIA Disclosure Code will, from 2016, require pharmaceutical companies to disclose details of payments and transfers of value made to healthcare professionals and healthcare organisations. The Code aims to promote,...more

A Quick Look at Healthcare Issues Expected to Make News in 2015

As we look into our crystal balls, we do not expect a lot of new issues in 2015. Rather, we believe that most of the significant issues will be a continuation of issues that arose in 2014 or earlier. ...more

FDA Regulatory and Compliance Monthly Recap - December 2014

FDA replaces pregnancy labeling system with a new standard in a bid to provide more clarity - The regulator is discarding its decades-old system to explain the risks of prescription drugs to women who are pregnant or...more

The M&A Outlook in the Middle East: A Look Back at 2014 and Beyond

The Megatrends in Mergers & Acquisitions conference held in October 2014 focused on the evolving M&A landscape, promoting inbound and outbound M&A in the Middle East, and general industry trends. Among the speakers at the...more

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