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Manufacturers Pharmaceutical Industry Health Care Providers

Preparing for the Opioid Litigation Epidemic

by Kelley Drye & Warren LLP on

One of the newer symptoms of this so-called “Opioid Epidemic,” is a rash of litigation targeting pharmaceutical manufacturers and distributors. Currently, there are actions underway in Texas, West Virginia, Alabama, Ohio,...more

A Path Forward: Corporate Integrity Agreement Sheds Light on Manufacturer Interactions With Independent Charitable Foundations

by Hogan Lovells on

Manufacturers of pharmaceuticals and biologics have been closely watching the industry-wide investigation by the Boston U.S. Attorney's Office into manufacturer support of independent charitable foundations that assist...more

Citing the Opioid Abuse Epidemic, New Jersey Proposes Far-Reaching Restrictions on Pharma-Prescriber Interactions

by Stinson Leonard Street on

In an effort to curtail the opioid abuse epidemic, New Jersey Governor Chris Christie proposed a new rule on August 31, 2017 that would make New Jersey the latest state to adopt "gift ban" type restrictions on interactions...more

New Jersey Joins Wave of States Proposing New Rules for Drug Marketing and HCP Interactions

by Hogan Lovells on

Drug manufacturers are once again facing new state limits on marketing and interactions with healthcare providers. Manufacturers should review the new laws and regulations carefully, consider how they might engage with the...more

Healthcare Law Update: September 2017

by Holland & Knight LLP on

OIG Advisory Opinions - Manufacturer's Free Replacement of Spoiled Pharmaceutical Products Authorized - On Aug. 25, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG)...more

OIG’s Expanded Interpretation of Warranty Safe Harbor Portends Well for Value-Based Health Care

by Ropes & Gray LLP on

In a new advisory opinion, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) clarified the scope of the Anti-Kickback Statute (“AKS”) warranty safe harbor (the “Warranty Safe Harbor”). In...more

New Maine Law Limits Manufacturer and Wholesaler Interactions with Health Care Professionals

by McDermott Will & Emery on

Maine recently amended its Pharmacy Practice Act to prevent licensed manufacturers or wholesalers and their agents from offering or giving certain gifts to practitioners. The bill’s sponsor tied the issue of gifts from...more

Health Care Provider Insights - Introductory Edition

by Wilson Elser on

Welcome to the introductory edition of Health Care Provider Insights. We are practice management consultants, providing legal and business management advice and assistance to physicians and dentists (health care...more

Beyond the Label: FDA Addresses Permissible Scope of Communications With Payors and Physicians

by Pepper Hamilton LLP on

The draft guidances create a grey area between “on-label” and “off-label” communications that will require careful navigation as manufacturers develop HCEI analyses and promotional communications....more

Drug Manufacturer Pricing Under the Microscope: HRSA’s 340B Civil Monetary Penalty and Drug Pricing Final Rule

by Polsinelli on

The Health Resources and Services Administration recently surprised the 340B Drug Pricing Program community with the release of its regulations pertaining to drug manufacturer ceiling price calculations and civil monetary...more

21st Century Cures: A Closer Look

by McDermott Will & Emery on

On December 7, 2016, the US Congress enacted the 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by encouraging biomedical research investment,...more

Medicinal Product Regulation and Product Liability in Australia: Overview

by DLA Piper on

The Therapeutic Goods Act 1989 (Cth)(TG Act): - Provides a national framework for the regulation of medicinal products. - Provides a national system to control the quality, safety, efficacy and timely availability...more

The Continuing Evolution of the French Sunshine Act

by Reed Smith on

Since the general disclosure rule for provider-manufacturer relationships in France was enacted into law on January 1, 2012, its compliance and enforcement have been a common point of discussion for health care professionals,...more

It Is Finally Here-the Sun Shines on a New Era

by BakerHostetler on

The Centers for Medicare and Medicaid Services (CMS) publicly launched a database this week detailing the payments doctors and teaching hospitals have received from drug and medical device manufacturers. Under the Physician...more

FDA Draft Guidance Aims to Clarify Appropriate Character-Space-Limited Social Media Use by Drug and Device Firms: Part One of Two

by Snell & Wilmer on

As technology continues to evolve, so do the ways in which patients and healthcare providers obtain information pertaining to medical products regulated by the Food and Drug Administration (FDA). Thomas Abrams, Director of...more

Strict Products Liability Claims Based On Design Defect Are Inapplicable To Implanted Medical Devices That Are Available Only...

A recent California Court of Appeal decision out of the Second District has provided further clarity to the scope of California products liability law by reasserting the general rule that precludes strict liability for design...more

Massachusetts Pharmaceutical and Medical Device Manufacturer Conduct: Final Amendments to Be Issued

by Epstein Becker & Green on

On November 21, 2012, the Massachusetts Public Health Council approved final amendments to 105 Mass. Code Regs. 970.000, the Massachusetts Pharmaceutical and Medical Device Manufacturer Conduct Law ("Massachusetts Marketing...more

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