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Physicians Pharmaceutical Industry

Pro Te: Solutio - Vol. 10 No. 3 – Summer 2017

by Butler Snow LLP on

Every summer vacation (or, at least, the ability to take the weekend off!) should include a good read. Whether your preference runs toward a memoir with words of wisdom, a review of new technical advancements, issues of...more

FDA Simplifies and Clarifies Expanded Access Program

by Hogan Lovells on

Last week, FDA announced via a blog post simplifications and clarifications to its expanded access program. Under FDA’s expanded access program, physicians may request that patients with a serious condition receive treatment...more

Proposed New Jersey Regulation Would Restrict Pharma Gifts To Prescribers

by Fox Rothschild LLP on

Gov. Christie’s Administration recently proposed a regulation to curtail the prescription of unnecessary opioid painkillers. Christie, who serves as the Chairman of President Trump’s Commission on Combating Drug Addiction...more

The Growing Number of Civil, Criminal, and Legislative Investigations of Insys Therapeutics, Inc. by Federal, State, and...

by Arnall Golden Gregory LLP on

On September 6, 2017, the U.S. Senate Homeland Security and Government Affairs Committee (HSGAC) released a Minority Staff Report: Fueling An Epidemic: Insys Therapeutics and the Systemic Manipulation of Prior Authorization....more

State Scrutiny of Payments to Providers Growing in Response to Opioid Crisis

by Dorsey & Whitney LLP on

Several states have proposed and enacted new laws to address the opioid crisis, including laws that focus on reducing financial incentives that drug manufacturers can give to providers. Most recently, New Jersey Governor...more

Second Circuit Accepts Appeal of False Claims Act First-To-File Issues

by Farrell Fritz, P.C. on

The Second Circuit recently agreed to accept an interlocutory appeal to decide the question whether a violation of the False Claims Act’s “first-to-file” rule compels dismissal of the complaint or whether it can be cured by...more

Maine Prohibits Certain Gifts from Pharmaceutical Manufacturers and Wholesalers to Practitioners

by King & Spalding on

Last month, the Maine Legislature passed an amendment to the Maine Pharmacy Act to prohibit licensed manufacturers and wholesalers of pharmaceuticals from offering certain gifts to practitioners authorized to prescribe and...more

Nationwide Healthcare Prosecutions Targeting an Array of Practices . . . Is "Just The Beginning"

by Bracewell LLP on

On July 13, 2017, the Department of Justice ("DOJ"), in conjunction with the Department of Health and Human Services ("HHS"), continued its annual tradition of coordinating the filing of charges and sweeping arrests in...more

Giving Telemedicine More Room to Breathe: Recent and Pending State and Federal Actions in the World of Online Prescribing

On October 18, 2008, the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the “Haight Act”) came into law as the federal government’s first attempt to address the public health risks associated with online...more

Opioid Crisis Initiating New State Gift Ban Laws

by Foley & Lardner LLP on

The Maine legislature passed with broad bipartisan approval L.D. 911, An Act to Prohibit Certain Gifts to Health Care Practitioners. The legislation prohibits gifts to practitioners who are licensed to prescribe and...more

Blog: Maine Enacts Gift Ban Law

by Cooley LLP on

Yesterday, An Act To Prohibit Certain Gifts to Health Care Practitioners became law in Maine without the signature of the Governor. 32 MRSA § 13759 prohibits licensed pharmaceutical and medical device manufacturers and...more

Reimbursement Manager Pleads Guilty for Prior Authorization Process Issues

by Bass, Berry & Sims PLC on

On Monday, June 19, 2017, Elizabeth Gurrieri became the second former employee of Insys Therapeutics (Insys) to plead guilty to federal anti-kickback charges related to the drug Subsys, an expensive fentanyl-based painkiller....more

Why do drug prices soar? Blame PBJs, PBMs, weak regulators, and CME

What do PBJs, PBM “black boxes,” industry friendly advisory panels, and CME (aka doctor training programs) all share in common? They’re blamed for contributing to Big Pharma’s skyrocketing prices—and it’s worth diving into...more

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 3

This is Part 3 in my series exploring the history of FDA’s regulation of off-label communications, which has become newly relevant in light of the recent events highlighted in Part 1. In this installment, I continue...more

Value-based health care: fraud & abuse laws

by Ropes & Gray LLP on

Michael Lampert, Ropes & Gray health care partner, discusses fraud and abuse law application to value-based health care arrangements. __ Much has been made about how the fraud and abuse laws, which were designed in order...more

Ninth Circuit En Banc Panel Holds that Central Hudson Survives Sorrell

by Reed Smith on

Last week we bashed a Ninth Circuit Daubert decision. We feel a little bit bad about that, not because the decision wasn’t bashworthy – no, Wendell really is a rotten precedent – but because we hate contributing to the...more

California Bill May Upend Pharma Company Interaction with HCPs

by Morgan Lewis on

The law would prohibit most gifts to healthcare professionals and providers....more

FCA Issues to Watch: Pharmaceutical and Device Developments | INSIDE THE FCA

by Bass, Berry & Sims PLC on

The government’s FCA enforcement efforts have continued to focus on key areas concerning the pharmaceutical and medical device industries. In fact, drug and device manufacturers accounted for nearly half of the enforcement...more

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 2

In my last post, I introduced a series of posts that will explore FDA’s historical approach to off-label drug and device communications, how that position has evolved (or not) to the modern day, and predict where that policy...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

JAMA Article: Obstacles to the Adoption of Biosimilars for Chronic Diseases

by Goodwin on

Generic drugs currently account for 88% of all U.S. prescriptions, yielding 10-year cost savings in excess of $1.5 trillion. There is some optimism that biosimilars will offer a similar low-cost therapeutic alternative to...more

Product Liability Update: April 2017

by Foley Hoag LLP on

Massachusetts Federal Court In Prescription Drug Case Holds “Learned Intermediary” Rule Requiring Warnings Only To Prescribing Physician Applied Even Though Patient and Caregiver Were Physicians, But Experts’ Affidavits of...more

The Continuing Story of Manufacturers' Off-Label Promotion of Approved or Cleared Medical Products

by Jones Day on

Prior to the end of the previous Administration, FDA released several draft guidance documents and a white paper addressing different types of communications about medical products. On January 18, 2017, FDA published two...more

Healthcare Fraud and Abuse Review 2016

by Bass, Berry & Sims PLC on

Bass, Berry & Sims is pleased to announce the release of its fifth annual Healthcare Fraud and Abuse Review 2016. The Review, compiled by the firm’s Healthcare Fraud Task Force, is an industry-leading guide to healthcare...more

Disputing Inaccurate Reports Under the Physician Payment Sunshine Act

by Ruder Ware on

The Affordable Care Act added the Physician Payment Sunshine Act (Sunshine Act) as section 1128G to the Social Security Act. The Sunshine Act requires applicable manufacturers of drugs, devices, biologicals, or medical...more

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