News & Analysis as of

Physicians Pharmaceutical Industry

New Jersey Bans and Caps Certain Manufacturer Gifts and Payments to Prescribers

by McDermott Will & Emery on

On January 16, 2018, New Jersey’s new regulations limiting gifts and payments from prescription drug and biologics manufacturers to prescribers were issued in the New Jersey Register and became effective. After receiving...more

New Jersey Issues Rules to Chill Drug Manufacturer Payments to Prescribers

by Hogan Lovells on

The New Jersey Attorney General plans to finalize new limits on payments and other benefits that New Jersey licensed prescribers may accept from pharmaceutical manufacturers, although the expected final rule is less...more

“Risk Management Lessons From an Opioid Trial”

The use of opioid medications to treat pain is at a watershed moment in the United States. Over the past three decades, opioids have become a standard and effective component of pain management for many practitioners. They...more

Comment Deadline Approaches for CMS’s Proposed Changes to Medicare Advantage and Part D Programs for CY 2019 – Part 2: Beneficiary...

by Epstein Becker & Green on

On November 28, 2017, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule titled “Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan,...more

Pill Mills, Poppy Flowers, Dead Poets and the Human Resources Department

Having been through a seven-week federal criminal “pill mill” trial, I think a lot about enforcement of the Controlled Substances Act and its effect on physicians. Aggressive enforcement effects others in healthcare as well,...more

Sale of Generic Drug to Physician With “Extensive Information” on the Label May Induce Infringement

In Sanofi v. Watson, No. 2016-2722, the Federal Circuit affirmed the district court’s decision, upholding induced infringement and validity of Sanofi’s patents covering compositions of, uses for, and methods for administering...more

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 5

In this post, I will be focusing on the intersection of off-label communications with government enforcement of health care fraud through the False Claims Act. Over the past eight years, the U.S. Department of Justice (“DOJ”)...more

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

153 Results
|
View per page
Page: of 7
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.