Tag: pharmaceutical

Q4 Government Settlements Round-Up: Life Sciences

The U.S. Department of Justice (DOJ) and other government enforcers announced a number of key settlements in the life sciences industry in October – December 2019. These settlements include: LIFE SCIENCES INDIVIDUALS/ ENTITIES SETTLEMENT DATE RESOLUTION KEY AREAS OF ENFORCEMENT Pharmaceutical company Dec. 3, 2019 $3 million Deferred prosecution agreement […]

Q3 GOVERNMENT SETTLEMENTS ROUND-UP: LIFE SCIENCES

The U.S. Department of Justice (DOJ) and other government enforcers announced a number of key settlements in the life sciences industry in July – September 2019. These settlements include: LIFE SCIENCES INDIVIDUALS/ ENTITIES SETTLEMENT DATE RESOLUTION KEY AREAS OF ENFORCEMENT Pharmaceutical company Sept. 26, 2019 $108M Deferred prosecution agreement Forfeiture […]

Maine Enacts Gift Ban Law

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 wholesalers from providing a gift to a practitioner. Exceptions include: noncash items of minimal value that directly benefit the practitioner’s patients, […]

Trend watch: First Amendment challenges to FDA promotional requirements continue

In the wake of Amarin Pharma’s victory in securing a preliminary injunction against the Food and Drug Administration’s (FDA) prohibition of off-label communication of Vacepa , Pacira Pharmaceuticals has filed a First Amendment challenge to the FDA’s attempt to restrict communications about its postsurgical pain drug, Exparel. Pacira’ s lawsuit, […]

HRSA 340B Drug Discount Program “Omnibus” Regulation Published – Comment Period Open Until October 27, 2015

On Friday, August 28, 2015, the U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) proposed its long-awaited “Omnibus” regulation for the 340B Drug Discount Program in the Federal Register (the “Proposed Rule”).  The 340B Drug Discount Program is the program by which drug and biologic […]

Kim Kardashian Drug Endorsement Results in FDA Warning Letter

The U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued a Warning Letter this week to Duchesnay, Inc. related to celebrity Kim Kardashian’s social media posts on Instagram, Twitter and Facebook regarding the company’s drug, DICLEGIS. In the posts, Kardashian states that she is “partnering with Duchesnay […]

OIG Releases New Guidance for Board Oversight of Corporate Compliance Programs

Earlier today, the U.S. Department of Health and Human Services Office of Inspector General (OIG), in conjunction with the American Health Lawyers Association (AHLA), the Association of Healthcare Internal Auditors (AHIA) and the Health Care Compliance Association (HCCA), announced the release of a guidance document titled, “Practical Guidance for Health Care […]

OIG Releases Special Advisory Bulletin and Report on Copayment Coupons

Earlier this week, the U.S. Department of Health and Human Services Office of Inspector General (OIG) released a Special Advisory Bulletin titled, Pharmaceutical Manufacturer Copayment Coupons (Bulletin), and a report titled, Manufacturer Safeguards May Not Prevent Copayment Coupon Use for Part D Drugs (Report).  Copayment coupons are offered by pharmaceutical manufacturers in many […]

AMA Tackles Conflicts of Interest with Industry

Interactions between health care professionals and industry representatives was a key topic at the American Medical Association (AMA) House of Delegates (HOD) meeting this week. As reported in BNA today (subscription required), the AMA HOD supported a resolution on June 9th that seeks greater consistency among conflicts of interest policies […]

Resource Launch: Introducing Cooley’s Government Settlements Tracker

Cooley has added an exciting new resource to our blog: the Government Settlements Tracker.  This tracking chart provides an overview of select government settlements related to pharmaceutical, biotechnology and medical device manufacturers, including the settlement amount, whether the matter is civil and/or criminal, whether the matter resulted from a whistleblower action, resolution of the matter, and […]