Pharmaceutical Industry Healthcare

News & Analysis as of

White Collar Crime Law Enforcement in a Trump Justice Department - 8 Predictions

After a conventional presidential campaign, determining the policy priorities and direction of the incoming administration with respect to the Justice Department’s white collar law enforcement responsibilities can be a...more

Second Circuit Affirms Preliminary Injunction of "Identical" Gray Goods

Earlier this month in Abbott Laboratories v. Adelphia Supply USA et al, the Second Circuit affirmed a district court's grant of a preliminary injunction halting the alleged sale of gray-good diabetes test strips made by...more

Recent Developments around Pharmaceutical Drug Spending in Massachusetts

Throughout the fall, policy makers in Massachusetts have sharpened their focus on the rise of pharmaceutical drug prices and their role in the growth of overall health care spending in the Commonwealth. Both the Center for...more

Three Former Warner Chilcott District Managers Prosecuted for HIPAA Violations

The United States Attorney’s Office for the District of Massachusetts recently announced that three former district managers of the pharmaceutical firm Warner Chilcott have been sentenced for violating the Health Insurance...more

A Trump Presidency: Potential Impact on Employee Benefits Law and Policy

For many months, we have been speculating about how the results of the 2016 presidential election would impact employee benefits policy going forward. Now that Donald Trump has won the election and Republicans have secured a...more

Accepting Anonymous Tips: FDA's Website for Reporting Medical Device Regulatory Misconduct

For device manufacturers and sellers, the website represents another source of information to monitor for possible challenges ahead. Unidentified tipsters — from disgruntled former employees to plaintiffs’ attorneys —...more

New Clinical Trial Rule Alters Reporting Requirements

New federal requirements for posting of clinical trials information address how data collected in clinical trials are submitted for public consumption. The requirements were revealed on Sept. 16 when the Department of Health...more

FDA Launches New Webpage to Report Regulatory Misconduct

Earlier this week, the FDA launched a new webpage to simplify the process of reporting violations of the law by medical device manufacturers and individuals marketing medical devices. Unlike the MedWatch system for reporting...more

The 2016 Election and Your Healthcare System: What’s at Stake?

Regardless of the 2016 general election outcome, a new administration will have to respond to pressing policy issues that will shape continued transformation of the U.S. healthcare system. What are the issues and where do...more

The FDA Implements the Medicare Modernization Act: A New Role and a New Mission?

The Food and Drug Administration (FDA) has finally—after thirteen years—issued its final rule to amend its current regulations and implement the Medical Modernization Act governing how the American public get their generic...more

IVC Filter Litigation – Judge says no to Protective Order

Plaintiffs in a Multi District Litigation (“MDL”) filed complaints against Cook Medical Inc. (“Cook”) and alleges that Cook knowingly presented false information regarding the safety profile of its IVC filters to physician...more

Final Judgment Prescribed For Antibody Patent After Double Patenting Decision

We previously wrote about Judge Wolf’s decision to invalidate Janssen Biotech, Inc.’s (“Janssen”) biopharmaceutical patent (U.S. Patent No. 6,284,471 (the “’471 Patent”)), based on the doctrine of obviousness-type double...more

Stryker Accolade V40 LFIT Hip Implant Dissociation – What Are the Experts Saying?

Over the past few years, various orthopedic surgeons around the country and their patients have been faced with a catastrophic failure of Stryker’s Accolade and V40 LFIT hip implants and incredible challenges for the...more

Taper Failures – A Hot Topic in Orthopedics

After a decade of receiving several black eyes over failed metal on metal implants, the orthopedic device industry is bracing itself for a second wave of metal failure related embarrassment. The metal on metal debacle...more

Donations and Grants in China: Compliance Controls Beyond T&E

While travel and entertainment expenses have presented significant compliance challenges for life sciences companies operating in China, donations and grants can also pose notable compliance risks. China’s escalated...more

Off-Label Promotion —To Speak or Not To Speak?

Earlier this month, the U.S. Food and Drug Administration (FDA) announced a two day public hearing to take place November 9 and 10 aimed at obtaining input from industry to help shape FDA's policy regarding communications...more

The Board of Pharmacy’s 40 Hour Rule is Dead! Long live the 20 Hour Rule! Community Pharmacy Ownership Rule Change Creates new...

The Florida Board of Pharmacy (BOP) recently amended the rules regarding community pharmacy hours of operation to reduce required daily operating hours from 40 to 20 hours per week. As before, the hours have to be posted and...more

New 340B Dispute Resolution Process: Will It Level the Playing Field?

On August 12, HRSA published a formal proposed rule regarding a 340B Drug Pricing Program administrative dispute resolution (ADR) process. HRSA’s use of the administrative rulemaking process is a rare occasion given its...more

Is There Coverage for The Pill Mill Lawsuits?

In an effort to deal with the terrible epidemic of drug abuse and the human and economic costs of this dilemma, the state of West Virginia has brought lawsuits in several jurisdictions against pharmaceutical companies and...more

Healthcare Regulatory Diligence: “What Does it Mean to Financial Underwriting?”

It’s deal time! The 2016 JP Morgan Healthcare Conference has set the tone for another successful year for healthcare investing. A company’s financial health is a key factor in the underwriting process for any type of loan...more

California Imposes Controversial Cost-Sharing Restrictions to Facilitate Patient Access to Expensive Drugs

In response to public discontent over surging drug prices, federal and state lawmakers are scrambling to introduce drug price reform legislation. While many of these reforms have targeted drug manufacturers, a few state...more

Health Alert (Australia) - November 9, 2015

In This Issue: -Judgments; Legislation; and Reports -Excerpt from Judgments Queensland 13 October 2015 - Chaudhry v Medical Board of Australia [2015] QCAT 414 The Queensland Civil and...more

Justice Department Charges Pharma President with Kickback Conspiracy

In the public relations battle following the issuance of the Yates Memo, the Justice Department can now cite one example for the new policy – the recent arrest and charging of Carl Reichel, former President of Warner...more

OMNICARE and its Implications

In the spring of this year, the Supreme Court issued its long-awaited decision in Omnicare, Inc. v. Laborers District Council Construction Industry Pension Fund, 135 S.Ct. 1318 (2015), resolving a circuit split regarding the...more

Three Pressing Challenges for Personalized Medicine

Personalized medicine can be described as the science of targeted therapies. Advances in diagnostic and molecular medicine have made it possible to more precisely identify alternative treatment options for patients based on...more

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