News & Analysis as of

Prescription Drugs

Your Daily Dose of Financial News

by Robins Kaplan LLP on

Europe’s much-ballyhooed (and feared) General Data Protection Regulation (“GDPR”) officially goes into effect today.  Here’s a look at the mad dash across all sectors (and outside of the EU) to comply....more

AGG Food and Drug Newsletter - May 2018

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Say My Name, Say My Name: FDA Posts List of RLD Access Inquiries

by Arnall Golden Gregory LLP on

On May 17, 2018, the Food and Drug Administration posted a list of pharmaceutical manufacturers that FDA alleges have blocked potential generic drug applicants from accessing drug samples needed to obtain approval for their...more

May Highlights: National Healthcare Law News

by Dickinson Wright on

Earlier this month, on May 7, 2018, the Senate passed bipartisan S.B. 1732, entitled the “Improving Access to Behavioral Health Information Technology Act.” The bill, which is currently in the House of Representatives, aims...more

A Wish for Nonexistent Cheap Drugs Is Not Standing to Sue

The recent releases of highly effective, and highly priced, drugs to treat chronic diseases has bred a spate of efforts by activists to disenfranchise drug developers of their patent rights. One recent chapter is instructive,...more

Treatment Center Pleads Guilty to Anti-kickback Statute Violations Involving Alcohol and Drug Addiction Treatment Centers

by Ruder Ware on

The Department of Justice (DOJ) recently announced the guilty plea of two individual alcohol and substance abuse treatment center owners for their participation in what the DOJ labeled a “multi-million dollar health care...more

America’s Opioid Crisis

The Genesis of the Opioid Crisis - The deaths caused by opioids in 2016 exceeded the total deaths in any single year from car accidents, gun violence and even HIV/AIDS at the height of that epidemic. Multiple factors have...more

FDA tries to prod Big Pharma on prices with a new ‘naming and shaming’ list

After critics called President Trump’s long-awaited plan to rein in Big Pharma’s rapacious prices disappointing, his administration launched a much-tried tactic against the industry: “naming and shaming.” The federal Food and...more

UK Parliamentary Report Published on the Impact of Brexit on the Pharmaceutical Sector

by Hogan Lovells on

The Business, Energy and Industrial Strategy Committee, a parliamentary select committee, has published a report on the consequences of Brexit on the UK pharmaceutical industry. ...more

340B Update: President’s Blueprint Includes 340B Reforms, the OPPS Litigation Continues, and Other Recent Developments

by K&L Gates LLP on

The past several weeks have featured a flurry of activity under the 340B Drug Pricing Program (“340B Program”), with recent action in all three branches of the federal government. Notably, on May 11, 2018, the Trump...more

Last Week in 340B: the Revival [not] of the 340B Mega-Guidance, Another Senate Hearing, and the Trump Blueprint to Lower Drug...

On Wednesday May 9th, I was floored when the Administration released the Spring 2018 Unified Agenda of Regulatory and Deregulatory Actions, which contained this nugget: by December 2018, HRSA will publish its 340B Omnibus...more

Health Care Weekly Preview from ML Strategies – May 2018 #3

This week, various health care programs in need of reauthorization will be reviewed by the relevant House and Senate Committees. The Senate will be looking at the Pandemic and All-Hazards Preparedness Act, or PAHPA, and the...more

Derailing the Gravy Train – Trump Unveils Plan to Reduce Drug Prices

Throughout his presidential campaign, President Trump championed the need to allow the government to negotiate drug prices on behalf of the Medicare program. However, that third rail for pharmaceutical companies was not...more

Capitol Hill Healthcare Update

by BakerHostetler on

RYAN SAYS POTENTIAL COMPROMISE COMING ON RISK EVALUATION AND MITIGATION STRATEGY DRUGS - House Speaker Paul Ryan, R-Wis., last week said congressional leaders are trying to hammer out compromise legislation that would make it...more

M.G. Oil (Happy Jack’s Casino) to Pay $45,000 to Settle EEOC Disability Discrimination Case

South Dakota Company Failed to Hire Applicant Because of Prescribed Medication Taken to Treat Her Disability, Federal Agency Charged - SIOUX FALLS, S.D. - M.G. Oil Company, doing business as Happy Jack's Casino, has...more

Health Care Policy Newsletter - May 2018 pt 2

by Foley & Lardner LLP on

Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team is pleased to share our “Public Policy Weekly Health Care Newsletter” in which we compile the latest health care policy news and legislation.*Please note that we...more

HHS Seeks Public Comments on Trump Administration’s Plan to Lower Drug Prices

by Goodwin on

Last week the Department of Health and Human Services (HHS) issued a request for comments on the Trump administration’s plan to lower drug prices. The HHS blueprint to lower drug prices includes improving competition by...more

ITC Institutes Investigation Based on Allegation of Drug Sales Without FDA Approval

by Jones Day on

Normally, it is the FDA that monitors the improper distribution of drugs. But, as it turns out, the International Trade Commission (“ITC”) might be able to enter the fray too. On April 18, 2018, the ITC issued a notice...more

Health Care : Helpful Hints – May 2018

by Burr & Forman on

OIG Issues New Advisory Opinion on May 7, 2018 - The Office of Inspector General (“OIG”) approved a proposed arrangement involving medical devices/supplies. OIG Advisory Opinion No. 18-02 concerns an arrangement where a...more

FDA’s New Pharma Shame Game

by Holland & Knight LLP on

On May 17, 2018, the Food and Drug Administration (FDA) posted a new list targeting pharmaceutical companies that, in the FDA’s view, have used “certain ‘gaming’ tactics to delay generic competition.” The list is intended to...more

Health Care Weekly Preview from ML Strategies – May 2018 #2

With two weeks left in this work period, we are already seeing signals that the House E&C effort to pass an opioid package may spill into June. The House Ways & Means Committee is joining the conversation. On Friday, they...more

DOJ Enters Into Largest-Ever Civil Settlement with Hospital for Drug Diversion

On May 16, 2018, the U.S. Attorney’s Office for the Southern District of Georgia announced that it had entered into the “largest hospital drug diversion civil penalty settlement in U.S. History” in the amount of $4.1 million...more

Recent Fraud Settlements Illustrate Current Compliance Risk Areas

by Ruder Ware on

One of the reasons compliance officers and health care attorneys read fraud settlements is to identify issues the government is focused on. The cases the government decides to pursue are very indicative of the areas of fraud...more

The European Commission Is Considering Opening an Antitrust Probe for Parallel Imports in the Pharmaceutical Sector

by Hogan Lovells on

The European Commission is looking into several parallel imports cases, including in the life sciences industry, with a view to opening formal antitrust investigations, which may eventually lead to fines being imposed....more

Patent law in Europe: What pharmaceutical companies need to know

by Hogan Lovells on

Increasing competition within Europe’s pharmaceutical space makes knowing the market and understanding available patent protections more critical than ever for both well established and new market players. Andreas von Falck...more

2,090 Results
|
View per page
Page: of 84
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.