Prescription Drugs

News & Analysis as of

Comparison Shopping for Medicare Drug Coverage

For many people, autumn is the season for enrollment in a medical insurance plan. Everyone, whether you’re 25 or 85, whether you’re covered through an employer plan, a state insurance exchange, private insurance or Medicare,...more

Massachusetts Legislature Takes Action on Opioid Crisis

Amid a recent surge in opioid-related deaths in Massachusetts, with over 1,200 accidental deadly overdoses last year, the Senate passed legislation on Thursday, October 1, that is designed to fight the epidemic on various...more

Health Alert (Australia) - October 5, 2015

In This Issue: - Judgments; Legislation; and Reports. - Excerpt from Judgments: Victoria. Epichealth Pty Ltd v Yang [2015] VSC 516 The Supreme Court has granted an interlocutory...more

Health Law Pulse - October 2015

The Health Resources and Services Administration (HRSA) recently issued proposed omnibus guidance (Omnibus Guidance) interpreting various provisions of the 340B Drug Pricing Program (340B Program). The 340B Program allows...more

Cymbalta Judge Severs Claims and Smacks Down Plaintiff Lawyers’ Self-Created "Quagmire"

Ninety-nine years ago today (October 7) Georgia Tech administered the most lop-sided beat-down in college football history, edging Cumberland University 222-0. (By the way, who was the head coach of Georgia Tech who presided...more

Change Coming to FDA’s “Intended Use” Regulations?

Over at the Drug And Device Law Blog, our colleagues call attention to proposed changes to the “intended use” regulations for prescription drugs and devices, 21 C.F.R. §201.128 and 21 C.F.R. §804.1, somewhat hidden within a...more

Another Decision Applying Bartlett Preemption to All Drugs

Just last month we collected all the favorable precedent applying impossibility preemption under Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), to innovator drugs – although the precise subject of that post...more

MedPAC Meeting on Medicare Policies (Oct. 8-9)

The next Medicare Payment Advisory Commission (MedPAC) meeting is scheduled for October 8 -9, 2015. Topics on the agenda include: Medicare drug spending; Alternative Payment Models and the Merit-based Incentive Payment...more

Washington Healthcare Update

This Week: Congress Avoids a Government Shutdown... House and Senate Approves Measure to Expand the Affordable Care (ACA) Act Small Group Market to 100 Employees...Affordable Care Act (ACA) Health Insurers to Receive Only...more

Bristol-Myers Squibb FCPA Enforcement Action

Yesterday, the Securities and Exchange Commission (SEC) announced a Foreign Corrupt Practices Act (FCPA) enforcement action against Bristol-Myers Squibb Company (BMS) for the actions of the company’s joint venture (JV) in...more

Trans-Pacific Partnership agreement on term of data exclusivity for biological pharmaceuticals, not patent term

Five years of negotiations have culminated this week in the signing of the Trans-Pacific Partnership (the “TPP”) agreement by 12 countries from the Pacific-rim region, including the US and Australia. While the partnership...more

M.D. Fla. Shuts Down Attempted End-Run Around Learned Intermediary in Enbrel Case

Today’s case gives us a lesson and a laugh. The lesson is that a court can be persuaded to prevent enterprising plaintiff lawyers from turning warning adequacy and the learned intermediary rule into not-so-funny jokes. The...more

HHS Issues Proposed 340B Program Omnibus Guidance: Five Things to Watch

The 340B Drug Pricing Program (340B Program), established by Section 602 of the Veterans Health Care Act of 1992, is administered by the Health Resources and Services Administration (HRSA) of HHS. The 340B Program requires...more

Blog: Joining the Debate, Hillary Clinton Releases Plan to Curb Drug Prices

In the wake of the uproar about drug pricing, Hillary Clinton unveiled on Tuesday, a plan to address the rising cost of prescription drugs. The plan will focus on ending “excessive” profits, lowering out-of-pocket costs,...more

Lions and Tigers and Bears, Oh My! The Unexpected Laws that May Affect Your Telehealth Business

An increasing number of health care providers are exploring telemedicine, either as an adjunct to their primary physical practice or as a separate and new venture. Providers have determined that many aspects of the service...more

The FDA Takes the Kardashian Endorsement Machine to Task

When Kim Kardashian speaks, the FDA listens. Or, more precisely, when Kardashian, who has 46.8 million followers on Instagram, posts an enthusiastic endorsement—and advertisement—on the social media platform for Diclegis, a...more

Breaking News - Arizona Supreme Court to Review Watts Learned Intermediary decision

We've posted previously about the awful learned intermediary decision by the Arizona Court of Appeals in Watts v. Medicis Pharmaceutical Corp., 342 P.3d 847 (Ariz App. 2015). Well, that's not the last word anymore. Today...more

SDNY Sacks Treanda Failure to Warn Claim

Failure to warn cases remind us of sports talk radio and paleontology. Especially on Monday mornings in the Fall, Philly sports talk radio is a festival of woe and recrimination. The Iggles are terrible, their deficiencies...more

Pharma and Medical Device Industry Victory in Off-Label Marketing Decision

The U.S. District Court for the Southern District of New York recently held that the FDA may not constitutionally bring a misbranding action based on truthful and non-misleading off-label promotion of an FDA-approved drug,...more

Mintz Levin Health Care Qui Tam Update: Recent Developments & Unsealed Cases - September 2015

Trends & Analysis - Since our last Qui Tam Update, we have identified 39 health-related False Claims Act (“FCA”) qui tam cases that have been unsealed. Of those cases...more

Massachusetts Legislature Advances Bill to Impose Caps on Drug Prices

The Joint Committee on Health Care Financing of the Massachusetts legislature took up Bill S. 1048, an "Act to promote transparency and cost control of pharmaceutical drug prices," on Sept. 14, 2015. The bill initially was...more

Drug and Device Companies May Soon Face Less Burdensome FDA Approval Process

On July 10, 2015, Congress passed H.R. 6, the 21st Century Cures Act, with a bipartisan vote of 344 to 77. The 352-page bill seeks to make the U.S. Food and Drug Administration (FDA) drug and device approval process less...more

Arizona Supreme Court Poised to Consider “Learned Intermediary” Doctrine

The Arizona Supreme Court will soon decide whether to grant or deny review of the Court of Appeals’ January 2015 decision regarding the longstanding “learned intermediary” doctrine. In January, the lower court held that the...more

Another No Show For Personal Jurisdiction In The Show Me State

We have previously expressed our surprise that personal jurisdiction has so quickly become such an effective bulwark against the forum abuse that we call litigation tourism. Our surprise is modest, mind you, since the recent...more

Solid "No Designer Liability" Decision in a Non-Pharma Case in the Eastern District of Pennsylvania

On September 13th, we, as Drug and Device Law Jews, celebrated Rosh Hashanah, the Jewish New Year. Normally, we host dinner for 20 or so members of our extended family. This year, the entire day before the holiday was...more

925 Results
View per page
Page: of 37

"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 to create your digest using LinkedIn*

*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.