Prescription Drugs

News & Analysis as of

Generic’s Counterclaims for Non-Infringement are Proper Despite Covenant Not to Sue From Brand

On April 9, 2014, in Purdue Pharmaceutical Products, L.P. v. TWi Pharmaceuticals, Inc., Civ. No. 12-5311 (D.N.J.), Judge Jose L. Linares of the United States District Court for the District of New Jersey ruled that a generic...more

Hoffman-La Roche Inc. v. Apotex Inc. (Fed. Cir. 2014)

Last Friday, the Federal Circuit issued an opinion in Hoffman La-Roche Inc. v. Apotex Inc. that is a cautionary tale of patent lifecycle and the difficulties those seeking to extend patent protection face -- namely the...more

Alabama Man Faces Murder Charge After Causing Fatal Accident

When an Alabama driver makes the decision to get behind the wheel under any impairment, a fatal accident may be a harsh possibility. Driving requires a person's vigilance, and being impaired severely reduces that. ...more

FDA Seeks Information for Implementation of Drug Supply Chain Security Act

On November 27, 2013, the Drug Supply Chain Security Act (DSCSA) was enacted "to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed within the United States." To...more

Indiana Governor Signs Biosimilar Substitution Bill

On March 25, Indiana Governor Mike Pence signed legislation (Senate Bill 262) that will allow pharmacists in Indiana to substitute an interchangeable biosimilar product for a prescribed biological product if certain...more

Two Recent 340B Developments: New Hospital Registration Guidance and Proposed Rules Under Review at OMB

Earlier this week, the much-anticipated 340B Drug Pricing Program (340B Program) proposed rule arrived at the Office of Management and Budget for review. Publication of this proposed rule is expected in June and will likely...more

Insurance Recovery Law

Suit Alleging Drug Distributor Was a “Pill Mill” Requires Defense - Why it matters: A Kentucky federal court held that the claimed impact in a suit brought by the West Virginia Attorney General – alleging that...more

Public Citizen Wants Black Box on Testosterone Products

There appears to be no shortage of advertising for testosterone products for men to relieve low sex drive and fatigue. But these products remain without any warning on the product labels despite a recent study that showed the...more

Global Food, Drugs, Medical Devices and Cosmetics Newsletter

Welcome - We are pleased to provide you with the Spring edition of the Global Food, Drugs, Medical Devices and Cosmetics newsletter. As stated in our inaugural issue, this newsletter provides updates on important...more

Endo Pharmaceuticals Inc. v. Actavis, Inc. & Endo Pharmaceuticals Inc. v. Roxane Laboratories, Inc. (Fed. Cir. 2014)

The Federal Circuit's decision in the consolidated appeals of Endo Pharmaceuticals Inc. v. Actavis, Inc. and Endo Pharmaceuticals Inc. v. Roxane Laboratories, Inc. amply demonstrates the concept that you should be careful...more

HEB Grocery Company Agrees to Pay $12 Million to Settle Texas Medicaid Fraud

On March 17, 2014, a Texas state court dismissed a qui tam lawsuit against HEB Grocery Co. after HEB reach an agreement with the Texas Attorney General’s Civil Medicaid Fraud Division to pay a combined $12 million to settle...more

Tri-Agency Health IT Report Issued

Today, the three federal agencies charged with regulating components of health information technology (“Health IT”) issued their long-awaited Health IT Report: Proposed Strategy and Recommendations for a Risk-Based Framework...more

Trustee Alert – Final Mental Health Parity Rules

The Mental Health Parity rules require group health plans that offer mental health and substance use disorder benefits to cover those benefits on terms that are no more restrictive than those applied to comparable medical and...more

FTC Continues Aggressive Posture On Reverse Payment Settlement Agreements With Reference To Disgorgement

In two recent statements, the FTC reaffirmed its intention aggressively to pursue reverse-payment patent settlement agreements in the pharmaceutical industry. ...more

Congressional Hearing on Proposed FDA Rule Change

Yesterday afternoon, Congress’s Subcommittee on Health held a hearing to examine the FDA’s proposal to change the rules of generic drug labeling....more

Health Care on the Hill: April 2014

House Committee on Energy and Commerce – Subcommittee on Health - “Examining Concerns Regarding FDA’s Proposed Changes to Generic Drug Labeling” - April 1, 2014 – 3:00pm - 2322 Rayburn House Office...more

MoFo BioMeter - Vol. 3, Issue 1, March 2014 - Q4 and FY 2013 BioMeter Shows Rebound in Value for Late Stage Products and Strong...

The full-year 2013 BioMeter analysis shows across-the-board increases in BioMeter value, with an average of $33.9 million for all transactions, up from approximately $21.2 million in 2012. Increases occurred for each stage of...more

Advertising Law

FDA “Dislikes” Drug Company’s Facebook Page - Switzerland-based IBSA Institut Biochimique SA recently got a thumbs-down from the Food and Drug Administration over a Facebook ad for its hypothyroidism drug, Tirosint,...more

J&J Gets $1.2 Billion Pass on Risperdal Fine

Two years ago, healthcare giant Johnson & Johnson was facing a $1.2 billion judgment after a jury determined J&J concealed the risks of its antipsychotic drug Risperdal while it aggressively and improperly marketed it...more

Recent FDA Social Media Marketing Enforcement Actions and the Likely Impact of Social Media Promotion Guidance

In recent years, guidance by the U.S. Food and Drug Administration ("FDA" or "Agency") for industry on the use of social media has continued to evolve in incremental steps, but the pharmaceutical and medical device industries...more

GEN and FiercePharma Compile Lists of Top Selling Drugs for 2013

Earlier this month, Genetic Engineering & Biotechnology News released its list of the top 25 best-selling drugs worldwide for 2013. GEN's list, which the journal released on March 3 (see "The Top 25 Best-Selling Drugs of...more

HHS and GAO Reports Highlight Need to Address Drug Shortages

Two recently released reports from the U.S. Department of Health and Human Services (HHS) and the U.S. Government Accountability Office, respectively, focus on the impact of prescription drug shortages, their potential causes...more

California Supreme Court To Consider Causation in Workers Comp for Medication-Related Injuries

In Wednesday’s conference, the California Supreme Court agreed to review South Coast Framing v. Workers’ Compensation Appeals Board, an unpublished decision from Division One of the Fourth District. South Coast Framing poses...more

FDA Draft Guidance Proposes Change to Combination Product Exclusivity Policy

New market exclusivity opportunities emerge for pharmaceutical companies. In draft guidance released by the Food and Drug Administration (FDA or the Agency) on February 24, 2014, the Agency proposed changes to its...more

Living off the Label

Doctors and physicians are given a great deal of discretion when it comes to prescribing drugs for uses other than those indicated by the FDA. This is known as “off-label” use. The FDA, realizing the danger of off-label...more

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