Prescription Drugs

News & Analysis as of

A “Too Old” OTC Product Does Not A Class Action Make

This past weekend, we attended a fundraising 5K race organized by a friend who lives with a form of muscular dystrophy. We volunteered to photograph the event, because the usual photographer was not able to attend. And...more

FDA Files Brief Regarding Off-Label Promotion In Amarin Pharma Lawsuit

As we mentioned in our prior post, the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit pending in the Southern District of New York raises interesting issues regarding the First Amendment and how it...more

FDA Reports Results of Annual Crack Down on Illegal Internet Pharmacies

Last week, FDA announced that more than 1,050 websites had illegal drugs and devices seized or received warning letters as part of the Eighth Annual International Internet Week of Action (IIWA). IIWA is an international...more

Federal Circuit Tackles Claim Construction Review under New Standard

The More Things Change (Lighting Ballast Control LLC v. Philips Electronics North America), the More They Stay the Same (Teva Pharmaceuticals USA, Inc. v. Sandoz Inc.) - On June 18, 2015, the Federal Circuit handed down...more

MedPAC Report to Congress on Medicare and the Health Care Delivery System

The Medicare Payment Advisory Commission (MedPAC) has released its June 2015 Report to the Congress on Medicare and the Health Care Delivery System. The report includes a series of recommendations on Medicare hospital...more

Obama Administration Announces Record Medicare Strike Force "Takedown"

On June 18, 2015, HHS Secretary Sylvia M. Burwell and Attorney General Loretta E. Lynch announced that a nationwide Medicare Fraud Strike Force sweep resulted in health fraud charges against 243 individuals involving...more

No Prescription For Consumer Protection

Allowing plaintiffs to pursue claims under consumer protection statutes in prescription medical product liability litigation is trying to pound a square peg into a ham sandwich. It doesn’t fit, and the combination isn’t very...more

MedPAC Releases June 2015 Report to the Congress

The Medicare Payment Advisory Commission (MedPAC) released its “Report to the Congress: Medicare and the Health Care Delivery System” on June 15, 2015. As previously reported, the report makes recommendations for policy...more

G.D. Searle LLC v. Lupin Pharmaceuticals, Inc. (Fed. Cir. 2015)

Over seven years ago, the Federal Circuit delivered a mixed ruling against Pfizer in litigation against Teva) relating to the pain medication Celebrex® (celocoxib) (where "celocoxib" is...more

Federal court blocks rule restricting telemedicine practice in Texas

A federal court has temporarily enjoined the Texas Medical Board (TMB) from implementing and enforcing a rule restricting the practice of telemedicine pending resolution of an antitrust lawsuit filed by Teladoc, Inc. The...more

Biosimilars Coding & Reimbursement Significance under Medicare Part B

On April 15, 2015, CMS issued a preliminary recommendation for a HCPCS code for Zarxio, the first biosimilar product ever to be approved by the FDA. CMS’s recommendation provides the first indication of how the agency will...more

Louisiana Appellate Court Overturns Improper Application of “Law of the Case” Doctrine

Today is the day when we will learn whether the Governor of Louisiana will enter the 2016 presidential race. That reminds us of Louisiana’s rather colorful collection of politicians, including Huey Long and Edwin Edwards....more

Public Statements Made by Pharmaceutical and Biotech Company Executives May Raise FDA’s Hackles if They Do Not Meet Basic...

For players in the highly regulated pharmaceutical and health care industries, it is common knowledge that manufacturers and distributors of FDA-regulated products are required to promote their products in compliance with the...more

340B Update: HRSA Proposes Penalties for Drug Manufacturers that Overcharge Covered Entities

On June 16, 2015, the U.S. Department of Health and Human Services (“HHS”) and the Health Resources and Services Administration (“HRSA”) released proposed rules on civil monetary penalties and drug ceiling prices under the...more

Court Report - June 2015 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Mayne Pharma International Pty Ltd. v. Merck & Co., Inc., et al. 1:15-cv-00438; filed May 29, 2015 in the District Court...more

June Xarelto Update – Science Day

Judge Fallon, the federal judge in New Orleans who oversees the MDL coordinated proceedings, held his most recent hearing for all of the pending Xarelto lawsuits on June 10, 2015. At that time, the judge was provided with a...more

HRSA Issues 340B Drug Discount Program Civil Money Penalty Proposed Rule

On June 17, 2015, the Health Resources and Services Administration (HRSA) issued a proposed rule to implement civil money penalty (CMP) provisions added to section 340B of the Public Health Service Act as part of the...more

Tightening Control over Prices for Crucial Medicines

Governmental regulation of vital and essential medicines (hereinafter Essential Drugs) in the Russian Federation in the form in which it exists today has been functioning since 2010. The list of Essential Drugs (“EDL List”)...more

HRSA Takes its First Steps on 340B Rules

The 340B Drug Discount Program has operated for more than 20 years with just a few governing regulations codified in 42 CFR Part 10. Through the Affordable Care Act (“ACA”), Congress adopted several amendments to the 340B...more

ISBE Releases New Guidance on Medication Administration in Schools

In April, the Illinois State Board of Education (ISBE) amended its 2010 guidance on self-administration of medication. Specifically, the new guidance document focuses on recent updates to Section 22-30 of the School Code (105...more

China Issues New Guiding Opinions for Public Hospital Reform

Recently, the General Office of the State Council published the Guiding Opinions on Pilot Comprehensive Reform of Urban Public Hospitals, which took effect on 6 May 2015. The Guiding Opinions give directions for the ongoing...more

Health Update - June 2015

Examining Fee Splitting Statutes in the Context of Value-Based Healthcare - Editor’s note: One of the goals of the Affordable Care Act (ACA) is to align incentives among provider communities and their patients and...more

Health Alert (Australia) - June 22, 2015

In This Issue: - Judgments; Legislation; and Reports. - Excerpt from Judgements: Victoria. Inquest Into the Death of Baby Chloe Lee Kellett - The Victorian Coroner investigated an infant's death from...more

TelaDoc Wins Injunction Against Texas Medical Board re: Telehealth Restrictions

The Federal District Court of the Western District of Texas has ruled against the Texas Medical Board and granted TelaDoc’s Motion for a Preliminary Injunction prohibiting the Texas Medical Board from enforcing new rules...more

Blog: FDA Launches New REMS Website

The U.S. Food and Drug Administration (FDA) launched this week REMS@FDA, a Risk Evaluation and Mitigation Strategy (REMS) database website. The new, user-friendly website contains a table of all currently approved individual...more

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