Prescription Drugs

News & Analysis as of

Accidents Caused by Driving on Prescription Medication

Many of us, for one reason or another, end up taking prescription medications at some point in time. Unfortunately, fewer drivers consider how prescription medications affects their ability to safely drive. New research...more

Xarelto Cases Present Several Common Issues

In July 2011, the Federal Drug Administration (FDA) approved Xarelto, an oral anticoagulant prescribed for prevention of deep vein thrombosis, pulmonary embolism, and strokes in patients with atrial fibrillation. Based on...more

Washington Healthcare Update

This Week: Bipartisan, Bicameral Permanent SGR Fix Introduced... House Budget Committee Advances FY2016 Budget Proposal... National Coverage Determinations Proposed for Removal... HHS Releases Proposed Rules on EHR Incentive...more

Health Alert (Australia) - March 23, 2015

In This Issue: Judgments; Legislation; and Reports. Excerpt from Reports: New South Wales (NSW). Ministry of Health - Media Releases - 18 March 2015 - NSW says protect against mosquitoes after huge...more

RESCHEDULED: 340B in the Spotlight: Congress Offers Webcast of Upcoming Hearing Regarding the 340B Drug Pricing Program

The House Energy & Commerce Health Subcommittee on Health hearing entitled, “Examining the 340B Drug Pricing Program”, originally scheduled for Thursday, March 5th has been RESCHEDULED for March 24, 2015 at 10:00 a.m. EST. ...more

GAO Calls for Expanded HHS Efforts to Reduce Antipsychotic Drug Use in Community Settings

The Government Accountability Office (GAO) has issued a report examining the extent to which antipsychotic drugs are prescribed for older adults with dementia in nursing homes and other settings. ...more

Notes From The Off-Label Underground

Keeping track of litigation over off-label use/promotion frequently sends us off on tangents. We’ve wandered into abortion cases, securities law cases, criminal cases – even cases brought by criminals....more

An Exemplary "Learned Intermediary" Win for Lilly and Byetta

A tip of the hat to our friend and former colleague Ken Zucker from Pepper Hamilton, who achieved this victory and sent us the decision. In the consolidated California Byetta litigation, 2015 WL 663211 (Cal. Super. Feb. 26,...more

Also In The News - Health Headlines - March 2015 #2

Committee on Energy and Commerce Subcommittee on Health Hearing Regarding 340B Drug Pricing Program – On Thursday, March 5, 2015, the Subcommittee on Health, chaired by Rep. Joe Pitts (R-PA), is holding a hearing titled...more

Health Law Wire: E-Prescribing Mandate (3/15)

New York State Governor Andrew Cuomo signed an extender for the electronic prescription mandate late last week, pushing the compliance date to March 27, 2016. The law generally provides that “no person shall issue any...more

A Change of Pace for Product Liability Class Actions: Certification Denied in Two Recent Cases

Oft-referred to as “quintessential class actions”, the majority of product liability actions that have sought certification as class proceedings in the last 10 years have been granted certification. However, two recent...more

FDA Establishes Docket for Public Comments on Drug Compounding

The Food and Drug Administration (FDA) recently announced a new docket for public comments on the compounding of human drug products under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FFDCA). The FDA...more

New FDA Guidance Opens the Door for Electronic Consent Forms That Come with Significant Advantages and Raise Privacy and Secure...

On March 9, 2015, the U.S. Food and Drug Administration (FDA) published a draft guidance that allows for the use of electronic informed consent (eIC) in human clinical trials. eICs have the potential to...more

Health Alert (Australia) - March 16, 2015

In This Issue: Judgments; Legislation; and Publications & Reports. Excerpt from Publications & Reports: American Medical Association (AMA) - 12 March 2015 - New AMA, CDC Initiative Aims to 'Prevent...more

Prescriptions for the Headache of High Cost Drugs

A March 11 policy conference in Washington produced some creative thinking about the problem of high-cost specialty drugs. And on the same day, the RAND Corp. think tank released a study on the subject, “Borrowing for the...more

Dangers of Testosterone Replacement Therapy

The use of testosterone supplements among American men has skyrocketed in recent years. In fact, almost 3 percent of American men over the age of 40 have been prescribed some form of testosterone therapy and, according to...more

CMS Releases April 2015 Medicare Part B Drug ASP Update

CMS has posted its April 2015 update to the Medicare average sales price (ASP) drug pricing files, which contain the payment amounts CMS will use to pay for Part B covered drugs for the second quarter of 2015....more

Going Paperless: FDA Releases Draft Guidelines to Digitize Clinical Trials

The FDA released draft guidelines (“Guidelines”) on Monday, March 9, 2015 establishing recommendations on the use of e-media and processes to obtain informed consent for clinical investigations (trials) of medical products...more

FDA Approves First US Biosimilar but Court Action Could Delay Market Entry

On March 6, 2015, the U.S. FDA announced that it had approved Zarxio, making Sandoz the first company ever to obtain approval of a biosimilar product in the U.S. The FDA deemed Zarxio to be biosimilar to Amgen’s Neupogen...more

OIG Repeats Calls for Expanded Medicare Part B Drug Price Substitution Policy

The OIG has issued the latest in a long line of reports comparing Medicare Part B drug average sales prices (ASP) and average manufacturer prices (AMP), this time with a focus on 2013 pricing. By way of background, CMS has...more

Washington Healthcare Update

1. Congress - House - House Republican Working Group Outlines King v. Burwell “Off-Ramp” Plan The House Republican Health Care Working Group has released an outline of policies they would support if the...more

Health Alert (Australia) - March 9, 2015

In This Issue: Judgments; Legislation; and Reports. - Excerpt from Judgments: Australia. Federal Court - 5 March 2015 - Australian Nursing and Midwifery Federation v Kaizen Hospitals (Essendon) Pty Ltd...more

InterConnect - Winter/Spring 2015

In this Issue: - Between a Rock and a Hard Place: Employers Must Walk a Narrow Path to Comply with DOT and EEOC Directives - New FDA Guidance for 3PLs on License Reporting Under the DSCSA - Moving Ahead in...more

Mother Nature Axes 340B Hearing, But Written Testimony Survives

Mother Nature claimed another victim this week. The U.S. House of Representatives Energy and Commerce Subcommittee on Health was scheduled to hold a hearing on March 5, 2015 – Examining the 340B Drug Pricing Program. But...more

Advertising Law - March 2015

NAD: A Product Can’t be The “#1 Prescribed Brand” Without Other Prescribed Brands - A “#1 brand prescribed” claim implies that professionals have a choice in prescribing brands, the National Advertising Division...more

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