Prescription Drugs

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Health Care Update - August 2014 #3

In This Issue: - Stakeholders Urge FDA to Provide Clarity on Biosimilars - Ebola Crisis Continues - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other...more

Socially Aware - Volume 5, Issue 5 - August 2014

In This Issue: - Data for the Taking: Using the Computer Fraud and Abuse Act to Combat Web Scraping - Google Glass Into Europe: A Small Step or a Giant Leap? - Drugs and the Internet: FDA Distributes New...more

FDA Releases Another Prospective Guidance

On August 5th, the U.S. Food and Drug Administration issued a "Guidance for Industry" entitled "Reference Product Exclusivity for Biological Products file under Section 351(a) of the PHS Act." Before setting forth the first...more

Discount Drug Program Passes OIG Scrutiny

On July 28th, 2014, the Department of Health and Human Services, Office of Inspector General (OIG) released favorable advisory opinion 14-05, concluding that a pharmaceutical manufacturer’s direct-to-patient discounted, cash...more

Purdue Pharm. Products, L.P. v. Actavis Elizabeth, LLC (D.N.J.)

Plaintiffs hold an NDA covering tablets containing two strengths of zolpidem tartrate, which is used in the treatment of middle-of-the-night insomnia. In July 2013, TWi Pharms., Inc. (“TWi”) submitted an ANDA containing a...more

OIG Approves Manufacturer’s Direct-to-Patient Discount Sales Program

The Office of Inspector General (“OIG”) recently posted an Advisory Opinion approving a pharmaceutical manufacturer’s direct-to-patient product sales program. While this Advisory Opinion cannot be relied upon by anyone other...more

Federal Circuit Finds That FDA Citizen Petition Could Give Rise to Antitrust Liability

In Tyco Healthcare Group LP v. Mutual Pharmaceutical Co., Inc., the Federal Circuit remanded-in-part for the district court to determine whether Tyco’s citizen petition to the FDA gave rise to antitrust liability. Judge...more

MoFo BioMeter - Vol. 3, Issue 3, August 2014 - Q2 Biometer Shows Strong Value In Drug Discovery Platforms

The average BioMeter value in the second quarter of 2014 jumped significantly to $143.4 million, an increase from the $15.9 million value in the first quarter. This included two blockbuster deals, the $1 billion up front paid...more

CMS Retracts Hospice Preauthorization Requirements for Part D Drugs

On July 18, CMS released new guidance retracting a major portion of its controversial preauthorization requirement for hospice beneficiaries. The new guidance supersedes portions of the March 10, 2014 guidance [PDF] that...more

The Future of Coverage and Payment for Personalized Medicine Diagnostics

The past decade has seen incredible progress for the scope and impact of personalized medicine. Just ten years ago, tamoxifen and trastuzumab were among the few drugs that were routinely paired with a companion diagnostic...more

FDA Issues Draft Guidances for Prior Approval Supplements and Amendments / Easily Correctable Deficiencies Under GDUFA

The Generic Drug User Fee Amendments of 2012 (GDUFA) were signed into law on July 9, 2012, in an effort "to speed access to safe and effective generic drugs to the public and reduce costs to industry." In July 2014, the U.S....more

FDA Issues Updated Draft Guidance on Reporting Drug Samples

The guidance calls for 2014 reporting by April 1, 2015. When signed into law in March 2010, the Affordable Care Act (ACA) put a renewed focus on transparency. While section 6002, the Physician Payment Sunshine Act,...more

Prometheus Labs., Inc. v. Roxane Labs., Inc. (D.N.J.)

Lotronex was initially launched in 2000, but was subsequently removed from the market in light of serious side effects attributed to the drug. It was re-launched in 2002 with a new label. At the time, the ’770 patent was...more

FDA Issues Draft Guidance on 510(k)

The FDA issued a new draft guidance on July 15th which further explains how the FDA currently fails to protect consumers of medical devices and pharmaceutical drugs. It is important to remember that these sort of FDA-issued...more

The Commission Fines Servier And Five Generic Companies For Curbing Entry Of Cheaper Versions Of Cardiovascular Medicine

The European Commission has imposed fines totalling €427.7 million on the French pharmaceutical company Servier and five producers of generic medicines – namely, Niche/Unichem, Matrix (now part of Mylan), Teva, Krka and Lupin...more

Employee Benefits Developments - July 2014

In May 2014, the Departments of Labor (DOL), Health and Human Services (HHS), and Treasury issued Frequently Asked Questions (FAQs) Part XIX, addressing, among other subjects, the following: The newly revised DOL model...more

OIG Reports that Two MACs are Responsible for $4 Million in Overpayments for Outpatient Drugs

According to two reports issued by OIG on July 25, the Medicare Administrative Contractors (MACs) for Jurisdictions 13 and 14 made overpayments of approximately $2.7 million and approximately $1.3 million, respectively, for...more

Court Report -- Part II - July 2014 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Acorda Therapeutics Inc. v. Actavis Laboratories FL Inc. 1:14-cv-00882; filed July 7, 2014 in the District Court of...more

HHS Issues Interpretive Rule Excluding Orphan Drugs from 340B Program Discounts Only for Designated Orphan Status Uses

On July 21, 2014, the Health Resources and Services Administration of HHS (HRSA) issued an interpretive rule interpreting Section 340B(e) of the Public Health Service Act as excluding from the 340B Drug Pricing Program orphan...more

Sanofi-Aventis Deutschland GmBH v. Glenmark Pharms. Inc. (Fed. Cir.)

Case Name: Sanofi-Aventis Deutschland GmBH v. Glenmark Pharms Inc., 748 F.3d 1354 (Fed. Cir. Apr. 21, 2014) (Circuit Judges Newman, Linn and Wallach presiding; Opinion by Newman) (Appeal from D.N.J., Cavanaugh,...more

FDA Accepts First Biosimilar Application under New Approval Pathway

July 24, 2014 was a landmark day in the biotechnology industry: Sandoz (the generic arm of Novartis) announced that the U.S. Food and Drug Administration (FDA or “the Agency”) had accepted the first application for a U.S....more

Finally, A Biosimilar Application Has Been Accepted By The FDA

In what is thought to be the first application accepted under the new biosimilar pathway created by the Biologics Price Competition and Innovation (BPCI) Act, Sandoz announced last Thursday that the U.S. Food and Drug...more

Is Off-Label Drug Promotion Protected Free Speech?

It is a very common practice. Drug sales reps visit a client, usually a hospital, a clinic or a doctor, with the sole purpose of selling a drug or medical device. That is the primary way a doctor learns about a drug or...more

Health Headlines: Also in the News - July 2014 #3

CMS Revises Medicare Advantage and Part D Prescription Drug Plan Prior Authorization Requirement for Hospices – On July 18, 2014, CMS released a revised a memorandum outlining responsibility for drug payments for hospice...more

Drugs and the Internet: draft guidance on social media platforms and prescription drugs

The Food and Drug Administration (FDA) recently promulgated two much-anticipated draft guidance documents on the use of social media to present information about prescription drugs and medical devices. The draft guidance...more

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