Prescription Drugs

News & Analysis as of

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Drugs and the Internet: draft guidance on social media platforms and prescription drugs

The Food and Drug Administration (FDA) recently promulgated two much-anticipated draft guidance documents on the use of social media to present information about prescription drugs and medical devices. The draft guidance...more

The Ghosts of Litigation Holds Past

Earlier this year, in the widely followed In re: Actos (Pioglitazone) Products Liability Litigation matter, a Louisiana federal jury ordered a drug manufacturer to pay $6 billion in punitive damages and $1.5 million in actual...more

Recent FDA Draft Guidance Addresses Social Media Challenges Faced by Drug and Device Companies

The first draft guidance discusses how drug and medical device companies may promote their products using character space limited social media (e.g., Twitter) and Internet advertisements (e.g., Google search engine...more

HHS Says It Has Authority to Issue Interpretive Guidance on Contested 340B Orphan Drug Rule Despite Court Order Vacating Final...

According to a recent court filing by HHS, the agency should not be precluded from issuing interpretative guidance regarding a provision of the 340B Drug Pricing Program even though a federal district court previously vacated...more

Product Liability Update - July 2014

In This Issue: - Massachusetts Supreme Judicial Court Holds Foreign Manufacturer Which Pled Meritorious Personal Jurisdiction Defense in Answer, But Did Not Move to Dismiss, Forfeited Defense By Participating in...more

HRSA Issues Interpretive Rule on 340B Drug Pricing Program

On July 21, 2014, the Health Resource and Services Administration (HRSA) within the U.S. Department of Health and Human Services (HHS) issued a new interpretive rule addressing the treatment of orphan drugs by certain...more

FDA Draft Guidance Aims to Clarify Appropriate Character-Space-Limited Social Media Use by Drug and Device Firms: Part One of Two

As technology continues to evolve, so do the ways in which patients and healthcare providers obtain information pertaining to medical products regulated by the Food and Drug Administration (FDA). Thomas Abrams, Director of...more

The Orphan Drug Wars: HHS Interpretive Rule Clarifies Orphan Drug Exclusion

On July 21, 2014, the U.S. Department of Health and Human Services (HHS) released an “Interpretive Rule” in response to a recent U.S. District Court decision that vacated the July 23, 2013, orphan drug rule on the grounds...more

FDA Issues Draft Guidance on Communications Over Internet and Social Media Platforms

On June 17, 2014, the U.S. Food and Drug Administration (FDA or the Agency) issued two draft guidance documents, providing recommendations for two types of communication over internet and social media platforms. The first...more

Has Codeine Harmed Your Child?

In August 2012, the U.S. Food and Drug Administration (FDA) issued a boxed warning — its strongest — to alert doctors and parents about the risks of administering codeine to children post-surgery. According to the FDA,...more

FDA Proposes Guidelines for Posting Medical-Product Information Online

A lot can be misconstrued in the silent world of the Internet. While online technology has changed the communications paradigm, it also has resulted in bad information, embarrassing typos, factual errors and malfeasance....more

FDA Hosts Webinar Addressing Social Media Draft Guidance

The Food and Drug Administration hosted a Social Media Draft Guidance Webinar. The July 10 webinar included summary review of the three draft guidances issued this year to date followed by a brief Q&A. Thomas Abrams, director...more

You Are Now on the Clock — Sunshine Act Dispute Window Now Open

Beginning Monday, July 14, 2014, the review, dispute and correction process outlined the National Physician Payment Transparency Program (also known as the "Sunshine Act") opens on CMS's Open Payments website. Physicians and...more

FDA Gives Guidance on Compounding for Human Use

In July 2014, the U.S. Food and Drug Administration (FDA) released five documents containing policies and proposals that affect both traditional compounding pharmacies and outsourcing facilities that compound drugs for human...more

Health Alert (Australia) - July 14, 2014

In This Issue: Judgments; Legislation; and Reports. Excerpt from Judgments: Commonwealth - 4 July 2014 - Angelos v Minister for Health [2014] FCA 706 - This was an application made to the...more

Antimicrobial Resistance Poses ‘Apocalyptic’ Scenario

Antibiotics have hit the black market, and the hot-commodity counterfeits don’t bode well for the health of those who take them. The pills whose purpose is to fight infection have become so ubiquitous that germs are...more

DEA Schedules Tramadol As A Schedule IV Controlled Substance

On July 2, 2014, the Drug Enforcement Administration (DEA) published its Final Rule placing tramadol into Schedule IV of the Controlled Substances Act (CSA). Tramadol is a synthetic opioid analgesic used in the...more

Business News Digest – July 2014

In this issue: - SEC v. Citigroup: A New Standard for Reviewing Consent Decrees - Credit Unions Beware – the TARP Watchdog Is Ready to Pounce - Canada's New Anti-Spam Legislation: What Does It Mean for...more

FDA Issues New Drug Compounding and Outsourcing Facility Guidance - The New Policy Documents Clarify FDA's Expectations and...

The FDA issued multiple policy documents on July 1, 2014, to implement the Compounding Quality Act (CQA). Congress enacted the CQA in November 2013 as part of the Drug Quality and Security Act (DQSA), in response to the...more

CMS Proposes Changes to Sunshine Act Reporting

Drug and device manufacturers breathing a sigh of relief after completing their 2013 data submissions under the Physician Payment Sunshine Act (the “Sunshine Act’) must now contend with four proposed changes to the Sunshine...more

Health Care Update - July 2014

In This Issue: - E&C continues to push for bipartisan efforts to improve drug pipeline - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other Health Care...more

An Unsuccessful Reach for the STELARA, Written description of generic biomolecule claims

AbbVie owns US 6,914,128 (’128), which covers a variety of anti-IL12 monoclonal antibodies. AbbVie markets an anti-IL12 monoclonal (viz. Humira®) as a treatment for a variety of auto-immune disorders, including psoriasis....more

FDA Releases Compounding Policy Documents

The U.S. Food and Drug Administration (FDA) has released five policy documents regarding compounded human drug products in connection with its continued implementation of the compounding provisions of the Drug Quality and...more

459 Results
|
View per page
Page: of 19