News & Analysis as of

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FDA Hosts Webinar Addressing Social Media Draft Guidance

The Food and Drug Administration hosted a Social Media Draft Guidance Webinar.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

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

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

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

Federal Circuit Looks for a Different Kind of Unexpected Results in BMS v. Teva

In Bristol-Myers Squibb Co. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit affirmed the district court’s finding that BMS’s Baraclude® patent is invalid as obvious. In so doing, the court gave little weight to...more

Drug Compounding: Manufacturing Standards Announced for Outsourcing Facilities

In late 2013, Congress passed the Drug Quality and Security Act (DQSA) in response to a deadly fungal meningitis outbreak linked to a sterile compounded injectable drug shipped across the country and responsible for more than...more

Drug Distributor and Pharmacies Obtain Partial Dismissal of State and Federal FCA Claims

On June 10, 2014, a New York federal court dismissed, in part, state and federal False Claims Act (FCA) claims brought against Novartis Pharmaceuticals Corporation and pharmacies to which it distributed (CVS Caremark Corp.,...more

FDA Offers Guidance for Choosing Prescription Drug Names

If you've seen your share of prescription drug commercials, you've likely marveled at the odd drug names: Moexipril. Oxcarbazepine. Zafirlukast. You might think pharmaceutical companies just prefer complex, new combinations...more

HHS to Continue Enforcing Orphan Drug Exclusion from 340B Program

The Department of Health and Human Services (HHS) through its Office of Health Resources and Services Administration (HRSA) announced last week that, although a court recently struck down its regulation addressing application...more

Coveting Characters: Navigating FDA's Draft Guidance on Social Media

Last week the U.S. Food and Drug Administration (FDA) issued two long-awaited draft guidances on social media: Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and...more

Making Use of Social Media: FDA Releases Two Draft Guidelines on the Use of Social Media Platforms by Drug and Device...

The Food and Drug Administration (FDA) has released two long-awaited draft guidance documents for the drug and device industries revolving around the use of social media platforms by drug and device manufacturers —...more

FDA Issues Draft Guidance for Drug and Device Information on Social Media

On June 17, 2014, the FDA issued two draft guidance documents relating to the use of social media and the Internet to promote prescription drugs and medical devices. The FDA described how a company should use a character...more

Massachusetts Enacts New Biosimilars Substitution Law

On June 23, 2014, Governor Deval Patrick signed into law House Bill 3734, “An Act Relative to the Substitution of Interchangeable Biosimilars” (now Chapter 143 of the Acts of 2014). The new Act authorizes pharmacists to...more

New Obamacare Benefit Mandate Takes Aim at Breast Cancer

Under the Affordable Care Act, insurers and employers that sponsor non-grandfathered medical plans must cover and pay the full cost of specified preventive services in accordance with recommendations issued by the U.S....more

340B Registration Changes: Re-enrollment of Currently Participating Facilities and Eligibility Based on Amended Cost Reports

In April 2013, the federal Office of Pharmacy Affairs (OPA) released guidance instructing hospitals participating in the 340B Drug Pricing Program (340B Program) to register new outpatient facilities by service, rather than...more

FDA Issues Draft Guidance Docs On How To Provide Accurate Risk/Benefit Info in 140 Characters Or Less And Clean Up 3rd Party UGC...

Last Tuesday, the FDA issued two draft industry guidance documents advising pharmaceutical companies on how to accurately communicate information concerning prescription drugs and medical devices on social media and other...more

FDA Issues Two Draft Guidance Documents Relating to Internet and Social Media Use by Drug and Device Manufacturers

On June 17, 2014, the Food and Drug Administration (“FDA”) released two draft guidance documents related to manufacturer communications on the Internet and social media platforms. The two documents are (1) “Internet/Social...more

GlaxoSmithKline Fined Again – The Cost of Doing Business?

It is seen as the cost of doing business. It may be illegal, but is also highly profitable, so why stop? That seems to be the attitude of many pharmaceutical companies – and the latest proof of that comes in the form...more

Dems Call for Hearing on Costs of Hep C Drug Sovaldi

Dialing up the issue of high-cost medications, Rep. Henry Waxman, the lead Democrat on the House Energy & Commerce Committee and Rep. Diana DeGette of Colorado are calling today for a hearing into the impact Sovaldi will have...more

POM Wonderful™ News for Prescription Drug and Device Manufacturers?

Last week, the Supreme Court decided that POM Wonderful™, maker of pomegranate juice, could sue Coca-Cola Company, maker of a blended juice product that included pomegranate and blueberry juices, under the Lanham Act for...more

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