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Blog: OIG Releases Advisory Opinion Regarding Laboratory and Physician Practice Agreement

On March 25, 2015, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion No. 15-04. In the opinion, the OIG addresses a laboratory’s proposal to enter into agreements...more

OIG Finds Exclusive Lab Arrangement May Violate Anti-Kickback Statute

Yesterday the Office of Inspector General for the Department of Health and Human Services (the “OIG”) issued Advisory Opinion 15-04 (“Advisory Opinion”) in which it found that an exclusive arrangement between a laboratory...more

340B Drug Pricing Program Questioned by Congressional Subcommittee

In This Issue: - Recent Developments for Multiemployer Pension Plans - Witness Statements - Questions & Answers - For More Information - Excerpt from Recent Developments for Multiemployer...more

Federal and State Agencies Announce $714 Million FX Settlement

On March 19, four federal and state agencies –DOJ, the Department of Labor (DOL), the SEC, and New York Attorney General – entered into a proposed $714 million settlement agreement against a large bank to resolve allegations...more

TTAB Decisions May Be Determinative Of Trademark Infringement Litigation

In a well-written opinion, the Supreme Court ruled this week that a final TTAB decision on likelihood of confusion regarding a particular mark can be binding in separate trademark infringement litigation. The Court reversed a...more

Increased FTC Enforcement as FDA Deregulates Low-Risk Health IT Devices

The FTC steps up enforcement of misleading software and mobile app promotional claims as FDA deregulates low-risk health IT devices. In recent weeks, the Federal Trade Commission (FTC) has taken several enforcement...more

The FCC and the Uncertain Future of Privacy Oversight for Internet Service Providers

The Federal Communications Commission’s (“FCC”) net neutrality proceeding culminated this month with the release of an Order reclassifying broadband Internet access service as a common carrier Telecommunications Service...more

Environmental Appeals Board Vacates Penalties for TSCA Section 8(e) Violations

The U.S. Environmental Appeals Board (EAB) issued an opinion this month that sheds light on section 8(e) of the Toxic Substances Control Act (TSCA); specifically, the applicability of the “continuing violations doctrine” to...more

Can the U.S. – EU Safe Harbor Weather the Storm?

On 24 March, the Court of Justice for the European Union (CJEU) heard argument on a case that could significantly impact, if not invalidate altogether, the Safe Harbor framework that facilitates the flow of personal data from...more

Restrictions Eased for Communications-Related Items Exported to Sudan

On February 18, 2015, in a coordinated action, the Commerce Department's Bureau of Industry and Security (BIS) and Treasury Department's Office of Foreign Assets Control (OFAC) announced and implemented changes to the...more

EUROPE: EU-US data flows at risk? European Court of Justice today heard Facebook case.

Yesterday, the Schrems v. Irish Data Protection Commission case was brought before the Court of Justice of the European Union (‘CJEU’) for an oral hearing, following referral by the Irish High Court. While the final ruling by...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

The Tyranny of the Judiciary

There has always been a tension between the need for a final arbiter of the law and the inherent power associated with such a role placed in the judicial branch. Jefferson himself was wary of this tendency, writing in a...more

Alert - Biologics Price Competition and Innovation Act (BPCIA) Developments

The Evolving World of Biosimilars - Amgen, Inc. v. Sandoz, Inc. Addressing two new issues in the Biologics Price Competition and Innovation Act (BPCIA), the Northern District of California issued an order, on...more

Blog: Early 2015 Federal Policy Developments Impacting Medical Technology Companies

Health care is always a major issue in Washington, DC but recently how to promote innovation in medtech has become a priority within that conversation. ...more

One More Hurdle Cleared – Amgen’s Preliminary Injunction Motion for Filgrastim is Denied

On March 19, 2015, Judge Seeborg of the United States District Court for the Northern District of California denied Amgen Inc.’s motion for a preliminary injunction in the Amgen v. Sandoz case, thereby removing one more...more

OCR’s Enforcement of HIPAA’s Privacy and Security Rules Continues with Robust 2014

With the news of the recent cyber-attack and resulting data breach at health insurance giant Anthem Inc., the buzz around data security and privacy is again high. The Anthem breach serves as a reminder to those entities...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

U.S. International Trade Commission Institutes Investigation Under 100-Day Pilot Program Examining Complainant’s Standing to File...

The U.S.I.T.C. instituted its first investigation under its 100-day pilot program for early determination of a specific potentially case-dispositive issue....more

FDA Issues Revised Draft Guidance on Disclosures of Risk Information in Consumer-Friendly Print Advertisements and Promotional...

The U.S. Food and Drug Administration (FDA) recently released its Revised Draft Guidance entitled “Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and...more

The SEC and the Pharmaceutical Industry - Recent Commentary by the SEC's Enforcement Director Identifies Areas of SEC Focus...

Recently, the United States Securities and Exchange Commission’s (“SEC”) Enforcement Director, Andrew Ceresney (“Ceresney”), spoke to pharmaceutical compliance personnel at the CBI’s Annual Pharmaceutical Compliance Congress...more

Update on State Attorneys General: Connecticut Creates a Permanent Privacy Department; NAAG Covers Big Data, Cybersecurity, and...

The federal government may be pushing a cybersecurity and data privacy agenda, but that doesn’t mean that the states are taking a back seat. The state attorneys general are maintaining their focus on issues relating to...more

California Appellate Court Agrees with Defendants on Prop. 65 Exposure Averaging

In one of the most significant appellate decisions interpreting California’s Prop. 65, the California Court of Appeal on March 17 ruled that, for purposes of establishing the Prop. 65 “safe harbor” defense, exposure to a...more

Alert: Federal Policy Developments Impacting Medical Technology Companies

Health care is always a major issue in Washington, DC but recently how to promote innovation in medtech has become a priority within that conversation. Thus far, 2015 has produced a major legislative initiative in the form of...more

NAIC Amps Up Cybersecurity Oversight

The NAIC has begun its efforts to amp up state insurance department oversight of cybersecurity practices with the release of two documents for public comment. The first, entitled Principles for Effective Cybersecurity...more

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