Alerts

The Health Resources and Services Administration, part of the Department of Health and Human Services, published a Final Rule on January 5, 2017 addressing how 340B covered outpatient drug “Ceiling Prices” are to be calculated under the 340B Drug Pricing Program.

In an important decision clarifying California’s rest period requirements, the California Supreme Court has held that nearly all employees subject to the state’s rest periods rules cannot be subject to on-duty or on-call rest periods.

An interesting case came out of the Federal Circuit in Amdocs (Israel) Limited v. Openet Telecom, Inc., No. 2015-1180, 2016 WL 6440387 (Fed. Cir. Nov. 1, 2016) in which the Court reversed the district court’s granting of Openet’s motion for judgment.

On December 31, 2016, at 12:01am (i.e. not January 1, 2017), the New York State Department of Labor will implement regulations increasing the salary threshold exempting employees from overtime-pay requirements for most private employers.

On December 9, 2016, the Senate Agriculture Committee filed report language for the National Bioengineered Food Disclosure Law, the legislation signed into law by President Obama in July to amend the Agricultural Marketing Act of 1946.

On December 20, 2016, the Council of the District of Columbia voted 9-4 to approve the Universal Paid Leave Amendment Act of 2016, a landmark piece of legislation that would create one of the most generous paid family and medical leave programs in the nation.

Yesterday, the Equal Employment Opportunity Commission issued a “resource document” to provide information to applicants and employees who suffer from mental health conditions.

On December 6, 2016, the Supreme Court determined in State Farm Fire & Casualty Co. v. United States ex rel. Rigsby that violation of the statutorily mandated seal requirement, 31 U.S.C. § 3730(b)(2), in a qui tam False Claims Act case does not automatically require dismissal,

On December 7, 2016, FDA published a Notice in the Federal Register announcing that its Center for Food Safety and Applied Nutrition will begin publishing data extracted from adverse event reports the Agency has received for conventional foods, dietary supplements, and cosmetics.

On appeal from a decision in the In re Energy Future Holdings Corp. bankruptcy case, the US Court of Appeals for the Third Circuit recently held that contractual make-whole premium provisions are enforceable where the obligation to repay bond debt is accelerated by a bankruptcy filing.

This decision from the Appellate Division reversed a finding that an indenture trustee did not have the relevant standing to pursue fraudulent transfer claims, among other claims.

Trump has vowed to renegotiate NAFTA and scrap the Trans-Pacific Partnership and the flagging Transatlantic Trade and Investment Partnership. But there has been virtually no discussion of how a Trump administration would address and enforce anti-dumping and countervailing duty (AD/CVD) orders.

On November 9, Arent Fox, Aronson LLC, and Morgan Stanley hosted an executive summit for exempt organizations that featured strategies for making and saving money and tips on top governance issues.

USDA’s Food Safety Inspection Service (FSIS) recently announced that meat and poultry products may use the Nutrition Facts label recently finalized by FDA earlier this year.

Last week, FDA issued a final version of Guidance for Industry, Contract Manufacturing Arrangements for Drugs: Quality Agreements.

The standard, which was sponsored by several labor unions, will require covered healthcare providers to develop workplace violence prevention plans, training programs, and recordkeeping procedures to track certain incidents of workplace violence. 

On November 21, 2016, the US Equal Employment Opportunity Commission issued its updated enforcement guidance on national origin discrimination to replace its 2002 compliance manual section on that subject.

On November 17, FDA announced that it had revised, and finalized in part, Guidance for Industry, Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments. 

In the wake of the legalization of cannabis in the state of California following last week’s election, it is important for businesses to take stock of several legal issues as opportunities within this burgeoning market continue to grow.