Yesterday, the Department of Justice launched 10 regional task forces aimed at identifying fraud at nursing homes that provide inferior care to elderly residents. Referred to as the Elder Justice Task Forces, the DOJ plans to launch the 10 regional task forces in the following districts across the country:
FDA announces approval of investigational blood screening test for Zika virus
On March 30, 2016, the US Food and Drug Administration (FDA) announced that an investigational blood screening test is available to screen blood donations for Zika virus. The FDA clarified that the investigational blood screening test may be used under an Investigational New Drug Application (IND). The IND process enables sponsors of investigational drugs to obtain an exemption to the federal regulatory requirement that prohibits the transport of unapproved drugs across state borders.
Supreme Court approves statistical sampling in class action
Last week, in a 6-2 decision, the U.S. Supreme Court approved the district court’s consideration of statistical sampling evidence to certify an overtime class action brought under the Fair Labor Standards Act (FLSA) in Tyson Foods, Inc. v. Bouaphakeo.
FDA issues draft guidance for approval of generic equivalents of opioid drugs with abuse-deterrent properties
On March 24, 2016, the US Food and Drug Administration (FDA) published draft guidance to assist applicants who intend to file abbreviated new drug applications (ANDAs) for approval of generic versions of opioid drug products with abuse-deterrent properties. The FDA’s
FDA requires new “black-box” safety warnings for opioid drugs
On March 22, 2016, the US Food and Drug Administration (FDA) issued a safety announcement that includes required labeling changes for immediate-release (IR) opioid pain medication (and the entire class of opioid drugs) and recommendations and information for patients and health care professionals. The FDA’s new safety warnings and required labeling changes come shortly after the Senate unanimously passed Senate Bill 483 (114th Congress) on March 17, 2016 requiring greater federal oversight of opioid prescribing practices.
D.C. Health Department issued proposed regulation establishing rules for telemedicine in the district
Late last month, the Washington D.C. Health Department issued a four-page proposed D.C. municipal regulation on the practice of telemedicine. Until now, providers in Washington D.C. have relied on a policy statement on telemedicine that was issued in November of 2014.
OCR launches Phase 2 of the HIPAA Audit Program
The HHS Office for Civil Rights (OCR) announced on Monday that it has launched the long-awaited Phase 2 of its HIPAA Privacy, Security, and Breach Notification Audit Program.
The purpose of the Audit Program is to assess the compliance of covered entities and business associates with the HIPAA Privacy, Security and Breach Notification Rules. The audits are intended to supplement OCR’s other enforcement tools, such as complaint investigations and compliance reviews.
Senate blocks anti-GMO labeling bill
On March 16, 2016, the U.S. Senate voted 48-49 against invoking cloture to cut off a filibuster on the Biotechnology Labeling Solutions Act. The bill would have established a federal standard of voluntary labeling and preempted any mandatory GMO labeling state laws. In July 2015, a similar bill called the Safe and Accurate Food Labeling Act of 2015 successfully passed through the U.S. House of Representatives.[1] In October 2015, the U.S. Senate Committee on Agriculture, Nutrition & Forestry held a hearing on the mandatory labeling of genetically engineered crops that focused on the House bill.
Company exec can face $18M in restitution for ignoring attorney warnings
On March 3rd, the Ninth Circuit ruled that the president of Commerce Planet, Inc. could be held personally liable for violations of the Federal Trade Commission Act (FTC Act) after he ignored warnings from his in-house counsel that
Senate passes critical bills for managing the Zika virus and establishing federal oversight of opioid painkillers
On March 17, 2016, the Senate passed two independent bills in response to growing concerns with the Zika virus outbreak and current opioid painkiller prescribing practices. The Senate bill addressing the Zika virus aims to fuel the development of countermeasures