Health Law Advisor

On December 18, 2014, FDA released proposed regulations that would make prescribing information for drugs and biologics available online and prohibit distribution of paper copies as part of product packaging.  FDA's stated goal is to make prescribing information widely and easily accessible to healthcare providers and consumers alike, but some consumer and provider groups are criticizing the proposed rules because they may limit access to prescribing information in communities where the Internet is not readily available.  The proposed rules also go against Senate ...

Earlier today, FDA published guidance, for immediate implementation, effectively delaying the effective date of the product tracing requirements for manufacturers, wholesale distributors or repackagers until May 1, 2015.  This guidance appears to be a continuation of FDA's efforts to address industry's concerns about the implementation of the DSCSA product tracing requirements that are effective January 1, 2015.

It is unclear whether the ghosts of FDA past, present or future had anything to do with today's announcement, but this Dickens-esque change of heart should ensure ...

On December 15, 2014, the Supreme Court of the United States decided Dart Cherokee Basin Operating Co. v. Owens, a class action removal case.

In short, the Dart case is welcome news to employers. Standards for removing a case from state to federal court have been an abiding point of concern for employers faced with "home town" class actions. In more recent times, this problem has become a point of interest to employers in health care and other industries that are beset by cybersecurity and data breach cases originating in state courts but calling for the application of federal privacy ...

FDA is the subject of a lot of criticism, some deserved, and some not.  However, I don't think FDA gets enough praise when it does something right.  Therefore, I thought it was important to follow up on my previous blog and let everyone know that FDA has cleared up some of the ambiguities I mentioned there.

Specifically, on December 9th, FDA issued draft guidance making it clear that federal, and not state, law determines whether a company needs to register with FDA as a wholesale distributor or 3PL as required by the DSCSA.  This clarification likely has the greatest impact on prescription ...

Our colleague Steven Swirsky at Epstein Becker Green wrote an advisory on an NLRB ruling that affects all employers: "NLRB Holds That Employees Have the Right to Use Company Email Systems for Union Organizing - Union and Non-Union Employers Are All Affected." Following is an excerpt:

In its Purple Communications, Inc., decision, the National Labor Relations Board (“NLRB” or “Board”) has ruled that “employee use of email for statutorily protected communications on nonworking time must presumptively be permitted” by employers that provide employees with access to ...

In response to multiple requests, the Centers for Medicare and Medicaid Services ("CMS") have extended the deadline for comments on the proposed changes to the home health conditions of participation ("CoPs").  Home health providers and other interested stakeholders now have until 5:00 p.m. EST on January 7, 2015 to submit comments to CMS.

The proposed changes to the CoPs were published on October 9, 2014[1] and represent the most significant changes to the home health CoPs in seventeen years.  According to CMS, the new CoPs are intended to better reflect modern home health practice by ...

Regarding the Supreme Court’s Integrity Staffing Solutions v. Busk opinion, issued today, our colleague Michael Kun at Epstein Becker Green has posted “Supreme Court Holds That Time Spent in Security Screening Is Not Compensable Time” on one of our sister blogs, Wage & Hour Defense.

Following is an excerpt:

In order to prevent employee theft, some employers require their employees to undergo security screenings before leaving the employers’ facilities. That is particularly so with employers involved in manufacturing and retail sales, who must be concerned with ...

Our colleaguesEmily E. Bajcsi, Clifford E. Barnes, Marshall E. Jackson Jr., and Serra J. Schlanger recently published a client alert on legislative and regulatory efforts impacting the hospice and home health industries:

• President Obama signed the Improving Medicare Post-Acute Care Transformation Act of 2014 ("the IMPACT Act") into law;
• The Centers for Medicare and Medicaid ("CMS") published the Medicare Home Health Prospective Payment System final rule for calendar year 2015 ("Final Rule"); and
• CMS published proposed changes to the home health conditions of participation ...

On Wednesday, December 10, 2014 colleague Stuart M. Gerson of Epstein Becker Green's Litigation and Health Care and Life Sciences practices in the firm's Washington, DC and New York offices will join a panel discussion on "The Manay Faces of the Affordable Care Act."  Christopher Farella of Epstein Becker Green's Litigation and Labor and Employment practices in the firm's Newark office will serve as moderator.

Issues to be addressed include:

• State of play with respect to various aspects of the ACA, particularly the employer mandate, including a discussion of recent case law.
• How ...

The 2014 outbreak of the Ebola Virus Disease ("Ebola") is the largest in history and continues to affect multiple countries in West Africa. Although reports of new Ebola cases in the U.S. – potential or confirmed – have slowed down in recent weeks, the Centers for Disease Control and Prevention ("CDC") and its various domestic and international partners continue their efforts to prevent further transmission of Ebola in the U.S. as well as abroad. Earlier this week, in fact, the CDC released two new pieces of guidance regarding treatment of Ebola that will be of particular interest ...

Last week, FDA launched Drug Trials Snapshot, a pilot program intended to provide consumers with information about the sex, age, race and ethnicity of clinical participants for six drugs approved in May and June 2014.  This pilot is intended to solicit feedback on the content, format and usefulness of the information provided in advance of an expansion of the program to include all new molecular entities subject to an approved NDA beginning in 2015.

The Drug Trials Snapshot website was developed by FDA in response to the requirements in Section 907 of FDASIA that FDA: 1) report to ...