Health Law Advisor

FDA published the long awaited draft guidance on wellness products last Friday. The guidance is a positive step forward for industry in that it proposes that certain general wellness products will not be subject to FDA regulation.

The draft guidance clarifies that FDA does not intend to enforce its regulations against products that are "low risk" and are intended to:

1. Maintain or encourage health without reference to a disease or condition (e.g. weight, fitness, stress) or
2. Help users live well with or reduce risks of chronic conditions, where it is well accepted that a healthy ...

Our colleague Joshua A. Stein authored Epstein Becker Green’s recent issue of its Take 5 newsletter.   In this special edition, Josh focuses on the 25^th Anniversary of the ADA and recent developments and future trends under Title III of the ADA. 

1. Website Accessibility
2. Accessible Point-of-Sale Devices and Other Touchscreen Technology
3. Movie Theater Captioning & Audio (Narrative) Description
4. The Availability of Sign Language Interpreters at Health Care Facilities
5. “Drive By” Design/Construction Lawsuits

• H-1B Nonimmigrant Season Opens on April 1, 2015, for Fiscal Year 2016
• President Obama Issues Executive Order on Immigration
• States Sue to Enjoin the Executive Order
• Federal Court in the District of Columbia Allows Worker Challenge to OPT Program
• DOS Issues New J-1 Rules for 2015
• DOS Issues January 2015 Visa Bulletin 

At the January 8-9, 2015 FDA public meeting on the agency's proposal to regulate a portion of lab developed tests (LDTs), there was much debate regarding whether FDA has jurisdiction over IVDs made at clinical laboratories. Not coincidentally, on January 7, the day before the meeting, the American Clinical Laboratory Association released a white paper developed for the Association by a couple of prominent constitutional law scholars.  The paper outlined the arguments at a high level against FDA jurisdiction over lab developed tests generally. But with all due respect to the authors as well as the speakers at the FDA public meeting, the discussion to date is taking place at such a high level that I do not find it particularly helpful. Mostly the discussions merely stake out the positions held by interested parties. They don't advance the collective understanding of the issues.

In connection with the public meeting, I developed five questions which help me think through the legal issues. I'd like to share those questions, in an effort to drive the discussion to a more granular level where differences can be more effectively debated and resolved. In addition, as with any lawyer, I'm drawn to precedent, so I'd like to share how FDA has tackled similar issues before. At the end of this post, based on precedent but also my conclusion that both sides are overstating their legal positions, I offer a path forward down the middle-of-the-road.

5 Questions That Frame FDA Authority Over IVDs Made at Labs

In posing these questions, I start with the most basic and simple and then move closer and closer to the current facts. In each case, I'll also give you what I think the answer is.

Last week both CDER and CDRH released a list of guidance documents they intend to develop or finalize over the next year.  However, it is interesting to note that the approach and information provided by each FDA center diverged significantly.  CDRH provided details as to the priority of guidances they plan on developing, offered specific metrics they will use to measure success, and opened up a docket to receive stakeholder comments.  CDER also provided a list of guidances; however the process to administer comments and specificity on what guidance documents would be prioritized was ...

By Evan J. Nagler

The State of the Union Address, scheduled for January 20, 2015, will contain new initiatives related to privacy, White House officials say. The known initiatives are the introduction of a data breach reporting bill, a bill restricting the sale of student information, and a Consumer Privacy Bill of Rights.

SETTING A NATIONAL DATA BREACH REPORTING STANDARD

President Obama is planning on introducing a data breach bill that would standardize the reporting period nationwide at 30 days. The proposed Personal Data Notification and Protection Act would require ...

On January 7, 2015, U.S. Senators Susan Collins (R-ME) and Joe Donnelly (D–IN) along with Lisa Murkowski (R-AK) and Joe Manchin (D-WV) introduced the Forty Hours is Full Time Act, legislation that would amend the definition of a “full-time employee” under the Affordable Care Act to an employee ...

On January 5, 2015, less than one month after the National Labor Relations Board (NLRB) voted to adopt a Final Rule to amend its rules and procedures for representation elections, a lawsuit has been filed in the US District Court for the District of Columbia, asserting that the Board exceeded its authority under the National Labor Relations Act (Act) when it amended its rules for votes on union representation and that the new rule in unconstitutional and violates the First and Fifth Amendments of the US Constitution.

The suit was filed by the Chamber of Commerce of the United ...

As we move into 2015, stories about the use of 3-D printing (also called additive manufacturing) in the health care industry continue to hit headlines. Some 3-D printed products are already available to U.S. patients, including knee and cranial implants, while others, including a graft device to treat aneurysms, are coming down the pipeline.

In touch with this trend, FDA has formed an Additive Manufacturing Working Group, and in October 2014, the Agency engaged industry stakeholders to discuss technical considerations surrounding 3-D printed products. However, according to ...