Health Law Advisor

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 ...

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 ...