FDA Advances LDT Dialogue with New Discussion Paper Containing Updated CMS/FDA Oversight Proposal

On January 13, 2017, the Food and Drug Administration (FDA) released a discussion paper concerning an updated proposed framework for oversight of laboratory developed tests (LDTs).  According to FDA, the updated proposal is the result of ongoing engagement with industry stakeholders.   Under the proposal, the FDA generally stands by its position that a complementary risk-based oversight framework that involves both the FDA and the CMS Clinical Laboratory Improvements Amendments (CLIA) program is the preferable alternative to a CMS-only framework.  However, the updated proposal generally scales back FDA’s involvement in the framework and emphasizes the need for regulatory flexibility.

FDA’s new discussion paper does not represent the formal position of FDA, nor is it enforceable.  The paper is meant merely to “advance the public discussion” by providing “a possible approach to spur further dialogue.”

Do not let this disclaimer (or the upcoming change in White House administration) dissuade you from reading the new paper.  Change is coming for LDTs and diagnostics generally, regardless of who is in the White House.  If your business relates in any way to LDTs and diagnostic tests currently regulated by FDA, then we suggest taking the time to read FDA’s updated proposed oversight framework and considering how this could impact your business operations and projections over the next decade and beyond.

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Join Us: Free CLE Webinar on Best & Worst Drug/Medical Device Decisions of 2016

Reed Smith’s Life Sciences Health Industry Group will be hosting an upcoming CLE webinar, “The Good, the Bad and the Ugly: The Best and Worst Drug/Medical Device Decisions of 2016” on Wednesday, January 18, 2017 at 12 p.m. ET.

Each year since 2007, James Beck, Reed Smith’s Senior Life Sciences Policy Analyst and the founder of the popular Drug and Device Law blog, has compiled and posted lists of the 10 best and 10 worst drug and medical device court decisions for that year, with the input of his fellow Drug and Device Law bloggers. These cases are selected based on their likely precedential value, their importance to drug and device manufacturers, and their inherent (and subjective) merit.

In this webinar, James – along with Reed Smith partners and fellow Drug and Device Law bloggers Eric Alexander and Steven Boranian — will explain the significance, whether good or bad, of each case and provide insight into how the cases will likely be influential in the future.

This program is free and presumptively approved for 1.5 general CLE credit in California, Illinois, New Jersey, Pennsylvania, Texas and West Virginia. For lawyers licensed in New York, this course is eligible for 1.5 credit under New York’s Approved Jurisdiction Policy.

You can register by clicking here.

Radiopharmacies Celebrate the New Year with Long-Awaited FDA Guidance

On December 29, 2016, the U.S. Food and Drug Administration (“FDA”) surprised many in the radiopharmacy industry by issuing a long-awaited draft guidance entitled “Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies.”  The guidance addresses conditions under which the FDA does not intend to take action for violations of 505, 502(f)(1) and 501(a)(2)(B) of the Food, Drug and Cosmetic Act (“FD&C Act”) when a 503A state-licensed nuclear pharmacy that is not a 503B outsourcing facility compounds or repackages radiopharmaceuticals for human use.  Although the guidance will need some tweaking and it fails to acknowledge ongoing distribution problems in the radiopharmacy supply chain, it is a very welcome development given that the most recent official Agency guidance on this topic was issued in 1984.

Yes – 1984.  For this reason alone, please join us and many others across the country as we ring in the New Year with a toast to FDA.  Cheers!

As a threshold issue, the guidance acknowledges that although radiopharmaceuticals are generally not eligible for the 503A exemptions, there are certain circumstances under which the FDA will not take action for violations of the FD&C Act.  Specifically, the guidance sets forth two major categories of these circumstances: (1) “minor deviations” and repackaging; and (2) compounding other than minor deviations.

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Key Provisions of 21st Century Cures Act – Interest to Drug/Device Clients

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Cures Act). It is hoped that provisions in the new bill, and the $6.3 billion it provides for medical research over the next decade, will spur innovation and new progress in medical treatments for the patients who need them.

This Client Briefing summarizes and analyzes the provisions in the Cures Act related to drug, device, and biologic development and approval. A companion Client Briefing focuses on provisions of the Cures Act that have not received as much attention but are equally significant, those affecting the Medicare and Medicaid programs. In addition, our recent blog post addresses the Cures Act provisions regarding mental health and substance abuse, and funding for combating opioid abuse.

To read more about the major drug, device, and biologic development and approval provisions contained in the Cures Act, read our full Client Briefing here.

FDA Consumer Update: The 3Rs of 3D Printing – FDA’s Role

On December 21, 2016, the U.S. Food and Drug Administration (“FDA”) posted a Consumer Update and accompanying video on the “The 3Rs of 3D Printing: FDA’s Role,”  which reconfirms its position on the importance of 3D printed medical devices.  The FDA sums up its role in this “innovative space” as regulate, research, and resource (i.e., the “3Rs”).  In particular, the video posted by FDA, which is narrated by LT James Coburn, a senior research engineer at FDA, describes how scientists at the FDA are currently using 3D printers, as well as  examples of 3D printed devices, including anatomical models and cranial replacement plates.  FDA states that 3D printing devices undergo the same “high quality review that devices made through other methods go through.”  FDA discusses its work with universities and the 3D printing industry to understand the technology, materials, and 3D printer itself, so it can evaluate safety and effectiveness of 3D printed devices.  While the FDA mentions 3D bio-printing, it states that it is a long way off, but FDA is closely working with universities and others in the industry to foster innovation.  Although the update and video are succinct, they help show that 3D printing is still on the FDA’s agenda and the agency is continuing to better understand this technology and its place in improving healthcare.

To learn more about the 3D printing of manufactured goods and medical devices, read our recent Reed Smith second edition 3D printing white paper: 3D Printing of Manufactured Goods: An Updated Analysis, as well as our first edition 3D printing white paper: 3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles.

Reed Smith Launches Second Edition of 3D Printing White Paper

Following up the success of its first, medical device-focused 3D printing white paper, 3D Printing of Medical Devices:  When a Novel Technology Meets Traditional Legal Principles, Reed Smith’s 3D Printing Task Force has now launched a second edition of its 3D printing publication white paper addressing 3D printed products more broadly:  3D Printing of Manufactured Goods: An Updated Analysis.  This new edition complements and expands on the issues raised by the first edition, and examines the legal ramifications and risks associated with all aspects of 3D printing and the different products that this novel technology is capable of creating.  While the technology is still in its infancy and the law is untested in many respects, understanding the legal issues is the first step to avoiding potential pitfalls for anyone associated with 3D printing, from designers, to manufactures, to sellers, to consumers.

The white paper chapters address a wide range of developing legal, safety and security issues, including:

  •  Constitutional Issues (regarding 3D printed guns)
  •  Commercial Litigation
  •  Product Liability
  •  3D Printing/Component Parts/Raw Materials
  •  Insurance Issues
  • Intellectual Property Issues
  • Data Privacy
  •  Environmental Safety

The first and second editions of these white papers are meant to be a comprehensive, up-to-date resource on the legal issues involved in 3D printing.  As the law and technology develops, new and updated chapters will be released, with the prior editions serving as building blocks.

To read the new 3D printing white paper, click here.

MDR Reporting Final Guidance

FDA issued a final guidance on November 8, 2016, “Medical Device Reporting for Manufacturers”.  As with all such guidance documents, it is nonbinding:  “It does not establish any rights for any person and is not binding on FDA or the public.”  Nevertheless, for those interested in medical device reporting, the document is required reading as it collects and refines Agency positions and expectations on everything from adverse event reporting basics, to definitions, to procedures and timing.

One item of potential utility to device manufacturers involved in product liability litigation is this Q & A:

3.4 When I submit an MDR report, is the report considered an admission that my device caused or contributed to the reported event?

No, the submission of a report or related information to us and our release of that information is not necessarily an admission that you, your employees, or your device caused or contributed to the reportable event [21 CFR 803.16].  We have included such a disclaimer on FDAs [sic] public database, [MAUDE] – Manufacturer and User Facility Device Experience.

This notion — that submission of an MDR is not an admission that the device actually caused the reported adverse event — is not new, but it is good to see it restated in this Final Guidance nonetheless.


CMS Finalizes Two-Track System to Implement Significant Changes in Medicare Physician Payment Policies Under MACRA

The Centers for Medicare & Medicaid Services (CMS) has finalized sweeping reforms of the Medicare physician fee schedule (MPFS) update framework, as mandated by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). Beginning in 2017, physicians can choose one of two tracks within its “Quality Payment Program” to determine their MPFS update: reporting under the Merit-based Incentive Payment System (MIPS) or participation in an Advanced Alternative Payment Model (APM). A physician’s 2019 MPFS payment update (positive or negative) is based on action in 2017 – leaving little time to digest and prepare for the new framework before the system kicks in January 1, 2017. In order to give physicians and other affected clinicians additional flexibility going into 2017, CMS adopted several “transition” policies that will allow physicians to “pick their pace of participation” and report fewer quality measures, or report for a partial year and still avoid a negative payment adjustment in 2019, and possibly qualify for a positive adjustment.

While CMS transition policies are intended to help physicians avoid payment cuts in the first year of the program, these policies add to the complexity of the regulations. Read more about the major provisions of the final rule’s new payment framework and significant changes from the proposed rule in our Reed Smith Client Alert here.


Significant Changes for Long-Term Care Facilities Participating in Medicare and Medicaid Programs Issued by CMS

The Centers for Medicare & Medicaid Services (CMS) issued a final rule on September 28, 2016, comprehensively updating and extensively revising the requirements for participation (ROPs) for long-term care (LTC) facilities participating in the Medicare and Medicaid programs (the Final Rule). As the first major update to the requirements for LTC facilities in 25 years, the Final Rule will have a dramatic impact on LTC facility operations and finances. The Final Rule adopts numerous changes to the existing ROPs proposed in the July 16, 2015 proposed rule, and also includes various revisions to the proposed rule, in particular, modifications to the staffing and training requirements, care planning rules, infection prevention and control program provisions, and the prohibition on facilities’ use of pre-dispute arbitration agreements.

This discussion is not new here on the blog – we previously blogged about it here, as well as on our Health Industry Washington Watch blog. CMS reports that it received nearly 10,000 public comments on the proposed rule. In response to comments regarding the cost and resources required to achieve compliance with these significant new requirements, CMS will phase-in implementation in three phases.  Phase One, which includes many of the health and safety requirements, must be implemented by the effective date of the regulations, November 28, 2016.  Phase Two and Phase Three require compliance by one year and three years, respectively, from the effective date of the Final Rule (i.e., November 28, 2017 and November 28, 2019).

For more information on CMS’ Final Rule and the changes in requirements for LTC facilities participating in Medicare and Medicaid programs, read our full Client Alert here.

Philadelphia Life Sciences CLE Day for In-House Counsel: November 10

Reed Smith’s Life Sciences Health Industry Group is hosting a Life Sciences CLE Day at our Philadelphia office on Thursday, November 10. The day starts with breakfast and networking at 8:30 a.m. and sessions commence at 9 a.m. The event, which includes a working lunch, concludes at 2:30 p.m. This program is geared toward in-house counsel; space is limited.

Sessions include:

The CLE Day is presumptively approved for 6 CLE credits in New Jersey and 5 CLE credits in Pennsylvania. An application for Delaware credit is pending. For lawyers licensed in New York, this course is eligible for 6 credits under New York’s Approved Jurisdiction Policy. We hope to see you there!

For more information, or to register, please visit our website.