In a highly anticipated step, which had been teased by agency leadership in their public appearances over the past several months, FDA released a series of draft guidance documents pertaining to the development and approval of gene therapy products on July 11, 2018. As a follow up to its milestone gene therapy product approvals in 2017 (see here and here), FDA had promised to develop gene therapy-specific guidelines to help spur innovation in this area by providing industry with useful advice and greater regulatory clarity. However, it’s fair to say that we were not expecting to see this large of a transparency commitment by the Agency, which concurrently issued six new guidance documents. FDA Commissioner Scott Gottlieb also issued a lengthy same-day statement on the Agency’s “efforts to advance development of gene therapies,” in which he stated in part: Continue Reading FDA Releases Series of Gene Therapy Guidance Documents: From Drug Development to Postmarket Monitoring

Last week, CMS published the Revised Draft 2018 Medicare Marketing Guidelines and requested feedback from all interested parties.

The draft includes many small changes to the Marketing Guidelines, including but not limited to those in the following areas:

  • Multi-language inserts – CMS wants to defer to the more robust requirements established by Section 1557 of the Affordable Care Act
  • Non-English Language Disclaimer – Plan Sponsors will be required to include the non-English language disclaimer on ANOC/EOC, LIS Rider, Comprehensive or Abridged Formulary, Star Ratings, Summary of Benefits, Part D Transition Letters.
  • Use of Star Ratings – The draft includes multiple changes relating to how and when a Plan Sponsor can use its Star Ratings, including that CMS will provide a Gold Star icon each fall to 5 Star Plans that the Plans can use on their marketing material.  Plans may not create their own gold star icon.
  • Unsolicited Electronic Communication – Plan Sponsors will be required to include an opt-out process for enrollees and the draft instructs Plan Sponsors that an individual “liking” the Plan’s social media page does not constitute the individual agreeing to receive communications from the Plan Sponsor outside of the social media forum.
  • Provider Affiliation Announcements – Plan Sponsors and providers will be allowed to announce new or continuing affiliations only once an agreement between the parties has been approved and the draft clarifies that such announcements that describe plan benefits, premiums, or cost sharing are marketing materials and must be submitted to HPMS, and that the Plan Sponsor is responsible for ensuring that providers comply with the MMG distribution and mailing guidance for Provider-Based Activities.
  • Review of Materials in the Marketplace – Plan Sponsors are reminded that they must report to CMS all self-identified errors in all marketing materials.
  • Third-Party Websites – This is a new section, at 100.7.  The draft requires Plan Sponsors to submit third-party marketing websites to HPMS, even if there is no benefit information included on the third-party website.  CMS recognizes that website owners may work with multiple Plan Sponsors and recommends that the Plan Sponsors coordinate the multi-plan submission.  The section also lists activities that third-party websites are prohibited from doing.

CMS explains that it is interested in comments on all sections and changes, but is particularly interested in comments regarding changes to provider-affiliation announcements and the newly added section regarding third-party websites.   Comments on the draft are due to CMS by 5:00pm (ET) Friday, February 3, 2017 and may be submitted through CMS’s survey site.

FDA released two new draft guidances on Monday, August 8 in an attempt to help device manufacturers determine when a modification triggers the obligation to file a new 510(k) under 21 C.F.R. § 807.81(a)(3). The first draft guidance, entitled Deciding When to Submit a 510(k) for a Change to an Existing Device (“2016 Device Change Guidance”), is a revision to FDA’s 1997 final guidance of the same name (“1997 Final Guidance”).  The other is a spinoff guidance, entitled Deciding When to Submit a 510(k) for a Software Change to an Existing Device (“2016 Software Device Change Guidance”), which is specific to software modifications.  It is important to note that the 1997 Final Guidance represents FDA’s official current policy on regulatory responsibilities stemming from device modifications, but in our experience, elements of the policy in the draft guidances may be used by the FDA immediately even before finalization. Continue Reading FDA Releases Revised Guidance on Device Modification Policy

On May 10, 2016, FDA released its first draft guidance for medical device manufacturers who are using additive manufacturing (AM), commonly referred to as 3D printing. The draft guidance, entitled “Technical Considerations for Additive Manufactured Devices,” was informed by a public workshop on 3D printed devices that FDA hosted back in October 2014, as well as the Agency’s experience with several dozen 3D printed devices that have already gone through its premarket review process.

In the broadest sense, AM is a process that uses computers to build complex three-dimensional objects by successively depositing two-dimensional layers of material that are then synthesized to form the final three-dimensional object. As FDA points out, the process “allows device manufacturers to rapidly alter designs without the need for retooling and to create complex devices built as a single piece.” The AM process is particularly appealing in the medical device field, where it can be used to create anatomically-matched devices by using a patient’s own medical imaging. This type of 3D printing also allows for the creation of structures and surfaces that are either impossible or impracticable to create using traditional manufacturing approaches.

The new document represents FDA’s initial thoughts on the emerging field of AM technology as it relates to medical devices, and the Agency points out that its recommendations may change as additional information becomes available, meaning this is a so-called “leap frog” guidance. The guidance is also limited in scope: it does not address the incorporation of biological, cellular, or tissue-based products in the AM process which, as the Agency notes, may require additional regulatory and manufacturing process considerations and/or different regulatory pathways. The Agency also clarifies that point-of-care device manufacturing — that is, the manufacturing of a device in a hospital or in doctor’s offices rather than at a manufacturing facility — may raise additional technical considerations.

Specifically, the draft guidance addresses two aspects of medical devices manufactured using different AM technologies: (1) designing and manufacturing the devices, and (2) testing the devices. Continue Reading FDA Releases Draft Guidance for 3D Printed Medical Devices

Written By: Ryan J. Cuthbertson

The Office for Human Research Protections (OHRP) is extending the comment period for its Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care (Draft Guidance).  Parties interested in commenting will now have an additional 30 days – until January 23, 2015.  As noted previously, the Draft Guidance “aims to clarify many of the issues…about the use of standard-of-care procedures in clinical research” and was initially published on October 24, 2014.  Below is a look at some of the comments received thus far. 

OHRP is extending the deadline in response to public requests to allow interested parties sufficient time to fully review and thoughtfully respond to the document.  An extension was called for by organizations such as Public Responsibility in Medicine and Research (PRIM&R) and Rare Disease Legislative Advocates (RDLA), the latter of which solicited petitions to aid the request, citing the dramatic impact of the guidance on rare disease patients and families. 

Continue Reading Office for Human Research Protections Extends Comment Period for Draft Guidance