Skip to content

Menu

ChannelsPublishersSubscribe
LexBlog, Inc. logo
LexBlog, Inc. logo
ProductsSub-MenuBlogsPortalsTwentySyndicationMicrositesResource Center
Join
Search
Close
Join the Movement. Blog 4 Good

FDA Issues New Guidance Documents on Regenerative Medicine but Delays Enforcement

By David Horowitz, Mike Druckman, Jim Johnson & Lowell Zeta
November 17, 2017
EmailTweetLikeLinkedIn

Yesterday, the U.S. Food and Drug Administration (FDA) announced a comprehensive framework for development and oversight of regenerative medicine products, including innovative cell-based therapies.  This initiative builds on the agency’s existing framework to set forth more clearly which products are subject to regulatory enforcement. In September, as we previously discussed here and here, FDA’s Commissioner, Dr. Scott Gottlieb, prescribed a commitment for stepped-up enforcement against unscrupulous companies taking advantage of vulnerable patients.  In yesterday’s press release, Dr. Gottlieb reaffirmed this commitment, and also stated that the agency supports the innovation being pursued by “responsible product developers” who represent the vast majority in the field.  He emphasized the goal of providing greater clarity to facilitate understanding as to where the regulatory lines are drawn.  FDA’s announcement included four guidance documents, two draft and two final, which defined a risk-based framework to drive advances in regenerative medicine and set forth how the agency intends to focus its enforcement actions against products that raise potentially significant safety concerns.

Despite the FDA’s strong language establishing this framework, the agency also stated in the final guidance relating to “minimal manipulation” and “homologous use” that the agency intends to exercise enforcement discretion, applicable to products intended for autologous use, for violations of 21 CFR 1271, for a 3-year period, except for products that pose a potential significant safety concern.  The apparent justification for the enforcement discretion is to provide time for product developers to obtain FDA approval.  Unlike the agency’s September announcement on stem cell clinics, this one was not packaged with any new enforcement action announcements.  We will be closely watching as FDA continues to implement the revised framework and will keep you posted should FDA determine that there are potential significant safety concerns that warrant enforcement.

 

 

Photo of David Horowitz David Horowitz

Partner, Washington, D.C.

David Horowitz brings 25 years of combined experience at the U.S. Department of Health and Human Services (HHS) and the FDA to help clients anticipate and navigate regulatory challenges, and participating in the policy-making process.

As Deputy General Counsel at…

Partner, Washington, D.C.

David Horowitz brings 25 years of combined experience at the U.S. Department of Health and Human Services (HHS) and the FDA to help clients anticipate and navigate regulatory challenges, and participating in the policy-making process.

As Deputy General Counsel at HHS (2010-2017), David oversaw and coordinated legal services in support of FDA, the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and international and emergency preparedness programs. His work focused on FDA regulatory policy and litigation. During his tenure at FDA – which included five years as head of the Office of Compliance for drugs, and three years as Assistant Commissioner for Compliance Policy – David played a leadership role in major initiatives, including the modernization of FDA’s approach to pharmaceutical manufacturing quality and the agency’s efforts to develop and implement a more scientific, risk-based approach to inspection and enforcement.

Over the course of his career at HHS and FDA, David developed substantial knowledge pertaining to FDA law and policy, with particular emphasis on pharmaceuticals, compliance, and the application of administrative law. He also developed a deep understanding of the institutions, organizational structures, procedures, and cultures through which regulatory policy and compliance decisions are considered, developed, and implemented across all branches of government, including Congress and the courts, as well as various components of FDA, HHS, Office of Management and Budget, Department of Justice, and the White House.

Read more about David HorowitzEmail
Show more Show less
  • Posted in:
    Administrative
  • Blog:
    Focus on Regulation
  • Organization:
    Hogan Lovells
  • Article: View Original Source

Stay Connected

Facebook LinkedIn Twitter RSS
Real Lawyers

Company

  • About LexBlog
  • Careers
  • Press
  • Contact LexBlog
  • Privacy Policy
  • Editorial Policy
  • Disclaimer
  • Terms of Service
  • RSS Terms of Service

Products

  • Products
  • Blogs
  • Portals
  • Twenty
  • Syndication
  • Microsites

Support

  • 1-800-913-0988
  • Submit a Request
  • Support Center
  • System Status
  • Resource Center

New to the Network

  • The HB Blog
  • The Tax Trotter
  • The Westchester Litigator
  • Data Privacy + Cybersecurity Insider
  • Law from the East to the West
Copyright © 2021, LexBlog, Inc. All Rights Reserved.
Powered By LexBlog