FDA Reaffirms Commitment to Personalized Medicine

30 October 2013 Personalized Medicine Bulletin Blog

In a report released on October 29, 2013, the U.S. Food and Drug Administration (FDA) announced its continued commitment to advancing personalized medicine. “Paving the Way for Personalized Medicine: FDA’s Role in a New Era of Medical Product Development” (“Report”) outlines the FDA’s unique role and responsibilities that it has in helping usher in medical products and technologies that are key to personalized medicine. The Report also outlined the FDA’s ongoing work with health care professionals, researchers, medical device and drug manufacturers to bring safe and effective personalized treatments to the public. The Report is a comprehensive overview of the rapid growth of personalized medicine and its unique challenges.

The FDA’s View of, and Commitment to, Personalized Medicine

Personalized medicine is often defined as the tailoring of medical treatment to the individual characteristics, needs, and preferences of an individual patient during all stages of care, including prevention, diagnosis, treatment, and follow-up. The Report noted that personalized medicine is not limited to pharmaceutical therapy, but also  includes advances in computational power, medical imaging, mobile medicine and regenerative medicine.

In addition to reviewing the internal structural and administrative changes that the FDA recently implemented to advance personalized medicine, the Report noted that the following significant challenges remain:

  • limited understanding of the intrinsic biology of disease;
  • common conditions involving multiple genes/biomarkers;
  • an outdated disease classification;
  • lack of agency infrastructure;
  • clinical implementation of new diagnostics;
  • investment uncertainties; and
  • limitations on access to personalized therapeutics.

The Report concludes by noting that while many of the challenges are beyond the scope of the FDA’s set of roles and responsibilities, the agency is committed to working in concert with all key stakeholders to find solutions that will help move this promising field forward. Moreover, the FDA announced its continued commitment to facilitate the development of personalized medicine by advancing the science and tools that will drive innovation and collaboration in the field while continuing to identify opportunities to streamline regulatory processes.

A copy of the Report is available here.

This blog is made available by Foley & Lardner LLP (“Foley” or “the Firm”) for informational purposes only. It is not meant to convey the Firm’s legal position on behalf of any client, nor is it intended to convey specific legal advice. Any opinions expressed in this article do not necessarily reflect the views of Foley & Lardner LLP, its partners, or its clients. Accordingly, do not act upon this information without seeking counsel from a licensed attorney. This blog is not intended to create, and receipt of it does not constitute, an attorney-client relationship. Communicating with Foley through this website by email, blog post, or otherwise, does not create an attorney-client relationship for any legal matter. Therefore, any communication or material you transmit to Foley through this blog, whether by email, blog post or any other manner, will not be treated as confidential or proprietary. The information on this blog is published “AS IS” and is not guaranteed to be complete, accurate, and or up-to-date. Foley makes no representations or warranties of any kind, express or implied, as to the operation or content of the site. Foley expressly disclaims all other guarantees, warranties, conditions and representations of any kind, either express or implied, whether arising under any statute, law, commercial use or otherwise, including implied warranties of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Foley or any of its partners, officers, employees, agents or affiliates be liable, directly or indirectly, under any theory of law (contract, tort, negligence or otherwise), to you or anyone else, for any claims, losses or damages, direct, indirect special, incidental, punitive or consequential, resulting from or occasioned by the creation, use of or reliance on this site (including information and other content) or any third party websites or the information, resources or material accessed through any such websites. In some jurisdictions, the contents of this blog may be considered Attorney Advertising. If applicable, please note that prior results do not guarantee a similar outcome. Photographs are for dramatization purposes only and may include models. Likenesses do not necessarily imply current client, partnership or employee status.

Related Services

Insights