Personalized Medicine Bulletin The source for business, legal, and regulatory developments shaping an evolving industry

Category Archives: FDA

Medical Device Industry Responds to FDA’s Overseas Clinical Trial Proposed Rule

Posted by Antoinette Konski on Posted in FDA; Personalized Medicine; Uncategorized

Guest Post By Jennifer M. Forde, Nathan A. Beaver and David L. Rosen

In a resounding manner, members of the medical device industry recently filed comments reacting to the Food and Drug Administration’s proposed rule to strengthen its oversight of overseas clinical studies of medical devices. The proposed rule would replace the current practice, which does not require review by an independent ethics committee. Currently, FDA accepts data from clinical trials conducted outside the U.S. if the data are valid and the studies are conducted in conformance with the 1983 Declaration of Helsinki or the laws and regulations of the country in which the research is conducted, whichever accords greater protection to human subjects. Continue reading this entry

FDA’s Plan to Regulate LDTs

Posted by Antoinette Konski on Posted in Diagnostic Methods; FDA; FDA Guidelines; Personalized Medicine; Uncategorized

Guest Post By David L. Rosen, Nathan A. Beaver and Jennifer M. Forde  

In a remarkable move, the Food and Drug Administration recently indicated that it plans to take new steps to regulate laboratory-developed tests (“LDTs”). FDA Commissioner Margaret Hamburg made the significant announcement during a speech on June 2, 2013, at an annual meeting of the American Society of Clinical Oncology. Historically, FDA has exercised enforcement discretion when regulating LDTs and generally exempted them from regulatory requirements because LDTs have often consisted of low-risk diagnostics or tests for rare diseases with a physician evaluating the test results in the laboratory. Consequently, LDTs oftentimes have been marketed without premarket review by FDA.

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Business Models for Personalized Medicine

Posted by Antoinette Konski on Posted in Economics of Innovation; FDA; FDA Guidelines; Genetic Testing; Personalized Medicine; Reimbursement

Personalized medicine is moving from concept to reality, fueled in part by advances in sequencing technology and data analysis. However, significant business challenges remain that hinder growth and adoption of personalized health care. One such challenge how to is pay for the research and development of new diagnostics and therapies when the target patient population does not fit the traditional pharma “block buster” model. Thus, the health care industry is searching for viable business models to fund personalized therapies and companion diagnostics. How does one attract investment? How does one navigate the regulatory pathway? Will payors reimburse the diagnostic? How does one price the product and service?

The Personalized Medicine Business Summit will tackle these issues on May 14th, in San Francisco. Industry heavyweights such as Steve Burrill, Dr. Elizabeth Mansfield of FDA and Ronnie Andrews of Life Technologies will share their experience and insights on evolving business models for personalized medicine.  Further information is provided at www.personalizedmedicinesummit.com.

FDA Regulation of Laboratory Developed Tests: Benefit or Unnecessary Burden?

Posted by Antoinette Konski on Posted in Companion Diagnostics; Diagnostic Methods; FDA; Personalized Medicine; Uncategorized

The U.S. Department of Food and Drug Administration (“FDA”) has previously announced an interest in regulating diagnostic tests used in providing personalized medicine clinical care. Interested stakeholders such as the American Clinical Laboratory Association, the College of American Pathologists, and the Association for Molecular Pathology, have weighed in on whether the FDA can and should expand its jurisdiction to laboratory developed tests (“LDTs) performed by clinical laboratories. Continue reading this entry

FDA To Issue Final Guidance For In Vitro Companion Diagnostics in Mid-2012

Posted by Antoinette Konski on Posted in Companion Diagnostics; FDA; FDA Guidelines

Elizabeth Mansfield, Ph.D., Director of Personalized Medicine, Office of In Vitro Diagnostics, Center for Devices and Radiological Health of the Food and Drug Administration (FDA) announced today at the 2012 Personalized Medicine World Conference that the FDA is targeting the second quarter of 2012 to release the FDA’s Final Guidance for In Vitro Companion Diagnostic Devices. The FDA issued its Draft Guidance for In Vitro Diagnostic Devices on July 14th, 2011.  A summary of the FDA’s Draft Guidance is provided in our July 17th, 2011 post.  Thirty-three comments on the Draft Guidance were received in response to the FDA’s invitation for comments and suggestions. All public comments are available for viewing at www.regulations.gov, docket ID: FDA 2011-D-0215. The commentators represented pharmaceutical companies, diagnostic companies, trade organizations, interested individuals and patient advocacy groups.  

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Making The Case for Personalized Medicine

Posted by Antoinette Konski on Posted in Biomarkers; Companion Diagnostics; Diagnostic Methods; FDA; Health Care IT

The Personalized Medicine Coalition recently published the third edition of its state of the industry report, The Case for Personalized Medicine (“Report”). While the Coalition acknowledges greater adoption of the principles of personalized medicine by the health care industry and the public; technical, legal, regulatory and payor issues are highlighted for improvement to recognize the industry’s full potential and benefits. This post summarizes the Coalition’s view of the state of the industry and the issues identified as critical to the ongoing development and adoption of personalized medicine.

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FDA Reports on Initiatives to Drive Biomedical Innovation

Posted by Antoinette Konski on Posted in Companion Diagnostics; FDA

Today, the FDA issued a report, Driving Biomedical Innovation: Initiatives to Improve Products for Patients (“Report”) which outlines proactive initiatives to promote science and innovation to meet today’s and the future’s health care challenges. The Report notes that because of its role as both a regulator and a public health agency facilitating the development of new and innovative products, the FDA has a unique perspective on the health of the biomedical industry. The Report acknowledges that while the quality of the submissions for new health care products has increased in the last few years, the number of new innovative products has decreased. Last year the FDA received the lowest number of applications for novel drugs in nearly two decades.

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The Genomics and Personalized Medicine Act: A Look Ahead

Posted by Antoinette Konski on Posted in Companion Diagnostics; FDA; Genetic Testing; Genomics and Personalized Medicine Act; Reimbursement

Institutional barriers (e.g., limitations on product reimbursement, unclear regulatory requirements and occasional government redundancies) have been faulted for relatively slow progress toward wide spread implementation of personalized medicine. In an effort to improve access to and appropriate utilization of valid, reliable genetic tests and to secure the promise of personalized medicine for all Americans, then-Sen. Barack Obama, D-Ill., introduced the Genomics and Personalized Medicine Act in 2006 during the 109th Congress. Most recently, Reps. Patrick J. Kennedy, D-R.I., and Anna Eshoo, D-Calif., introduced H.R. 5440, the 2010 version of the bill.

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FDA Releases Guidance Document Regarding Qualification of Genomic Biomarkers

Posted by Antoinette Konski on Posted in Biomarkers; FDA; FDA Guidelines

On August 10, 2011, the Food and Drug Administration (FDA) released a guidance document describing recommendations regarding context, structure and format of regulatory submissions for qualification of genomic biomarkers. The guidance document was developed within the Efficacy Working Group of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance is provided to facilitate a consistent format for the submission of data to the end of easy review and exchange of assessments.

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CDC Issues Requests for Comments to Assess and Implement Public Health Genomics

Posted by Antoinette Konski on Posted in Companion Diagnostics; FDA; Genomics and Personalized Medicine Act

The Centers for Disease Control and Prevention (“CDC”), located within the federal Department of Health and Human Services (“HHS”) is seeking public comments, data or other information to assess the current research, policy and practice environment in public health genomics. 2011-16422.pdf  The information is solicited to assist the Office of Public Health Genomics (“OPHG”) of the CDC with its strategic plan to integrate genomics into public health research, policy, and programs with the goal of improving the health and well being of the public.  Electronic or written comments must be received on or before August 1, 2011.

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FDA “Draft Guidance” for Companion Diagnostic Devices

Posted by Jackie Wright Bonilla on Posted in Companion Diagnostics; Diagnostic Methods; FDA; FDA Guidelines

On July 14, 2011, the FDA issued “Draft Guidance” relating to regulatory approval of in vitro companion diagnostic devices/tests, also called “IVD companion diagnostic devices.” The FDA intends the Guidance to assist those (1) who develop a therapeutic product that depends on the use of such a device/test for the product’s safe and effective use, and (2) who develop a companion diagnostic device intended for use with a corresponding therapeutic product.  The FDA invites comments and suggestions regarding the Draft Guidance within 60 days. 

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PhRMA CEO Speaks at PMC’s Annual State of Personalized Medicine Luncheon

Posted by Jackie Wright Bonilla on Posted in Biomarkers; Companion Diagnostics; FDA; Reimbursement

On June 9, 2011, the Personalized Medicine Coalition (PMC) hosted its Seventh Annual State of Personalized Medicine Luncheon in Washington, D.C.  As stated on its website, PMC’s mission “is to build the foundation that underpins the advancement of personalized medicine as a viable solution to the challenges of efficacy, safety and cost.”  This year’s luncheon featured John J. Castellani, President and CEO of Pharmaceutical Research and Manufacturers of America (PhRMA) as its keynote speaker.

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Personalized Medicine – Promise, Regulation and Challenges

Posted by Antoinette Konski on Posted in Biomarkers; Companion Diagnostics; FDA; Gene Patents; Genomics and Personalized Medicine Act; Health Care IT; Reimbursement

Personalized Medicine seeks to individualize health care by identifying the most effective or most comfortable treatment for that individual.  Finding the right treatment for the right individual at the right time can be applied preventively or therapeutically to treat disease.  In one aspect of personalized medicine, an individual’s genetic code is analyzed and used to identify the individual’s disease risk so that a healthcare strategy can be implemented that focuses on prevention or early intervention rather than a reaction to an advanced stage of disease.

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