Navigation Links
Coalition for 21st Century Medicine Issues Statement in Opposition of Genentech Petition to Restrict Lab Use of Diagnostic Tests for Physicians and Patients
Date:12/30/2008

WASHINGTON, Dec. 30 /PRNewswire-USNewswire/ -- The Coalition for 21st Century Medicine strongly opposes the citizen petition filed by Genentech, Inc. on December 5, 2008, seeking to restrict the ability of laboratories to offer diagnostic tests to physicians and patients. The request threatens innovation in laboratory tests, would harm patient care and rests on flawed scientific and legal premises.

The Coalition's mission is to encourage the research, development, and commercialization of innovative diagnostic techniques. In contrast, the petition, by requesting that the FDA approve all laboratory tests, would delay the introduction of many critically needed diagnostic tests, and prevent others from ever being available. Further, although implied to be narrow, the petition is sweeping in scope. Genentech maintains that the Food and Drug Administration (FDA) should regulate all laboratory developed tests (LDTs) "for use in drug or biologic therapeutic decision making." LDTs are developed precisely for the purpose of helping physicians make therapeutic decisions for their patients, including the decision of which drug to prescribe. The overwhelming majority of LDTs fall within the scope of the petition.

Genentech's citizen petition relies on several incorrect assumptions. One of the most fundamental errors is that FDA review and approval is needed for all LDTs used in therapeutic decision-making "to ensure that claims made for the tests are scientifically proven." Genentech wrongly asserts that FDA approval is a prerequisite for claims to be considered "scientifically proven." FDA approval is not needed for a LDT's performance to be demonstrated. There are many other methods of establishing a LDT's performance, such as the publication of reproducible research findings in peer-reviewed publications. Doctors routinely use peer-reviewed published literature in making therapeutic decisions, including the decision to prescribe drugs for off-label uses that have not been approved by FDA.

In seeking to require FDA approval of all LDTs used to make therapeutic decisions, Genentech relies on statements which it alleges are "unsubstantiated" relating to LDTs affecting usage of its own products. There is a vast difference between not knowing how much data support a particular claim, and whether the claim is actually unsubstantiated. A lack of information about some LDTs does not justify a revolutionary change in the regulatory regime for laboratories. Moreover, imposing FDA regulation is not needed to redress false or misleading claims. The Federal Trade Commission has jurisdiction over that type of misconduct, as do the existing state agencies that regulate laboratories. Concerns about allegedly inaccurate statements can be readily -- and efficiently -- addressed within the existing regulatory framework.

The petition entirely ignores that a rigorous, well-established regulatory system already exists for LDTs. Laboratories and their tests need to meet the demanding requirements under the Clinical Laboratory Improvement Amendments (CLIA). They are also regulated by various states, as well as professional societies. Superimposing FDA approval of LDTs on top of the existing regulatory requirements would result in redundant -- and even conflicting -- regulation.

The Coalition for 21st Century Medicine, as well as many other organizations, questions whether FDA has the authority to regulate LDTs. However, as Genentech acknowledges, even if the FDA were to seek to regulate LDTs, the agency needs to proceed through notice-and-comment rulemaking. Until that process is completed, FDA cannot take enforcement action against laboratories for offering LDTs. Singling out individual laboratories for ad hoc enforcement, based on unstated criteria, can only result in arbitrary and capricious decisions. Asserting that FDA rulemaking is "a complex, lengthy process," Genentech requests that FDA punish companies before developing its regulations. The rights of laboratories to due process and fundamental fairness cannot be subordinated to a desire for haste.

Overturning the existing regulatory regime for LDTs would impose huge costs on laboratories. Even when a company possesses the data necessary to obtain FDA approval, companies still incur huge regulatory costs -- and delays -- in navigating the FDA approval process. Laboratories would incur significant additional costs to develop and implement systems that meet FDA's Good Manufacturing Practice regulations. Requiring FDA approval or clearance of every LDT used to make drug-related therapeutic decisions would cost the health care system a staggering amount of money. Nevertheless, Genentech's single paragraph on Economic Impact essentially ignores all of these direct economic costs, as well as all the health care costs that the health care system will bear because new LDTs will not be available. Genentech also entirely overlooks the costs to FDA of reviewing these submissions, and the impact on FDA's ability to handle its existing workload of diagnostic products.

The Coalition for 21st Century Medicine is committed to the development and dissemination of novel, scientifically robust and clinically useful diagnostic tests. Genentech's citizen petition requests the FDA to take actions that would preclude those objectives from being realized. We will be submitting to the docket a more detailed analysis explaining why the citizen petition should be rejected.

The Coalition for 21st Century Medicine represents some of the world's most innovative diagnostic technology companies, clinical laboratories, researchers, physicians, venture capitalists, and patient advocacy groups -- all linked by a common mission to develop advanced diagnostics that improve the quality of healthcare for patients.


'/>"/>
SOURCE The Coalition for 21st Century Medicine
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. AIDS Vaccine Advocacy Coalition Voices Disappointment in Trial Result
2. AIDS Vaccine Advocacy Coalition Calls for AIDS Vaccine Field to Work Together to Analyze STEP Study Data and Determine Best Course to Move Forward
3. Childhood Influenza Immunization Coalition Encourages Vaccination Throughout the Influenza Season
4. Cancer Cure Coalition Proposes Major Changes at the FDA
5. St. Jude Settles Century-Old Debate on Origin of Mammalian Network of Lymphatic Vessels
6. Pediatric Study Finds 21st Century Non-Contact Thermometer as Accurate as Conventional Thermometers
7. AIDS Healthcare Foundation Names Homayoon Khanlou, M.D. as its Chief of Medicine, U.S.
8. Results from Study Evaluating PROCRIT(R) in Intensive Care Unit Patients Published in New England Journal of Medicine
9. Personalized Medicine - The Genomic Revolution in Cardiac Care
10. Vaccine Study in New England Journal of Medicine Wrong in Concluding Mercury Exposures are Harmless, States SafeMinds
11. U.S. Preventive Medicine Acquires Specialty Disease Management
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/9/2016)... Feb. 9, 2016   AllCare Plus Pharmacy ... Gold Seal of Approval ® for Home ... performance standards. The Gold Seal of Approval ® ... commitment to providing safe and effective care.  ... Pharmacy underwent a rigorous on-site survey in January 2016. ...
(Date:2/9/2016)... LONDON , Feb. 9, 2016 The new report ... Acuity Business Research & Consulting group reveals that global diagnostic ultrasound ... expected to grow to US$ 7,466.3 million by 2019 at a ... market analysis of global ultrasound market has been analyzed for six ... , Asia-Pacific , Latin America ...
(Date:2/9/2016)... , Feb. 9, 2016 The global prefilled ... and it is expected to grow with a CAGR ... glass prefilled syringes segment dominated the global prefilled syringes ... --> --> The global market of ... due to increasing geriatric population, increasing demand for vaccines, ...
Breaking Medicine Technology:
(Date:2/9/2016)... , ... February 09, 2016 , ... Steven Douglas Associates ... of South Florida Event, an upscale fundraiser held in South Florida. The Inaugural What’s ... guests alike. This year the event will be held in a new, more causal ...
(Date:2/9/2016)... ... February 09, 2016 , ... Interstate ... after a disaster, announced today the acquisition of Hawaii DKI. Hawaii DKI is ... , “Investing in like-minded companies who excel at service and response helps support ...
(Date:2/9/2016)... ... February 09, 2016 , ... URise Products announces ... mobility device, the StandUp Walker. Made entirely in the USA, the StandUp Walker ... years. , StandUp Walker’s novel patent-pending design offers 2-in-1 benefits of a ...
(Date:2/9/2016)... ... 09, 2016 , ... Cirracore Enterprise Cloud, today announced that ... the cloud. Cirracore provides a secure VMware® vCloud Air based cloud that ... Transformation Solutions (TSL Partners) provides a full range of services from planning, discovery, ...
(Date:2/9/2016)... ... February 09, 2016 , ... BioPlus Specialty Pharmacy (BioPlus), one ... ‘Pay It Forward’ program into 2016. BioPlus partners with several non-profit patient foundations ... , “Since our Pay It Forward program began, we are proud to have ...
Breaking Medicine News(10 mins):