Washington, D.C. (August 21, 2013) BIO applauds Rep. Michael Burgess (R-TX) and Rep. Jackie Speier (D-CA) for introducing the Medical Testing Availability Act of 2013 (H.R. 3005) to amend chapter V of the Federal Food, Drug, and Cosmetic Act to permit the sale of, and access to, "research use only" products in diagnostic tests. The passage of this legislation is critical to ensuring patient access to important research and clinical tools, and the research community’s access to reagents.
The following statement may be attributed to Jim Greenwood, President & CEO of the Biotechnology Industry Organization (BIO):
"Guidance recently released by FDA would make manufacturers responsible for downstream use of a product outside of a manufacturer’s control. FDA’s approach in the ‘Draft Guidance for Industry and FDA Staff - Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions’ is impractical for manufacturers to implement, and threatens patient access to important clinical and research tools that have been used in pathology laboratories for decades.
“We support efforts to ensure that these products are marketed appropriately as several of our member companies develop and market in vitro diagnostic technologies for a variety of research, investigational and clinical uses.
“However, to expand the definition of intended use to include downstream use of the product outside of a manufacturer’s control ignores legal precedent, and establishes a significant shift in the regulation of product promotion under the Agency’s jurisdiction.
“By creating a safe harbor for these targeted, ordinary business practices, the Bill allows for continued use of and access to research use only products. BIO appreciates that the Bill is narrowly tailored to address only those commonplace practices that FDA claims would constitute a ‘reason to know’ that a product is being used in a clinical diagnostic application under its newly promulgated standard.
“The biotechnology industry depends on a regulatory environment that encourages innovation and access to important research tools in order to speed life-saving and life-enhancing treatments and cures to patients who desperately need them. We look forward to working with the Congress and the FDA to move this legislation forward.”
For more information on personalized medicine and diagnostics, please visit http://www.bio.org/category/personalized-medicine.
Upcoming BIO Events
BIO Investor Forum
October 8-9, 2013
San Francisco, CA
BIO IPCC Conference
November 6-8, 2013
BIO Convention in China
November 11-13, 2013
Pacific Rim Summit on Industrial Biotechnology & Bioenergy
December 8-11, 2013
San Diego, CA
BIO CEO & Investor Conference
February 10 – 11, 2014
New York, NY
BIO International Convention
June 23-26, 2014
San Diego, CA