by Michael P. Douglas and W. David Dotson, PhD
An IOM report makes
recommendations that aim to ensure that progress in omics-based test
development is grounded in sound scientific evidence and is
reproducible, resulting in improved health care and continued public
trust in research. Another new IOM roundtable workshop report discussed
the differences in evidence required for clinical use, regulatory
oversight, guideline inclusion, coverage, and reimbursement of genomic
diagnostic tests and focused on ways to clarify pathways for using such
tests in clinical settings.
Recently, the NIH made a beta version of Genetic Test Registry (GTR) available
online. The GTR provides a central location for voluntary submission
of genetic test information by developers. The GTR includes information
on the test’s purpose, methodology, validity, evidence of the test’s
usefulness, and laboratory contacts and credentials. The information
provided is not verified by NIH, but assumed to be accurate by the
submitting party. The GTR will not obviate the need for evidence-based
evaluation of genetic tests and development of recommendations. However
it is on track towards becoming useful to advance research and clinical
practice.
So what are health care providers to do today when
considering ordering a genomic test to diagnose, prevent or ameliorate a
medical condition? Ultimately, providers and patients have to ask
whether or not such a test can help in management of a health condition,
and what is the balance of benefits and harms of such testing to the
patient, the family, the community and the healthcare system. Genomics
and related fields (“Omics”) are rapidly emerging, resulting in many
tests proposed to improve health. Since 2009, the CDC’s online GAPP Finder has
catalogued more than 400 emerging tests, most of which are related to
cancer. Unfortunately, beyond management of rare, single gene disorders,
most new tests are not ready for use in clinical practice. The question
is how do we know what is ready and what is not. After all, many people
would like to have access to their personal genome information
regardless of health related utility. This was reflected in the recent
readers’ response to our blog on the topic of personal genomics.
more... http://www.kevinmd.com/blog/2012/04/evidence-genomic-medicine.html
Showing posts with label IOM Report. Show all posts
Showing posts with label IOM Report. Show all posts
Monday, April 23, 2012
Tuesday, April 17, 2012
Collaboration for a Global Product Safety Net, from FDA Voice
By: Mary Lou Valdez
If it takes a village to raise a child, in today’s economy it takes the support and commitment of a global community to ensure the safety of the food we eat and the medications we rely on.
This point was made clear in an Institute of Medicine report released on April 4. The report was commissioned by the FDA as the agency addresses the challenges of global supply chains, international trade, and foreign sourcing of foods, feeds, and medical products. It complements the FDA Commissioner’s Report on Global Pathway to Product Safety and Quality released last summer.
Imports
of food and drug products regulated by FDA have increased by more than
13 percent per year since 2002, resulting in a threefold increase of
products produced outside of the United States. Almost 40 percent of the
fruits and nuts and 85 percent of the seafood consumed in America comes
from abroad. Similarly, more than 80 percent of the active
pharmaceutical ingredients used to make medicines are imported. To
ensure that the vast array of products Americans depend on are safe, FDA
focus can no longer be solely domestic – it must be global.
Since many of the products imported are from emerging and developing countries, the FDA asked the IOM to take a look at the regulatory systems in those countries to identify major gaps and to design a strategy for how the FDA, along with other regulators and stakeholders, can help to strengthen their regulatory systems and build capacity.
http://blogs.fda.gov/fdavoice/index.php/2012/04/collaboration-for-a-global-product-safety-net/
Mary Lou Valdez is FDA’s Associate Commissioner for International Programs and Director, Office of International Programs
If it takes a village to raise a child, in today’s economy it takes the support and commitment of a global community to ensure the safety of the food we eat and the medications we rely on.
This point was made clear in an Institute of Medicine report released on April 4. The report was commissioned by the FDA as the agency addresses the challenges of global supply chains, international trade, and foreign sourcing of foods, feeds, and medical products. It complements the FDA Commissioner’s Report on Global Pathway to Product Safety and Quality released last summer.
Imports
of food and drug products regulated by FDA have increased by more than
13 percent per year since 2002, resulting in a threefold increase of
products produced outside of the United States. Almost 40 percent of the
fruits and nuts and 85 percent of the seafood consumed in America comes
from abroad. Similarly, more than 80 percent of the active
pharmaceutical ingredients used to make medicines are imported. To
ensure that the vast array of products Americans depend on are safe, FDA
focus can no longer be solely domestic – it must be global.Since many of the products imported are from emerging and developing countries, the FDA asked the IOM to take a look at the regulatory systems in those countries to identify major gaps and to design a strategy for how the FDA, along with other regulators and stakeholders, can help to strengthen their regulatory systems and build capacity.
http://blogs.fda.gov/fdavoice/index.php/2012/04/collaboration-for-a-global-product-safety-net/
Mary Lou Valdez is FDA’s Associate Commissioner for International Programs and Director, Office of International Programs
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