Health and Medical News and Resources

General interest items edited by Janice Flahiff

[Report] Regulation of Clinical Tests: In Vitro Diagnostic (IVD) Devices, Laboratory Developed Tests (LDTs), and Genetic Tests

From the summary of the December 2014 report by the Congressional Research Service

In vitro diagnostic (IVD) devices are used in the analysis of human samples, such as blood or
tissue, to provide information in making health care decisions. Examples of IVDs include (1)
pregnancy test kits or blood glucose tests for home use; (2) laboratory tests for infectious disease,such as HIV or hepatitis, and routine blood tests, such as cholesterol and anemia; and (3) tests forvarious genetic diseases or conditions. More recently, a specific type of diagnostic test—called acompanion diagnostic—has been developed that may be used to select the best therapy, at the right dose, at the correct time for a particular patient; this is often referred to as personalized or precision medicine.


In June 2010, FDA announced its decision to exercise its authority over all LDTs. A provision in
the Food and Drug Administration Safety and Innovation Act of 2012 stipulates that the agency
“may not issue any draft or final guidance on the regulation” of LDTs without, “at least 60 days
prior to such issuance,” first notifying Congress “of the anticipated details of such action.” On
July 31, 2014, in fulfillment of this statutory requirement, the FDA officially notified the Senate
Committee on Health, Education, Labor and Pensions and the House Committee on Energy and
Commerce that it will issue draft guidance on the regulation of LDTs, and included the
anticipated details of that regulatory framework. On October 3, 2014, the FDA formally issued
these documents as draft guidance in the Federal Register, giving 120 days for comment.
The draft guidance identifies groups of LDTs that will be (1) exempt from regulation entirely; (2)
only required to meet notification and adverse event reporting requirements; and (3) required to
meet notification, adverse event reporting, applicable premarket review, and other regulatory
requirements. FDA will use the information obtained through the notification requirement to
classify LDTs, based on risk, using a public process involving advisory panels and public
comment. Once classification has taken place, the FDA will enforce premarket review
requirements, prioritizing the highest-risk tests. The agency anticipates the entire process of
bringing all LDTs into compliance will take nine years to complete.

From the summary of the December 2014 report by the Congressional Research Service

In vitro diagnostic (IVD) devices are used in the analysis of human samples, such as blood or
tissue, to provide information in making health care decisions. Examples of IVDs include (1)
pregnancy test kits or blood glucose tests for home use; (2) laboratory tests for infectious disease,such as HIV or hepatitis, and routine blood tests, such as cholesterol and anemia; and (3) tests forvarious genetic diseases or conditions. More recently, a specific type of diagnostic test—called acompanion diagnostic—has been developed that may be used to select the best therapy, at the right dose, at the correct time for a particular patient; this is often referred to as personalized or precision medicine.


In June 2010, FDA announced its decision to exercise its authority over all LDTs. A provision in
the Food and Drug Administration Safety and Innovation Act of 2012 stipulates that the agency
“may not issue any draft or final guidance on the regulation” of LDTs without, “at least 60 days
prior to such issuance,” first notifying Congress “of the anticipated details of such action.” On
July 31, 2014, in fulfillment of this statutory requirement, the FDA officially notified the Senate
Committee on Health, Education, Labor and Pensions and the House Committee on Energy and
Commerce that it will issue draft guidance on the regulation of LDTs, and included the
anticipated details of that regulatory framework. On October 3, 2014, the FDA formally issued
these documents as draft guidance in the Federal Register, giving 120 days for comment.
The draft guidance identifies groups of LDTs that will be (1) exempt from regulation entirely; (2)
only required to meet notification and adverse event reporting requirements; and (3) required to
meet notification, adverse event reporting, applicable premarket review, and other regulatory
requirements. FDA will use the information obtained through the notification requirement to
classify LDTs, based on risk, using a public process involving advisory panels and public
comment. Once classification has taken place, the FDA will enforce premarket review
requirements, prioritizing the highest-risk tests. The agency anticipates the entire process of
bringing all LDTs into compliance will take nine years to complete.

January 20, 2015 Posted by | Consumer Health | , , , , , , , , | Leave a comment

[Reblog] Food and health…again

Yes, this post is a bit left of center from most of my posts.
But it does raise some valid concerns.
The related articles are just a few ways some folks are trying their best to alert us and coax us into changing unhealthy food choices.

 

From the 23 August 2013 post at eek.ology

 

 

 

 

 

 

I found this on the image site imgur.com recently and it blew me away with its accuracy. I’m living in a country which seems to produce food largely based on fat, salt and sugar. I walk into the supermarket and have to check ingredients on cheese and yoghurt and jam and ice cream to avoid rBGH and high fructose corn syrup. I go to a pharmacy and they’re selling crisps and chocolate and cigarettes and booze. Things that were once simple aren’t anymore.  Once I just needed to worry about cage free eggs. Now I’m trying to toss up the environmental damage of the food miles of cheese from Europe vs. the health implications of local cheese from cows that have been treated with rBGH.

Wendell Berry is right. The connection between food and health (and indeed our environment), while it is so blatantly, blatantly obvious, is so frequently ignored.  We ignore what is in front of our noses in both the literal and metaphorical sense every single day, and our health is getting worse for it.

 

Some Related Organizations (variety of types & organizational values)

 

August 28, 2013 Posted by | health care, Nutrition | , , , , | 1 Comment

GMOs should be safety tested before they hit the market says AMA

OGM - ADN

OGM – ADN (Photo credit: Wikipedia)

From a 19 June 2012 article at the Chicago Tribune

The American Medical Association called for mandatory pre-market safety testing of genetically engineered foods as part of a revised policy voted on at the AMA’s meeting in Chicago Tuesday.

Currently biotech companies are simply encouraged to engage in a voluntary safety consultation with theFood and Drug Administration before releasing a product onto the market.

Some activists concerned about foods made with genetically modified organisms, or GMOs, had hoped the association would have gone so far as to support mandatory labeling of genetically engineered foods. But some still view the policy change as a major breakthrough.

“We applaud the AMA for taking the lead to help ensure a safe and adequate food supply,” said Anne Dietrich of the Truth In Labeling Campaign, which advocates labeling of genetically engineered foods. When Monsanto Co., the world’s largest biotech seed company, testified Sunday at the AMA committee hearing on the policy, its representative did not raise any objections to the mandatory safety assessment provision.

On Tuesday, however, Monsanto spokesman Tom Helscher would not say whether or not the company supports mandatory pre-market testing, only that the current voluntary consultation process “is working,” he wrote to the Tribune. “All of Monsanto’s biotech products, and to our knowledge all those of other companies, go through the FDA consultation process, which provides a stringent safety assessment of biotech crops before they are placed on the market.”

The AMA’s Dr. Patrice Harris said the testing provision was aimed at addressing public interests and ensuring public health….

June 20, 2012 Posted by | Nutrition, Public Health | , , , , , | 1 Comment

   

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