FDA Needs A New Set of Tools For Drug Approvals and Scrutinizing Consumer Advertising on Over the Counter and Food Products
Posted May 12 2010 11:36pm
Recently I had read in a couple places where the FDA should think about regulating medical records and when you look at where they are today, there’s no way they can bite off more right now as they have more than full plates to deal with. Not too long ago the agency lost their top scientific medical device advisor to Microsoft as well.
The agency is trying to get their own “Sentinel” data system up and running and had to give a grant to an insurance company to test and try the data aggregation systems being built. The FDA is not the only government agency in this mess with updating tools and infrastructure, it’s all over with most government agencies in the same boat after 8 years of an administration that sat on “snooze” control and didn’t see value in keeping up government technology.
Don’t forget we still have Social Security still hanging on with Cobol too. I think at the FDA today, everyone’s head has to be swimming all the time as we have new developments that require their attention daily and some of these areas are where the FDA has not gone before. I have my own little campaign going on for the use of cell phones with recalls and that issue is going to grow huge in a short amount of time. Kroger grocery stores does a better job with technology and recalls at present.
Anyway, long and short, more issues for the FDA to work through as well as facing that new left hook they get every day. Collaboration with other government entities has also escalated to a new level, where it is an absolute must today and not really a choice any more. BD
Relying on so-called biomarkers is confusing the entire process of drug development, the public and doctors alike, they said.
The FDA also needs to use the same strict standards for assessing health claims of food and supplements as it does for drugs, said the panel appointed by the Institute of Medicine, which advises the federal government.
The committee recommended a new framework the FDA could use for judging studies that companies provide to support health and safety claims for their products.
"Congress may need to strengthen FDA authority to accomplish this goal," the institute's report reads.
The committee's report focuses on biomarkers, which can include measures as simple as temperature. Common biomarkers include levels of cholesterol and blood sugar.
Drugs to treat diabetes are often approved simply because they lower blood sugar and heart drugs can win FDA approval because they lower cholesterol. But the report said this does not mean they make patients healthier.
"Right now the supermarket is a jungle of unsupported health-related claims," the group said in a statement.